Podcasts about regulatory strategy

Send us a textIn this episode of the METUS Tech Show, the boys speak with Senior Director of Regulatory Strategy for Mitsubishi Electric US, Dana Fischer, as he updates us IRA, tax credits, and other governmental stuff.  We manage to sneak in a little ice cream too.Check out our youtube channel called the METUS Training Network.Thanks for listening! Please visit www.mitsubishicomfort.comContact us at metustechshow@hvac.mea.com

In this episode of Current Account, Clay is joined by Jenny Cosco, Global Head of Government Relations & Regulatory Strategy at LSEG, to discuss recent trends related to market risk and vulnerability. Jenny and Clay discuss some of the key market trends in 2025, how deeply volatile trends could be the pattern of the future, how markets seem to be combating volatility with resilience, regulatory frameworks that may bolster market stability and resilience, an overview of front-of-mind regulatory and market issues and much more. This IIF Podcast was hosted by Clay Lowery, Executive Vice President, Research and Policy, with production and research contributions from Christian Klein, Digital Graphics and Production Associate and Miranda Silverman, Senior Program Assistant.

On 4 December 2024 Future of Finance hosted a one-day event at the offices of AON in London. Entitled Digital asset custody: What do asset managers and asset owners need to know about digital asset custody and custodians?, the event attracted 160 registrants from asset managers, banks, custodian banks, digital asset custodians, exchanges, financial market infrastructures, insurers, investment consultants, law firms, regulators and technology vendors. This is an account of what they and the panellists contributed to the seven sessions that day, both live and in the multiple-choice questionnaire they completed in advance, the results of which are also published here.The panellists for this discussion were John Siena, Associate General Counsel and Co-Head of Regulatory Strategy at Brown Brothers Harriman (BBH); Monica Gogna, Partner and Head of the Financial Institutions Law Group at EY; Romin Dabir, partner at Reed Smith; and Yvonne Deane Harte, Director for Secondary Markets and Post Trade policy at UK Finance. Hosted on Acast. See acast.com/privacy for more information.

The UK's new digital markets competition regime came into force on 1 January 2025 and the Competition and Markets Authority (‘CMA') is already exercising its responsibilities in this area.  Join Robert MacDougall from Deloitte's EMEA Centre for Regulatory Strategy as he delves into how the UK's new digital markets regime is being implemented along with Cat Batchelor from the CMA's Digital Markets Unit. Learn more about the CMA's approach to pace, predictability, proportionality and process, featuring a range of insights for companies interested in this new digital regulatory framework. Don't miss this engaging and informative discussion!

In this episode, Ari speaks with Caroline Hill, Senior Director of Global Policy and Regulatory Strategy at Circle, about Circle's commitment to building with compliance at its core and the future of stablecoin regulation in the United States and globally. Caroline reflects on how her experience at the US Treasury shapes her perspective on regulatory policy and compliance strategy. Today's Guest: Caroline Hill, Senior Director of Global Policy and Regulatory Strategy, Circle Host: Ari Redbord, Global Head of Policy, TRM Labs

Liz kicks off this year's Medical Device Training Journey by interviewing Kelly Carty, who advises medical device companies on regulatory strategy throughout the product lifecycle. During their conversation, they dive deep into the clinical trials process, from how to develop the IFU to implementing best practices into a procedure, and how mandatory training can be a mitigation measure in the risk management process. Join Kelly and Liz as they discuss how a strong regulatary strategy can ensure companies have the best data, documents, and procedural steps to support their products. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle. Related Resources: Kelly Carty is a Co-founder of MedTech Strategy Advisors, LLC, a consulting company that advises medical device companies on regulatory strategy development and execution throughout the product lifecycle. Kelly spent 22 years working in the medical devices industry at companies ranging from small startups to large, well-established companies with a wide variety of devices and complex issues. She held positions of increasing responsibility, ultimately ending as the Head of Regulatory Strategy – Body Aesthetics for Allergan Aesthetics, an Abbvie Company. Following her time in industry, Kelly moved into consulting at Veranex, Inc. where she worked closely with her Co-Founder, Nada Hanafi. Together, Kelly and Nada routinely interface with FDA for their clients on novel product designs, pending submissions, and postmarket issues. Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠ Kelly Carty ⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠ About Cumby Consulting:    Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

We welcome Meredith Brown-Tuttle to AI Uncovered.  Meredith is the Chief Regulatory Strategist at Regulatorium, where she applies her 33 years of experience in the pharmaceutical and biologics industry. She specializes in working with small and medium-sized drug, biologic and combination product companies to navigate global regulatory strategy, intelligence and submission requirements. With a strong focus on innovation, Meredith is dedicated to revolutionizing regulatory science by integrating AI and in silico modeling into every stage of drug development. Most recently, Meredith has focused on advancing global regulatory science through the development of AI tools, aiming to streamline submission processes and improve outcomes for the industry. Her vision includes a future where entirely digital INDs, BLAs and NDAs become standard practice, supported by the widespread use of in silico modeling, digital twins and federated data sharing to enable collaboration without compromising proprietary information.In this episode, Tim  and Meredith explore the evolving landscape of global regulatory strategy and how AI can revolutionize regulatory science. Meredith shares insights from her extensive career, including her experience in crafting INDs and NDAs, her thoughts on transforming data validation standards across the industry and providing strategic guidance to companies navigating complex regulatory requirements. She also delves into the challenges and opportunities presented by AI. In addition to her work at Regulatorium, Meredith serves as a board member at the Alliance for Artificial Intelligence in Healthcare (AAIH), showcasing her commitment to leveraging innovation in regulatory affairs. Meredith is also an accomplished author of over 70 articles and two books, and she has trained thousands of professionals on writing INDs and conducting effective regulatory submissions. Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team and uses his expertise to manage the wonderful world of product.

The 2025 edition of the annual Financial Markets Regulatory Outlook sets out the most important regulatory and supervisory themes in 2025 – both for the industry as a whole, and at the sector level. Tune in to listen to a robust discussion between host Liam Girvan (Associate Director, EMEA Centre for Regulatory Strategy), Suchitra Nair (Partner, EMEA Centre for Regulatory Strategy) and David Strachan (Advisor, EMEA Centre for Regulatory Strategy), on the key regulatory and supervisory trends that will impact the financial services industry in 2025 – the discussion covers both, a bird's eye view on major trends and mini dives into key issues affecting sectors. Buckle up!  the insights in this episode are intended to help C-suite individuals at financial services firms prepare for strategic decision making, risk management and implementation.

In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact on the overall success of drug development programs. The episode also explores the integration and collaboration required across various functions like R&D, quality, regulatory, and commercial teams to create and refine a robust TPP.00:00 Introduction and Welcome00:26 Meet Marta: CEO of Radius Research00:58 Understanding Target Product Profiles (TPPs)01:44 The Importance of TPPs in Drug Development01:59 Defining a TPP03:22 TPP as a Strategic Document05:28 TPP in Preclinical and Clinical Stages07:09 Challenges and Misconceptions in TPP Development14:27 Regulatory Considerations for TPPs14:53 Sections of a TPP39:07 Understanding Toxicology Evaluations39:34 FDA Requirements for Pre-IND Talks39:51 TPP and Toxicity Thresholds41:41 Go/No-Go Criteria in TPP42:50 PKPD and Drug Distribution45:40 Drug Formulation and Quality Attributes46:36 Regulatory Strategy and 505(b)(2) Pathway52:34 Differentiation and Risk Assessment01:03:42 Transition from Discovery to Development01:07:48 Combination Products and Delivery Systems01:09:35 Conclusion and Contact InformationMarta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer. She can be reached at mnew@radyusresearch.com

An academic-turned-practitioner, Michelle Frasher, PhD, CAMS brings over 20 years of subject expertise in geopolitics, finance, terrorism, and data privacy with leadership experience in leading multi-disciplinary teams to build AML/CFT and Sanctions compliance products and services for a global clientele. She is currently the Head of Compliance and Regulatory Strategy at the AI regulatory technology firm, Silent Eight, and previously held key leadership positions at LexisNexis Risk Solutions as Director of Global Content for WorldCompliance, and Sr. Director of Financial Crime Compliance Practice at Moody's Analytics, where she led program implementation, regulatory analysis and engagement, product development, and client consultations on best practices across multiple business lines and sectors. An experienced speaker and author, Dr. Frasher's work has been featured in Harvard Business Review, American Banker, CoinDesk's Consensus, and SWIFT's Sibos, among others. She is an expert with the EU AML/CFT Global Facility on Beneficial Ownership, Privacy and Data Sharing, an external analyst with Oxford Analytica, a Forbes Business Council Member, and a standing member of the Privacy Research Group at the NYU School of Law. Frasher earned a PhD in history focusing on International Political Economy from Texas A&M University, holds multiple MA and BA degrees in political science, history, and foreign languages, and is a Certified Anti-Money Laundering Specialist. In 2014, she was Fulbright-Schuman Scholar to Belgium and Malta (sponsored by the US State Department and European Commission) on US-EU financial data sharing for transatlantic counter-terrorism cooperation. Listen to this insightful RIA episode with Dr. Michelle Frasher about navigating financial crime compliance with AI. Here is what to expect on this week's show: - How Silent Eight uses human-centered and explainable AI to help global banks detect and manage risks related to money laundering, financing terrorism, and sanctions. - How Silent Eight's AI solutions provide a comprehensive audit trail, ensuring transparency and regulatory compliance. - Why it's critical to translate complex regulations into actionable policies and procedures for financial institutions. - How the new AML/CFT regulatory rules for RIAs take effect on January 1st, 2026, with significant implications for the industry. - How the evolving regulatory environment underscores the need for RIAs to enhance their compliance procedures and staff training. Connect with Dr. Frasher: Links Mentioned: https://www.silenteight.com/ X: @_SilentEight LinkedIn: linkedin.com/company/silenteight Learn more about your ad choices. Visit megaphone.fm/adchoices

In this special edition of The Clean Energy Revolution, we bring you highlights from a panel discussion, ‘Women Leading the Energy Transition', hosted at New York University during Climate Week.The discussion is moderated by Sandy Grace, Vice President of US Policy and Regulatory Strategy for National Grid, who sits down to talk with women working in various roles addressing the clean energy transition.You'll hear from panellists including Naomi Boness (Stanford University), Hadia Sheerazi (Rocky Mountain Institute), Amy Myers Jaffe (NYU), and one of this podcast's co-hosts Dr. Carolyn Kissane (NYU), as they share their career journeys, current challenges, and opportunities needed to ensure a robust, equitable and sustainable energy transition.Be sure to tune in to hear about the impactful work happening in policy, academia, NGOs, and startups, as well as the incredible and inspirational stories of some of the women at the forefront of the energy transition. This special episode is not to be missed.

This ToxChats© episode is part of a series on the different career paths in the field of toxicology. In this episode, we interview Dr. Marcus Delatte on his career path to his current position as the Vice President of Regulatory Strategy at the consulting company, Allucent. Dr. Delatte also shares his experiences as a pharmaceutical consultant in toxicology.

Connecting more clean energy projects to the electricity grid is one of the most critical issues in driving the clean energy transition. Legacy ‘first come first served' approaches, along with a rapid growth in the number of projects looking to connect, have led to stalled, or "zombie" projects waiting in the queue to be connected - so what's being done to resolve this? Across the world, it's estimated we'll need 11,000 gigawatts by 2030 to triple renewable energy capacity. In the UK, electricity capacity may need to double by 2030 to achieve net zero goals, and in the US, renewable electricity deployment needs to significantly ramp up to achieve a zero-carbon energy supply. To discuss the rise in connection applications and the plans to accommodate them, Laura speaks to Ruth Shaw, Customer and Stakeholder Experience Manager in Electricity Transmission at National Grid. Together they look at groundbreaking projects like Dogger Bank – the world's largest offshore wind farm – and how these projects are providing the blueprint for a streamlined connections process. On the other side of the Atlantic, Carolyn is joined by Sandy Grace, Vice President of US Policy and Regulatory Strategy for National Grid, to uncover how the US is tackling similar challenges. Innovative solutions like bi-directional flows and vehicle-to-grid technology are poised to revolutionize the grid. Sandy explains how they work, and analyses the need for regulatory reforms to speed up connections to the grid. Find out more about the upgrades to the grid happening in the UK and US at https://www.nationalgrid.com/the-great-grid-upgrade and https://upstateupgrade.nationalgrid.com/

The extremely wide remit of Consumer Duty has meant that firms across financial services have had their hands full over the last couple of years – but what's next? After the July 2023 deadline, what do firms need to focus on? identifying vulnerable consumers, assessing price and value, and ensuring that robust data is available to monitor and prove good outcomes, are just a few of the things that firms will need to continue work on. In this episode of Regulated Radio, host Isha Gupta interviews experts Kareline Daguer, Director of Insurance at the EMEA Centre for Regulatory Strategy, Charlotte Wightwick Head of Conduct at the ABI and Paul Fraser, Director, and Consumer Duty lead for investment management at Deloitte on this issue.

Let us know how we're doing - text us feedback or thoughts on episode contentIn order to meet the ambitious climate goals as enshrined in New York's Climate Leadership and Community Protection Act (CLCPA), the state is about to embark upon a far reaching program to ratchet down emissions from heavy emitters. The Cap and Invest program has a lot of similarities to RGGI and other Cap & Trade efforts, with some key nuances on how New York is planning on using this tool to transition to a clean energy economy.Karsten Barde, Director of US Policy and Regulatory Strategy for National Grid, joins Paul to discuss the construct of the program, who it's likely to impact, and what to expect as it navigates its way through this preliminary structuring phase.For further reference:Karsten BardeNew York Cap and InvestRegional Greenhouse Gas InitiativePreproposal Stakeholder Outreach - Preliminary Scenario AnalysesFollow Paul on LinkedIn.

The 2024 Sustainability Regulation Outlook report is now live! It covers the key implications of sustainability related regulations across financial services and non-financial services. The report contains key insights on pivotal topics with crucial consequences for financial services and the real economy such as decarbonisation, greenwashing, sustainability reporting and circularity. In this episode, Isha Gupta from the EMEA Centre for Regulatory Strategy is joined by authors of the report and senior managers in Deloitte's Sustainability Regulation Hub, Magda Puzniak-Holford and Ramon Bravo Gonzalez to discuss what firms should be focusing on to prepare for the deluge of sustainability related regulations. The trio are privileged to be joined by Jane Gimber, Head of Sustainability from Fleishman Hillard a consulting firm based in Brussels, who provides key insights on the impact that the upcoming European Parliamentary elections will have on all of this.

In light of the SEC's new climate-related disclosure rule, the ESG Talk and Off the Books podcast crews huddled to make sense of it all.In this episode, Steve Soter asks Mandi McReynolds, head of ESG at Workiva, and Andie Wood, Vice President of Regulatory Strategy at Workiva, for their thoughts.Then Jonathan Gregory, North America Controller at The Hershey Co., and Alan Wilson, Partner at WilmerHale, share their initial reactions, what surprised them in the rule, and some of their questions about the rule in the weeks and months to come.Subscribe to ESG Talk and Off the Books as we continue the conversation in the year ahead.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with Parexel regulatory experts Mwango Kashoki, M.D., Senior Vice President, Global Head of Regulatory Strategy, and Steve Winitsky, M.D., Vice President, Technical - Regulatory Strategy, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.  In today's episode, Fierce Pharma's Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA's decision and to discuss its implications for CAR-T candidates and their developers down the line.   To learn more about the topics in this episode:  FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe Amid high-profile CAR-T safety probe, FDA's Peter Marks offers first glimpse at data under review  See omnystudio.com/listener for privacy information.

In this episode, we meet Zina, a remarkable woman who overcame immense challenges to carve her own path. Uprooted from her Ugandan home, Zina found herself in a new land, facing changes in culture and having to ground herself in her life. Yet, she persevered, fueled by her unwavering dedication. Zina's story is one of resilience, passion, and a relentless pursuit of knowledge. Dive into her captivating tale, discover her unique perspective on healthcare innovation, and regulatory strategy, and learn how her journey continues as she embarks on a new chapter in the exciting world of digital health!Support the show

The first Space Force Guardian is going to space this August as part of the NASA SpaceX Crew-9 mission to the International Space Station. Rocket Lab is looking to raise $275 million by offering financial securities known as Convertible Senior Notes. NOAA's Office of Space Commerce and SpaceX have entered into a no-exchange-of-funds Cooperative Research and Development Agreement (CRADA), for research and development activities related to automated collision avoidance and satellite conjunction assessment screenings, and more. Remember to leave us a 5-star rating and review in your favorite podcast app. Miss an episode? Sign-up for our weekly intelligence roundup, Signals and Space, and you'll never miss a beat. And be sure to follow T-Minus on LinkedIn and Instagram. T-Minus Guest Our guest today is Valerie Vasquez, Director of Global Public Policy and Regulatory Strategy at True Anomaly. You can connect with Val on LinkedIn and learn more about True Anomaly on their website. Selected Reading Space Force Guardian set to launch to International Space Station on NASA mission Rocket Lab Announces Proposed Offering of $275 Million Convertible Senior Notes | Business Wire NOAA, SpaceX Enter Cooperative Agreement for Automated Collision Avoidance R&D Space Force to start charging more spaceport fees this summer Space Development Agency Awards Momentus Contract Modification to Develop Defense Applications for Vigoride Orbital Service Vehicle | Business Wire  “Pact for the Future” UN Office for Outer Space Affairs and Exolaunch sign agreement to launch CubeSats into space POLARIS Update  ispace Signs Memorandum of Understanding with mu Space for Future Lunar Missions America, China and Russia are locked in a new struggle over space Launch Records Topple in 2024 with Busiest January of Space Age Florida-based BlackStar Orbital unveils southern Arizona spacecraft factory The Space Race | National Geographic Documentary Films T-Minus Crew Survey We want to hear from you! Please complete our 4 question survey. It'll help us get better and deliver you the most mission-critical space intel every day. Want to hear your company in the show? You too can reach the most influential leaders and operators in the industry. Here's our media kit. Contact us at space@n2k.com to request more info. Want to join us for an interview? Please send your pitch to space-editor@n2k.com and include your name, affiliation, and topic proposal. T-Minus is a production of N2K Networks, your source for strategic workforce intelligence. © N2K Networks, Inc. Learn more about your ad choices. Visit megaphone.fm/adchoices

On this episode of the inSecurities podcast, Chris and Kurt chat with Martha Legg Miller, the Vice President of Public Policy and Regulatory Strategy at Fidelity Investments and former Director of the SEC's Office of the Advocate for Small Business Capital Formation. Martha talks about the role of the Advocate for Small Business Capital Formation, highlights key takeaways from the Office's 2023 Annual Report, and discusses recent SEC rulemaking proposals, including the Predictive Data Analytics (PDA) and Climate Risk Disclosure rules.

In this episode of the Space Policy Pioneers Podcast, host Andy Williams speaks with Josh Ingersoll, a Senior Manager of Regulatory Affairs at Astranis Space Technologies. The discussion focuses on the role of a regulatory engineer and a spectrum management expert in the space industry. Josh also shares insights about necessary skills and relevant tools like Visualyse software, the interaction between engineers and regulatory bodies, regulatory strategy, and the importance of technical knowledge in policy roles. He further discusses possible career paths, including opportunities in the public, private, and law sectors. Episode guide 00:05 Introduction to the Space Policy Pioneers Podcast 01:34 Understanding the Role of a Regulatory Engineer 02:40 The Importance of Spectrum in the Aerospace Industry 03:18 The Role of Regulatory Engineers in Satellite Communications 04:52 The Intersection of Regulatory Engineering and Public Relations 05:24 Understanding License Applications in Satellite Communications 06:09 The Role of Regulatory Engineers in Company Strategy 07:15 The Work of Astranis Space Technologies 10:10 The Impact of Spectrum on the Satellite Industry 10:22 The Role of Regulatory Strategy in Spectrum Management 16:40 The Day-to-Day Life of a Regulatory Engineer 17:13 The Importance of Technical Skills in Regulatory Engineering 19:08 The Role of Education in a Regulatory Engineering Career 22:58 Career Paths in Spectrum Management 27:22 The Importance of Networking in the Space Industry 34:10 The Big Picture: The Future of the Space Economy Links and Resources Visualyse software: https://www.transfinite.com https://www.transfinite.com/content/downloadsvisualyse Spectrum Policy Lab: Olin College https://www.osstp.org George Washington University space policy institute: https://spi.elliott.gwu.edu Georgia tech space lab: https://www.cstar.gatech.edu Mariel Borowitz: https://www.linkedin.com/in/marielborowitz/ MIT Technology policy program: https://tpp.mit.edu Space Generation Advisory Council https://spacegeneration.org Polaris news letter https://payloadspace.com Space Companies Astranis: https://www.astranis.com Amazon Kuiper: https://www.aboutamazon.com/what-we-do/devices-services/project-kuiper Kuiper Jobs: https://amazon.jobs/content/en/teams/devices-services/project-kuiper ViaSat: https://www.viasat.com/ Boeing: https://www.boeing.com/ Northrop Grumman: https://www.northropgrumman.com/ Link Global: https://lynk.world/ SpaceX: https://www.spacex.com/ Planet: https://www.planet.com/ Law firms servicing the space sector Hogan Lovells https://www.hoganlovells.com/ DLA Piper: https://www.dlapiper.com/ US Government bodies involved in space policy FCC space bureau: https://www.fcc.gov/space NASA office of science and technology policy https://www.nasa.gov/otps/otps-about-us/ Office of Space Commerce https://www.space.commerce.gov White House Office of science and technology policy https://www.whitehouse.gov/ostp/ Not mentioned by Josh, but for completeness, National Space Council: https://www.whitehouse.gov/spacecouncil/ Space Force: https://www.spaceforce.mil/ NOAA: https://www.noaa.gov/ Additional Resources: Overview of US space regulatory landscape: https://spacelaws.com/articles/space-licensing-in-the-united-states/ European Space Policy Institute report https://www.espi.or.at/wp-content/uploads/2023/10/ESPI-Space-Spectrum-Policy-Report-1-1.pdf ITU guidebook: https://www.itu.int/hub/2023/10/itus-handbook-on-small-satellites-advancing-the-global-satellite-industry/

Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in the industry.Join us as we delve deep into crucial topics such as biases in medical device testing, the evolving approach of the FDA, and the importance of user-centric design. This episode offers a comprehensive look into the dynamic and ever-evolving realm of medical technology, emphasizing the balance of innovation and regulation.Highlights of the episode include:Skin Tone Bias in Medical Devices: Nada Hanafi spotlighted the biases in pulse oximeters, shedding light on how these devices often fail to perform efficiently across varied skin tones. A lack of diversity in validation tests, mostly relying on Caucasian young men, resulted in compromised health outcomes for others.Evolution and Transparency of the FDA: Nada traced the journey of the FDA, illustrating its transformation towards greater transparency and predictability. Emphasizing the human touch behind FDA's decisions, she dispelled the myth of the FDA being an impersonal "black box".Global Regulatory Movements: Highlighting a shift in the MedTech landscape, Nada pointed to the trend of global regulatory harmonization, particularly noticeable in the realm of software-based medical devices.Importance of User-Centered Design: Nada and the panel emphasized the significance of involving patients early in the design phase. Using tools like personas and human factor tables can lead to products that truly cater to users' needs, ensuring both usability and safety.Embracing Learning in MedTech: Nada's hope for companies to learn from past oversights and adapt to changing regulations stressed the crucial role of iteration and learning in medical device innovation.Navigating Modern MedTech Challenges: From addressing the significance of thorough documentation practices to discussing the challenges of regulating AI-driven medical devices, the discussion underscored the ever-evolving MedTech arena and the imperative need for regulators to stay updated.This episode paints a comprehensive picture of the medical device industry, addressing both its challenges and its advancements.Quote:"Medical devices shouldn't be designed with a one-size-fits-all approach. We've seen firsthand the impact of biases, like with pulse oximeters. It's crucial that we validate devices across diverse populations to ensure safety and efficacy for all."Reference Links:Nada HanafiMedTech ColorMedTech InnovatorVeranexEtienne NicholsTrue Quality RoadshowGreenlight Guru AcademyGreenlight Guru Software

Uptake of biosimilars is lagging in the US, but why? In this episode, Sarah interviews Juliana M. Reed, Executive Director of the Biosimilars Forum, to find out the real barriers to widespread access to biosimilars, and how these problems could be addressed.Julie discusses the role of pharmacy benefit managers (PBMs) and the incentives that keep them from listing most biosimilars on their formularies. She applauds the recent launch of multiple new biosimilars for the blockbuster biologic Humira and explains why this moment is pivotal for the biosimilars industry and the US healthcare system as a whole. Mentioned during this episode:Interview with Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis – Xtalks Life Science Podcast Ep. 110For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

Lex interviews seasoned fintech expert Teana Baker-Taylor - Circle VP of Policy and Regulatory Strategy EMEA. Circle began as a peer-to-peer payments technology company that now manages stablecoin USDC, a cryptocurrency the value of which is pegged to the U.S. dollar. Teana discusses her journey from traditional finance to the frontier of blockchain and crypto exchanges. Together Lex and Teana explore the tangible economic impacts of banking and navigate the complex digital asset landscape, focusing on the unique role of USDC as a leading stablecoin. Additionally, they touch on the underlying mechanics of USDC and the intrinsic investment risks in the stablecoin space. Concluding by pondering the potential of stablecoins like USDC in the emerging metaverse, a new digital realm with endless possibilities. MENTIONED IN THE CONVERSATION Circle's Website: https://bit.ly/3CwWfL5Teana's LinkedIn profile: https://bit.ly/3Nw8yxF Topics: crypto, blockchain, tokenization, web3, defi, stablecoins, metaverse, AR/VR Companies: Circle, USDC, Eurocoin, Terra Luna, Metamask, Apple ABOUT THE FINTECH BLUEPRINT 

In this episode, Sarah interviews Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis, about the challenges of bring biosimilars to market. Dr. Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines. Sarah and Dr. Woollett also discuss Samsung Bioepis' first US Biosimilar Market Report (linked below) and some of its key findings on biosimilar cost savings, uptake and market share. She also shares the way forward to help biosimilars see broader use both in the US and Europe.Read about the publications mentioned in this episode here:Samsung Bioepis' First US Biosimilar Market ReportA 'Global Reference' Comparator for Biosimilar DevelopmentAn Efficient Development Paradigm for BiosimilarsComparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized RelianceInterchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical OneThe Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right QuestionFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featuredSocial Post:

Welcome to FinTalk by Vermeg, the leading podcast in FinTech and RegTech that addresses the most pressing topics in the financial industry.  In the third episode of season 2, our host Jawad Akhtar welcomes back James Phillips, Founder and Consultant, RegTech Innovate and former Global Head of Regulatory Strategy at Vermeg to discuss the opportunities and risks in regulatory compliance and resilience. During the episode, James Phillips shares his insights on the critical elements of operational resilience, change detection, horizon management, and regulatory reporting. James emphasises the importance of taking a step back before adopting RegTech solutions and re-evaluating the fundamental processes and data needed for the firm to achieve regulatory compliance and operational resilience.  This episode of FinTalk covers:  The definition of operational resilience and why it's crucial in today's financial landscape The role of RegTech in achieving operational resilience, including its use in regulatory reporting, risk management, and compliance The importance of data in achieving operational resilience and how firms can capture and use it effectively The emerging trends and regulations that will shape the RegTech landscape in the coming years 

The Consumer Financial Protection Bureau issued its final rule to implement Section 1071 of the Dodd-Frank Act. What will this rule mean for your institution? Section 1071 amended the Equal Credit Opportunity Act to require financial institutions to collect and report certain data in connection with credit applications made by small businesses and small farms, including women- or minority-owned entities. Randy Salser, President of NAFCU, digs into the new rule with two regulatory experts from Wolters Kluwer, both of whom are former federal regulators, to uncover the “what's”, “who's” and “when's.” Experts also dive into what credit unions can do today to prepare, and what to keep in mind as they build out systems to comply with 1071.   Additional topics include: Substantive differences between the DRAFT rule to the FINAL rule; Key dates to monitor; and Demographic information that needs to be collected and what credit unions need to know.   Speakers: Timothy Burniston, Senior Advisor, Regulatory Strategy, Wolters Kluwer Jason Keller, Associate Director, U.S. Advisory Services, Wolters Kluwer   Timothy.Burniston@wolterskluwer.com Jason.Keller@wolterskluwer.com

On this episode of the METUS Tech Show, we bring on Director of Regulatory Strategy for Mitsubishi Electric, Dana Fisher. Dana provides us with important refrigerant and IRA updates.Thanks for listening! Please visit www.mitsubishicomfort.comContact us at metustechshow@hvac.mea.comThanks for listening! Please visit www.mitsubishicomfort.comContact us at metustechshow@hvac.mea.com

The second episode in this series sees Jessica speaking to David Strachan, Deloitte, Partner, Head of EMEA Centre for Regulatory Strategy and Ruby White, Associate Director, Risk Advisory and discussing the topic of ‘Greenwashing' within the IMW sector.

The FDA Group's CEO, Nick Capman, sits down with Regulatory Attorney Christine P. Bump to discuss the current regulatory landscape for medical devices and the importance of developing a thoughtful regulatory strategy. Discussion points include: » The three classifications of medical devices and the various regulatory submission types — each with different risk levels, required data, costs, and approval timelines. » The costs associated with FDA approval. » Why it's important to craft a regulatory strategy early, even at the product concept stage, to determine device functionality and anticipate FDA requirements. » The challenges that the rapidly evolving nature of software, algorithms, and AI present for the FDA's traditional device paradigm. » The benefits of pre-submission meetings with the FDA, which provide valuable feedback and insights to streamline the submission process. » The differences between regulatory attorneys and consultants. » The common pitfalls for companies navigating the FDA approval process, such as insufficient budgeting and lack in-house expertise. » The importance of planning well in advance and adjusting operational goals to align with regulatory requirements. » The importance of understanding product claims to avoid regulatory complications. Christine is a regulatory attorney with more than 15 years of experience developing and implementing FDA strategies for cutting-edge technologies. As the founder of Penn Avenue Law & Policy, she focuses on devices, software as a medical device, digital health, diagnostics, wellness, genetics and genomics, and advertising and promotion. She advises CEOs, scientists, and teams of all levels regarding regulatory pathways, clinical investigations, premarket submissions, pre- and postmarket compliance, and promotional issues. She counsels a variety of clients, including start-ups, national and multi-national corporations, venture capital groups, and portfolio companies on navigating the FDA process. https://www.pennavenuelaw.com/ Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The Inflation Reduction Act allocates billions for home and building upgrades over the next ten years; these rebates and incentives can cut energy bills, reduce energy burdens, improve public health, and slash emissions, but state and tribal governments must work quickly to develop and implement well-designed programs to realize their full potential. This episode features energy policy researchers Dr. Yunus Kinkhabwala of PSE Healthy Energy and Dr. Arjun Makhijani of the Institute for Energy and Environmental Research, as well as heat pump and energy efficiency expert Dana Fischer with Mitsubishi Electric US discussing program design, data-driven approaches, and strategies that help people, especially low- to moderate income households and underserved communities, benefit from new funding. Guest BiosDr. Arjun Makhijani, PhD is the President of the Institute for Energy and Environmental Research holds a Ph.D. in engineering (specialization: nuclear fusion) from the University of California at Berkeley. He has produced many studies and articles on nuclear fuel cycle related issues. He is the principal author of the first study  on energy conservation potential in the U.S. economy. Most recently, Dr, Makhijani has authored Carbon-Free and Nuclear-Free: A Roadmap for U.S. Energy Policy (IEER Press), the first analysis of a transition to a U.S. economy based completely on renewable energy. He is the principal editor of Nuclear Wastelands and the principal author of Mending the Ozone Hole, both published by MIT Press.Dr. Yunus Kinkhabwala, PhD is a Senior Data Scientist, PSE Healthy Energy, where he develops sophisticated data-driven models to guide decision making and policy. Projects include optimizing the geospatial siting of solar and storage resilience hubs for vulnerable populations and estimating detailed household energy usages and costs to investigate impacts of policy scenarios aimed at improving energy affordability for low-income households. He received his PhD in Applied Physics from Cornell University as a National Science Foundation Graduate Research Fellow and holds a BS in Physics from the University of Illinois at Urbana-Champaign. Dana Fischer is the Director of Regulatory Strategy at Mitsubishi Electric US and has been with Mitsubishi Electric for 5 years working with individual homeowners and utility and industry organization and to the US Secretary of Energy. He was the Program Manager of the Home Energy Savings Program at Efficiency Maine and established the still active residential rebate and loan programs for weatherization, conventional heating systems, and heat pumps. He also has background in municipal finance, solar thermal, and ultra-high purity manufacturing.To dig in deeper, check out these must-read resources: Energy Affordability in Maryland: Integrating Public Health, Equity, and Climate | PSE Healthy Energy (February 2023)Mitsubishi Electric http://us.mitsubishielectric.comPSE Healthy Energy https://www.psehealthyenergy.orgInstitute for Energy and Environmental Research https://ieer.orgEfficiency Maine Heat Pump Program https://www.efficiencymaine.com/about-heat-pumps/

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today's episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they're ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in anticipation of the VALID actThe importance of a contingency planThe criteria for a legitimate LDTSpecific parameters to define an LDTLabelingTechnologyRiskRequiring hospitals to put LDTs through institutional review boardsBetter oversightCreating a EUA-like pathwayMemorable quotes from Mike Drues:“Even from a technology perspective, the technology of these LDTs is becoming much much more complicated.”“Long story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.”“I'm a biomedical engineer first and a regulatory consultant second. And that's the order we should think about these things.”“Even though I'm a regulatory consultant, I'm not a fan of creating new regulation.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What's the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today's episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes to LDTsWhy non-invasive LDTs can be listed as class 3Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn't regulate.”“Remember, regulation is about the interpretation of words.”“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it's developed.”“If the hospital does one thing, they're treated one way; if a company does exactly the same thing, they're treated another way. Something's not quite kosher about that logic.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this special segment, we're featuring web3 investors, founders and mentors such as Joey Krug from Pantera Capital, Matthew Graham from Sino Global Capital, Teana Baker-Taylor from Circle, Sam Williams from Arweave, John Wu from Ava Labs, Clarisse Hagege from Dfns, Sean Lee from Odsy, Tim Bos from ShareRing and Michelle Tsing from GRI. Included in this episode are some of the most helpful insights that these web3 leaders have shared with us over the past year and a half. The common thread you'll hear from all of them is that the things that make a great web3 project or startup focus a heckuva lot more on humanity than technology. FEATURED VOICES: Teana Baker-Taylor, now VP of Policy & Regulatory Strategy at Circle, on ep 163 John Wu, President of Ava Labs, on ep 164 Michelle Tsing, web3 governance advisor, on ep 161 Matthew Graham, CEO of Sino Global Capital, on ep 165 Joey Krug, co-CIO of Pantera Capital, on ep 166 Tim Bos, founder and CEO of ShareRing, on ep 169 Clarisse Hagege, co-founder and CEO of Dfns, on ep 202 Sean Lee, co-founder of Odsy Network, on ep 201 Sam Williams, co-founder and CEO of Arweave, on ep 205 LINKS Leave a review and subscribe on Apple Podcasts | Spotify Check out our MoneyNeverSleeps website and email us at info@moneyneversleeps.ie Follow us on Twitter: MoneyNeverSleeps | Eoin Fitzgerald | Pete Townsend --- Support this podcast: https://podcasters.spotify.com/pod/show/moneyneversleeps/support

Finance, meet Sustainability. On this episode of the podcast, I spoke with Andromeda (Andie) Wood who is Vice President for Regulatory Strategy for Workiva. She is an expert in the role of technology in corporate reporting, taxonomy design and data modelling, and holds a wealth of knowledge and deep understanding of the impact of EU and UK regulation on global firms, particularly in the areas of corporate transparency and ESG. There is an undeniable global shift towards greater standardisation in reporting ESG initiatives across markets.As it stands, corporate reporting comprises the financial statements and management reports of companies, including non-financial and corporate governance statements, as well as country-by-country reporting. Under the new directive, reports would also include sustainability information.While new standards consolidate several diverse formats previously used for reporting on ESG progress, Andie explains why transforming standards will cultivate a more hygienic reporting culture that will champion ESG results.We covered a lot of ground in this podcast, such as:Push for improvement: These new standards address a worrying lack of clarity on how to report on sustainability, including information on methodology requirements, to more accurately highlight failure pointsFuture-proof ESG reporting: They will help businesses to mitigate challenges and prepare for the unknown by implementing processes that establish flexibility and controlAcknowledging that ESG plays a direct role in top-line growth: New standards establish critical business success factors, highlighting the role of ESG and encouraging businesses to integrate it into the overall business strategyMoving towards international comparability: An incremental, but mindful, transition towards transparent reporting will help to build up a rich history of reporting across regions which investors can use to better judge business progress, both individually and competitivelyThis was an interesting podcast and introduced me to the link between finance and sustainability.More on AndieAndie on LinkedInAndie on TwitterAndie's insights at WorkivaYour Host: Actionable Futurist® Andrew GrillFor more on Andrew - what he speaks about and recent talks, please visit ActionableFuturist.com Andrew's Social ChannelsAndrew on LinkedIn@AndrewGrill on Twitter @Andrew.Grill on InstagramKeynote speeches hereAndrew's upcoming book

Tim & John welcome Dana Fischer, Director, Regulatory Strategy for Mitsubishi Electric, to the show to talk about the regulatory environment, heat pumps, and the what Mitsu is doing to help train and educate contractors.#appetiteforconstructionpodcast #appetiteforconstruction #mechanicalhub #plumbingperspective #construction #constructionindustry #supportthetrades #trades #plumbing #skilledtrades #residentialconstruction #commercialconstruction #industryforecast #2023forecast #heatpumps #governmentregulations #minisplits #vrf Subscribe to the Appetite for Construction podcast at any of your favorite streaming channels.

Rozhovor s Ondřejem Dusílkem, CEO Centrálního depozitáře cenných papírů o tom, co je centrální depozitář, jak funguje a k čemu slouží, jaký je rozdíl mezi centrálním depozitářem a clearing housem, jak probíhá vypořádání burzovních obchodů a proč je stále T+2, nebo jak nejjednodušeji zjistit, zda-li na vás náhodou nečekají akcie ještě z kuponové privatizace. Dozvíte se také, jak se vede evidence cenných papírů a k čemu slouží navazující evidence, co by se stalo, kdyby ČEZ odešel z BCPP nebo jak lze by šlo obchodovat Venator, Groupon nebo Plug Power na BCPP. BIO: Vystudoval Ekonomickou fakultu VŠB-TU Ostrava a to obor Finance (2003) a obor Eurospráva (2005). V roce 2016 ještě dokončil na University of London Diploma for graduates in Banking.  Svou profesní kariéru zahájil v roce 2005 jako analytik ve společnosti UNIVYC, a.s., což byla dceřiná firma BCPP,  která se v roce 2010 přejmenovala na Centrální depozitář cenných papír, a.s. a převzala evidence cenných papírů od SCP. V roce 2012 absolvoval stáž City of London Corporation, která zahrnovala také dvou měsíční pracovní zkušenost ve společnosti London Stock Exchange v oddělení Regulatory Strategy. Také se podílel v letech 2013 a 2014 jako poradce na projektu Světové banky s cílem modernizovat kapitálový trh v Azerbajdžánu. V roce 2017 byl zvolen do představenstva Centrálního depozitáře cenných papírů a o dva roky později byl jmenován generálním ředitelem centrálního depozitáře a také byl zvolen do burzovní komory (představenstva) Burzy cenných papírů Praha. V ROZHOVORU SE DOZVÍTE:Co je centrální depozitář a k čemu slouží, co zajišťuje (0:40)Co znamená nominee concept (6:03)Rozdíl mezi centrálním depozitářem a clearing housem (7:05)Jak probíhá margin call (10:36)Trendy v likviditě na BCPP (11:45)Jak probíhá vypořádání na energetické burze (12:35)Jaký je rozdíl mezi fyzickými a dematerializovanými akciemi (16:28)  Co znamená navazující evidence (20:36)Služby pro emitenty (LEI a ISIN indetifikátor) (23:08)Vypořádání burzovních obchodů (T+2) a proč to nelze zkrátit na T+1 (problé m s Gamestopem a Robinhoodem) (26:43) Komunikace s orgány veřejné moci a jak často komunikují s finančním úřadem  (33:01)Výpis z nezařazené evidence (700 000 účtů v nezařazené evidenci) (34:01)Nová technologie DLT (40:24)Emise dluhopisů a podpora Ministra financí (43:50)Čez na BCPP a co by se stalo, kdyby ČEZ z burzy odešel (48:40)Tržby CDCP (54:04)Venator, Groupon nebo Plug Power na BCPP (58:37)ZPĚTNÁ VAZBA:Vaše zpětná vazba je pro mě důležitá. Máte-li k podcastu jakékoliv poznámky, zašlete mi je, prosím, na lenka@schanova.com nebo na Twitteru @lenka_schanova. Děkuji.  DALŠÍ ROZHOVORY:Jiří Kovařík a Přemek Papp: IPO pohledem emitentaMichal Šnobr: Investiční aktivityDušan Šenkypl: Budování Pale Fire Capital, investice do Grouponu, prodej ePojis

In this regulatory wrap up from ESG Talk, host Mandi McReynolds is joined by her Workiva colleagues, Andromeda Wood, Vice President of Regulatory Strategy, and Steve Soter, Senior Industry Principal. Andie and Steve share their takes on ESG regulation in the EU and US, including CSRD and recent developments by the SEC.  Resources: 1) Andromeda Wood, CSRD Debrief - https://www.workiva.com/blog/csrd-debrief-whos-impacted-and-how-prepare  2) Steve Soter, podcast co-host Off the Books  https://podcasts.apple.com/us/podcast/off-the-books/id1505814699  3) COP27 and What's Next for ESG ft. Paul Dickinson, CDP - https://podcasts.apple.com/us/podcast/esg-talk/id1622905439?i=1000588129567  4) The ROI of Sustainability ft. Tensie Whelan, NYU Stern Center for Sustainable Business - https://podcasts.apple.com/us/podcast/esg-talk/id1622905439?i=1000585631997 

Our latest paper explores the key regulatory considerations across four key thematic areas: consumers, data, resilience, and governance and accountability, and how these will affect firms' strategies around embedded finance. In this episode, Suchitra Nair from the Centre for Regulatory Strategy and Richard Kibble, UK Banking Leader, discuss the current embedded finance landscape, the risks, opportunities and strategic considerations for firms. Our guests then offer some predictions for what they expect to see in the embedded finance market over the next 12-months.

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn't? Those are the questions that today's guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.Some of the highlights of this episode include:What regulatory strategy is and what it isn'tWhy a good regulatory strategy is so importantWhat competitive regulatory strategy isThe mistake of focusing on only one companyHow the EU MDR is affecting regulatory strategyWhat causes delays in complying with regulationsThe industry record on post-market surveillanceReimbursement and regulatory strategyMemorable quotes from Mike Drues:“Let's not forget my old friend, competitive regulatory strategy.”“It's never too soon, in my opinion, to start thinking about regulatory strategy.”“As a general rule, we have done an abysmal job on post-market surveillance across the board.”“I consider this whole thing to be a poker game, in every sense of the word.”Links:Mike Drues LinkedInHow to Construct an Effective Regulatory Strategy Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

At the end of February 2022, Commissioner for Data Protection, Helen Dixon, launched the Irish Data Protection Commission's Annual Report for 2021. At the launch of the report Ms Dixon commented: “2021 has been a year of strong regulatory results from the DPC, in which it delivered impactful and far-reaching outcomes for the protection of individuals' personal data. The GDPR is a strong framework law that demands accountability, fairness and transparency from all organisations that process personal data. It is clear that “data controllers” in Ireland continue to improve their compliance efforts, but higher standards of responsiveness to individuals seeking to exercise their rights are still needed in many sectors. The DPC will continue to target enforcement actions aimed at driving those necessary improvements, in addition to publishing decisions and case studies on its website to guide data controllers in the application of the GDPR. Operationalising the aims of the GDPR is an important work-in-progress for all of us and must continue.”   Steven Roberts, vice chair of the Compliance Institute's Data Protection & Information Security Working Group talks to Graham Doyle, Deputy Commissioner and Head of Corporate Affairs, Media and Communications with the DPC about implementing the DPC's 2022-2027 Regulatory Strategy, engaging with other Data Protection Authorities, developments around International Data Transfers, processing children's data plus, policies and fines.

In this episode we're speaking with Jim O'Sullivan, VP Regulatory Strategy and Special Projects at Matternet. In case you missed it, Matternet became the first commercial delivery drone manufacturer to receive type certification from the FAA in September 2022. This is an important industry milestone because, according to the FAA, operators that want to provide a regular commercial delivery service beyond visual line of sight need to run their operations under a Part 135 air carrier operating license…and this in turn requires type certified drones. So, we asked Jim to join us and talk about the drone type certification process: what it looks like, how long it took, all the twists and turns along the way, including the remaining challenge of certifying so called associated elements, meaning all parts of the drone system that do not fly, such as the ground control station and the datalink. We also talk about the commercial drone industry broadly: state of the market today and upcoming milestones. And for those of you thinking about starting a drone business, you'll want to hear Jim's advice. 

In this episode, Kamal has a conversation with fintech all-star Teana Baker Taylor, who has had past positions with Binance, Crypto.com, HSBC, Fiserv, and Citi. Teana now serves as Vice President of Policy and Regulatory Strategy for the EU and UK for Circle. Named the Regulatory & Governance Leader of the Year within the Women in Finance Awards 2020, recognized as one of the Standout 35 of the most influential women in Fintech globally within the Innovate Finance 2019 and 2018 Women in Fintech Powerlists and won the Blockchain Leaders category in the Women In Tech Awards 2019. Kamal Hubbard is a lawyer by training who is certified in Fraud Examination, Cybersecurity, and Decentralized Finance. Kamal spent two years conducting individual research on Bitcoin and blockchain technology before entering a position in cryptocurrencies. He is a civil rights officer; the founder of the blockchain consulting company, CageChain Media Group; and serves as an advisor to the Tao Network Blockchain. Mr. Hubbard is the author of the groundbreaking book DeFi for the Diaspora and had the privilege of testifying before California's Senate Banking Committee on the basics of blockchain and Bitcoin. Get your copy of #DeFi for the Diaspora at: http://www.kamalrhubbard.com/defi-for-the-diaspora-book/ Sign up for the free CageChain Newsletter at: http://www.cagechain.io Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode, Ti Benson and Duane Mancini discuss global regulatory strategy, the current landscape in the EU, MDSAP, hidden expenses, terminology, and so much more. Ti Benson LinkedIn LeanRAQA Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech. Duane has experience in go-to-market strategy, including regulatory and reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design and execution. He has developed a comprehensive understanding of what early-stage startups need to do to be successful.With all of the complexities of running a medtech company and taking a product to the market, Duane has seen a huge variation in how startups develop strategies and milestones. In this episode, we discuss how early decisions impact other aspects in the future and how companies can create a blueprint to build and grow long-term.Some of the highlights of this episode include:Fundraising: Figure out who you want to raise capital from, what should be in your pitch deck, and what questions will investors ask about problems/solutions.When trying to raise money, startups need to know that there are three types of investors—good, neutral, and bad. Sometimes, bad investors are hard to spot.When considering acquiring a company, some of the top things strategics look at is how you capture more clients, build your team, incorporate a quality management system (QMS), and handle regulatory challenges.If you are selling products to a hospital system, you will need to check three things—physician/clinician (especially nurses) ownership, patient improvement, and economic benefit.Build, develop, and invest in your team by finding people who complement your weaknesses. Don't be afraid to fractionalize. One of the most important thing you can do for your company is to find advisors, partners, and mentors with large professional networks.When people are raising money, unless you are raising from a high net worth individual or angel group, be strategic with who you want to raise money. Venture Capitalists have a responsibility to spend (invest) their money just like you have a responsibility to raise it.Clients need to understand that regulatory fits into their business, clinical, reimbursement, and commercialization strategies—all those things work together and overlap, so make sure to ask the right questions to the right expert.Memorable quotes from Duane Mancini:“The #1 thing we try to tell all of our startups when they're going out to raise money is there's three types of investors. There's good, neutral, and bad. You really want to avoid bad.”“For those first few investors, you want to find a good investor. Someone who's going to bring something else to the table. Fill a knowledge or network gap that you don't have. Understand what your mission is for the company and how they are going to support it.”“We talk to a lot of investors and a lot of entrepreneurs, and the one thing we've learned is that there is more than one way to raise money. However, there are patterns.” “Regulatory fits into your business strategy, fits into your clinical strategy, fits into your commercialization strategy—all those things work together and overlap.”Links:Duane Mancini on LinkedInProject MedtechProject Medtech PodcastEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - 510(k) ClearancesFDA - Premarket Approval (PMA)Build by Tony FadellGG AcademyMedTech NationGreenlight Guru

In this episode, Rob Packard and Duane Mancini discuss the current landscape of regulatory requirements in the EU, evolution of regulatory in the EU, the MDR, what is a notified body, post market surveillance in the US, global regulatory strategy, and so much more. Rob Packard LinkedIn Medical Device Academy Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

In this conversation, we will be speaking with Ian Springsteel, who is the Director of U.S. Regulatory Strategy at the National Grid. In this capacity, Ian develops and oversees regulatory strategy and implementation of new programs and petitions to U.S. regulators. His areas of focus include: electric vehicles and electrification of heat, solar incentive programs, grid modernization, and energy storage. In this conversation we discuss several of the programs he developed within those technology areas and also dive into what inspired Ian to get involved in the Energy Sector to begin with. Hope you enjoy my conversation with Mr. Ian Springsteel!

What is the best methodology for presenting your Company to investors, industry partners, and public funding organizations?Here is the answer: In this episode, Donna LaVoie presents her famous “15-slides-methodology” in great detail.Donna is a proven strategic communications leader in health and science innovation. She is a trusted advisor on strategic communications issues, especially around complex problems affecting multiple stakeholders. She brings a unique combination of public and investor relations expertise, including product launch experience.LaVoieHealthScience was launched in 2001 after a corporate career with signature biotech companies leading strategic communications functions during tremendous growth, product and business launches, and international geographic expansion.As an acknowledged leader in health science communications with public and investor platforms, LaVoieHealthScience is recognized as a top 30 independent healthcare agency in the US. The agency has received more than 35 awards for its client work. It is recognized by INC.5000 Hall of Fame – Fastest Growing Private Companies, Boston Business Journal's top Massachusetts PR firms, PharmaVOICE 100, and O'Dwyers.We are talking about:↪️ Why 15 slides are sufficient in corporate presentations↪️ Why you should have an Agenda slide↪️ Why an Appendix is important↪️ What is Better? Detail or Simplicity?↪️ The interplay of Problem and Solution↪️ Why the Team slide matters↪️ Why you need to adapt the presentation to your audience↪️ And much, much moreYoutube Video

In this episode, David Strachan and Suchitra Nair from the EMEA Centre for Regulatory Strategy discuss the major market developments that have shaped 2022 so far and what these are likely to mean for the regulation and supervision of financial services firms.

Putting The Stability Back Into Stablecoins In this episode of Public Key, our host, Ian Andrews (CMO at Chainalysis) is joined by Caroline Hill, Director of Global Policy and Regulatory Strategy, at Circle, who brings her 7+ years of US Treasury Department experience to discuss the regulatory regime around stablecoins, the impact of rushing to create CBDCs and Circle's ambition to be the most regulated stablecoin.  The conversation highlights that not all stablecoins are created equal and touches on the epic failure of the Terra LUNA stablecoin and how more transparency regarding reserves is needed. She also covers some of the exciting and innovative products coming out of Circle including Verite and the Euro stablecoin, EUROC.  Minute-by-minute episode breakdown (2:15) – Caroline's origin story going from detecting sanction evaders to innovative financial technologies helping with remittances (5:45) – Why the USA financial system is fine but far from being innovative leader (9:45) – Does international policy and regulation in crypto foster financial innovation  (14:11) – The stability behind USDC and the use case for stablecoins  (18:25) – Would CBDCs be a good idea for government, private sectors, traditional FIs and financial inclusion? (23:55) – Is China weaponizing their CBDC and making mitigating sanctions evasion more difficult  (25:00) –Not all stablecoins are stable and not all created equally  (28:15) – How digital identity can be privacy preserving yet meet AML requirements without creating vulnerable honeypots (30:10) – Conducting “follow the money” investigations with stablecoins  Related resources Check out more resources provided by Chainalysis that perfectly complement this episode of the Public Key. Report:The Chainalysis State of Web3 Report Webinar: The State of Web: Watch On Demand (with Ethan McMahon and Kim Grauer) Circle Blog: Circle Yield. Built Differently. Circle Blog: Reflections on Europe's Markets in Crypto-Assets Framework (MICA) Website: Verite: Decentralized identity for crypto finance Circle Blog:Circle's newest stablecoin, Euro Coin (EUROC) is here Circle Blog: Information about Circle's reserves and redemptions Speakers on today's episode Ian Andrews * Host * (Chief Marketing Officer, Chainalysis) https://www.linkedin.com/in/ianhandrews Caroline Hill (Director of Global Policy and Regulatory Strategy, Circle) https://www.linkedin.com/in/caroline-hill-4a1b7814 This website may contain links to third-party sites that are not under the control of Chainalysis, Inc. or its affiliates (collectively “Chainalysis”). Access to such information does not imply association with, endorsement of, approval of, or recommendation by Chainalysis of the site or its operators, and Chainalysis is not responsible for the products, services, or other content hosted therein. Our podcasts are for informational purposes only, and are not intended to provide legal, tax, financial, or investment advice. Listeners should consult their own advisors before making these types of decisions. Chainalysis has no responsibility or liability for any decision made or any other acts or omissions in connection with your use of this material. Chainalysis does not guarantee or warrant the accuracy, completeness, timeliness, suitability or validity of the information in any particular podcast and will not be responsible for any claim attributable to errors, omissions, or other inaccuracies of any part of such material.  Unless stated otherwise, reference to any specific product or entity does not constitute an endorsement or recommendation by Chainalysis. The views expressed by guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent. Views and opinions expressed by Chainalysis employees are those of the employees and do not necessarily reflect the views of the company.   

Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations and In Vitro Diagnostic Regulations. In fact, research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result and the complexity isn't limited to just our friends in Europe. The US, Australia, Canada, China, and many more countries are adapting their regulatory approach. The only thing that doesn't change is change itself - applies both in life and regulatory.  Today we're going deeper into how to modernize regulatory affairs, specifically for medtech. James Gianoutsos is the Founder & President of RimSys - a regulatory information management platform that centralizes regulatory activities in the cloud. From product documentation to streamlined submissions to monitoring market status, RimSys can save RA teams hours and hours. Any life sciences founder listening in can learn from James's experience jumping into entrepreneurship from his career in Quality/Regulatory and how to get to market faster utilizing digital technologies.  Enjoy!About James GiantoutsosJames Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James' professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.About RimsysRimsys was founded in 2017 by regulatory affairs professionals who asked the simple question: “Isn't there a better way to do this?” Like all RA teams, they spent hours looking for information, manually managed global product registrations, and struggled to keep up with changing regulations and standards. The Rimsys Platform is designed specifically to help medtech companies address these challenges, and confidently establish global regulatory compliance.Show noteshttps://www.rimsys.io/Rimsys Series A postJames Giantoutsos LinkedInQualio WebsitePrevious episodes: https://www.qualio.com/from-lab-to-launch-podcastApply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8Music by keldez

In a world where technology is evolving rapidly, and the volume of data that has to be managed is expanding exponentially, how do you maximize what it has to offer? Paul Attridge, VP Regulatory Strategy, shares insights on how people, processes, and data are influencing and impacting the business transformation.

Angel-scale biotech is exploding: Learn More Practicing urologist and founder Jeremy Wiygul, MD believes millions of people are suffering needlessly due to the inadequate delivery of effective treatment, among these his own wife. Pelex aims to use new technology to integrate existing resources and greatly enhance patient outcomes for people with pelvic floor problems such as incontinence. A fun chat with a compelling founder. Sponsors: Purdue University entrepreneurship and Peter Fasse, patent attorney at Fish & Richardson Highlights: Sal Daher Introduces Jeremy Wiygul, MD Founder of Pelex “...up to 60 million Americans are affected by one form or another of pelvic floor disorders.” Pelex Combines a Connected Device and a Telehealth Platform to Provide Effective Care Pelex Intends to Bring Together the Right Provider, the Right Treatment and the Right Delivery of Care Consumer-Grade Pelvic Floor Devices Are Hit or Miss Parallels to Imago Rehab Which Delivers Physical Therapy Remotely via a Connected Device Connected with Jeremy Wiygul via Chrissy Glover of Imago Rehab Jeremy Wiygul's Own Physical Rehab Informs His Work Why Would a Urologist with a Practice in New Your City Found a Startup? What's the Innovation Pelex Is Bringing to Market? The Regulatory Strategy to Build Value in the Long Run “...we feel very strongly that our outcomes are going to be above, and significantly better than any other service that's out there.” Strategy with Regards to Intellectual Property The Combination of Practitioner, Care and Delivery Has the Potential to Build a Brand Based on Dramatic Improvements in Outcomes for Patients If the Wife of an Urologist Struggles to Get the Right Care in Her Husband's Specialty, There's Obviously a Problem Contact jeremy@pelex-med.com if You Have the Problem or Want to Help Exit Strategy The Power of Bringing the Right Technology to Market at the Right Time Learn More at https://pelexhealth.com/ Thanks Chrissy Glover of Imago Rehab for the Introduction to Jeremy Wiygul Topics: biotech, discovering entrepreneurship, software

On this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss: Why he enjoys working with Startups Reimbursement considerations for Startups Importance of Regulatory Strategy for Startups Project Medtech and Medtech Money Podcasts Startup Symposiums Combination Products Startups Startup Symposium in Columbus, OH on 15-Jun-2022 - Register here Book Recommendation: Your Life Depends on It: What You can do to make better choices about your health Link ------------------------------------------------------------------------------------------------------------------------------------------------------ Duane Mancini is a chemist by training and holds a Master of Science degree in Medicinal Chemistry from the University of Toledo.  He started his medical device career at NAMSA as a technical advisor who specialized in overall biological safety planning including the use of chemical characterization to reduce the amount of biocompatibility testing needed for approval. He then moved into a senior technical advisor role at NAMSA and worked with clients on regulatory, reimbursement, and clinical strategies.  This unique and end-to-end background enabled him to be chosen to help lead NAMSA's MRO team.  In this role, he applied the NAMSA MRO approach (end to end CRO services) to medical device companies in order to accelerate time to market.  This role required working with mostly medical device start-up companies in developing and executing a get-to-market strategy. Duane then worked for Labcorp on the Medical Device and Diagnostic team as a Business Development Director bringing regulatory, reimbursement, pre-clinical and clinical support to his Medtech clients. He is currently the CEO and Managing Partner of Project Medtech.  Project Medtech is a media and advisory firm that is committed to supporting the delivery and development of innovative medical technology.

COP26 highlighted the critical role business and finance will play in driving the transition to a net zero economy. Businesses made new net zero commitments; regulators discussed how to tighten scrutiny of those commitments; and policy makers announced plans to mandate the publication of climate-related risks to business. So how can finance best help the transition to net zero? What can be done to prevent ‘greenwashing' and build trust in businesses' commitment to tackling climate change? And what does government need to do to support green business and finance? With the UK set to continue to play a leading role on green finance, our panel discussed discuss how it can accelerate progress after COP26: Sarah Breeden, Executive Director, Financial Stability Strategy at the Bank of England Anthony Browne MP, member of the Treasury Committee Maria Lombardo, Head of ESG Advisory Sustainable Finance at Standard Chartered Bank Kuangyi Wei, Director, Risk & Regulatory Strategy, UKI at Accenture The event was chaired by Tom Sasse, Associate Director at the Institute for Government. #IfGnetzero We would like to thank Accenture for kindly supporting this event.

In the weeks since the invasion of Ukraine, the US and others have levied heavy sanctions against Russia. Financial businesses, including crypto firms, are now expected to comply with regulations by blocking a growing number of sanctioned entities. Some businesses, like PayPal and Revolut, have chosen to block Russian users altogether, despite this not being a requirement under the current sanctions regime. Others, like Kraken, have made it clear that while they block all sanctioned entities, they will continue to serve Russian users until political forces definitively direct them to stop. And still others, like FTX, have chosen to cut off some Russian accounts that aren't on the sanction list in addition to the sanctioned entities but continue to serve most Russian users. The varying approaches to sanctions compliance have left some wondering where the lines are, both legally and ethically. Meanwhile, some lawmakers are floating proposals to empower the Treasury to bar crypto services providers from transacting with any addresses associated with Russia.  In this week's episode of Policy Scoop, The Block's Aislinn Keely sits down with a sanctions expert and the legal chiefs from Kraken and FTX to parse out the complexities around Russian sanctions and the impact on the crypto industry as it stands today. Episode 24 of Season 4 of The Scoop was recorded remotely with The Block's Aislinn Keely and Marco Santori, CLO at Kraken, Caroline Brown, former White House sanctions attorney at Crowell & Moring, & Mark Wetjen, Head of Policy and Regulatory Strategy at FTX.US. Listen below, and subscribe to The Scoop on Apple, Spotify, Google Podcasts, Stitcher or wherever you listen to podcasts. Email feedback and revision requests to podcast@theblockcrypto.com. This episode is brought to you by our sponsors Fireblocks, Coinbase Prime & Chainalysis Fireblocks is an enterprise-grade platform delivering a secure infrastructure for moving, storing, and issuing digital assets. Fireblocks enables exchanges, lending desks, custodians, banks, trading desks, and hedge funds to securely scale digital asset operations through the Fireblocks Network and MPC-based Wallet Infrastructure. Fireblocks serves over 725 financial institutions, has secured the transfer of over $1.5 trillion in digital assets, and has a unique insurance policy that covers assets in storage & transit. For more information, please visit www.fireblocks.com. About Coinbase Prime Coinbase Prime is an integrated solution that provides institutional investors with an advanced trading platform, secure custody, and prime services to manage all their crypto assets in one place. Coinbase Prime fully integrates crypto trading and custody on a single platform, and gives clients the best all-in pricing in their network using their proprietary Smart Order Router and algorithmic execution. For more information, visit www.coinbase.com/prime. About Chainalysis Chainalysis is the blockchain data platform. We provide data, software, services, and research to government agencies, exchanges, financial institutions, and insurance and cybersecurity companies in over 60 countries. Our data powers investigation, compliance, and market intelligence software that has been used to solve some of the world's most high-profile criminal cases and grow consumer access to cryptocurrency safely. Backed by Accel, Addition, Benchmark, Coatue, Paradigm, Ribbit, and other leading firms in venture capital, Chainalysis builds trust in blockchains to promote more financial freedom with less risk. For more information, visit www.chainalysis.com.

COP26 highlighted the critical role business and finance will play in driving the transition to a net zero economy. Businesses made new net zero commitments; regulators discussed how to tighten scrutiny of those commitments; and policy makers announced plans to mandate the publication of climate-related risks to business. So how can finance best help the transition to net zero? What can be done to prevent ‘greenwashing' and build trust in businesses' commitment to tackling climate change? And what does government need to do to support green business and finance? With the UK set to continue to play a leading role on green finance, our panel discussed how it can accelerate progress after COP26: Sarah Breeden, Executive Director, Financial Stability Strategy at the Bank of England Anthony Browne MP, member of the Treasury Committee Maria Lombardo, Head of ESG Advisory Sustainable Finance at Standard Chartered Bank Kuangyi Wei, Director, Risk & Regulatory Strategy, UKI at Accenture The event was chaired by Tom Sasse, Associate Director at the Institute for Government. #IfGnetzero We would like to thank Accenture for kindly supporting this event.

In this episode, our guest Isabella Schmitt and Duane Mancini discuss the rapid growth Proxima has seen in the last 5 years, the new accelerator she founded called M1 Accelerator, the importance of regulatory strategy, why one might choose a de novo vs. 510k, why startups shouldn't be afraid of a PMA, implementing regulatory strategy into your business strategy, the common mistakes Isabella sees with startups, her best advice for startups and so much more. Isabella Schmitt LinkedIn Proxima CRO Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, CRDP researcher Whitney Oachs discusses her new research examining the issues, barriers and opportunities facing rural energy providers in shifting their infrastructure to renewable sources. She is joined by Tim Velde, who sits on the Board of Directors for the Minnesota Valley Cooperative Light & Power Association as well as on the Board of Directors for the Minnesota Rural Electric Association. She is also joined by Jennifer Cady who is the Manager of Regulatory Strategy & Policy for Minnesota Power.

Welcome to episode 93 of the FTX Podcast with special guest Mark Wetjen and your host Tristan Yver.Mark now joins FTX US as Head of Policy and Regulatory Strategy; bringing with him more than twenty years of experience in the practice of law, policy making, regulatory strategy and exchange operations. He most recently held the position of CEO at MIAX Futures, where he focused on crypto-derivative products and strategic initiatives. Mark also previously served as a commissioner and acting chairman of the U.S. Commodity Futures Trading Commission (CFTC) and was a member of the board of directors at LedgerX.Thank you for your time, energy & insight Mark!

In this episode, Michelle and Duane discuss discuss her focus on startups, when to get a regulatory strategy done, why regulatory strategy is crucial and should be a part of your business plan, why you need to be careful when building your website, when it makes sense to use a stepwise regulatory approach, benefits to a De Novo pathway, could the US move towards MDRish regulations, and more. Michelle Lott LinkedIn LeanRAQA Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

This week, we're joined by Jaspreet Grewal & Sabrina Ramkellawan, founders of Knowde Group - Canadian contract research organisation and hybrid consultancy specialising in plant-based therapeutics and psychedelics.In this episode, we explore the complexities of clinical trials within the cannabis industry, including barriers to entry, the three phases of clinical trials, how to navigate the regulatory landscape, and access to funding.About Jaspreet Grewal  MBA, MSc, CCRPJaspreet Grewal is an accomplished clinician, researcher and venture partner bringing over 15 years of experience to companies focused on the Life Sciences. Throughout her career, she has held various positions with increasing responsibilities in various healthcare roles resulting in a broad skillset and robust healthcare and investment network while working in Canada, the US, the UK, the Cayman Islands, and Bermuda. Jaspreet holds a Master's in Clinical Vision Sciences from Georgetown University, an Executive Certificate in Public Health from Harvard University and an MBA from the London School of Economics and Political Science.She is considered an expert in Healthcare and Regulatory Strategy and is a passionate advocate for building Alberta's Life Science ecosystem. She has successfully merged her expertise in innovation, research and finance to become a dynamic leader not only nationally but internationally. Her current roles and affiliations include:Co-Founder & CEO, Knowde Group (Canada, UK and Australia)Founder & CEO, Venn Consulting (Canada)Board Director, BioAlbertaEntrepreneur in Residence, Innovate Calgary (Medical Cannabis)Global Lifesciences Consultant, Calgary Economic DevelopmentExternal Advisor to the Vi Riddell Pain & Rehabilitation Centre, Alberta Children's Hospital  About Sabrina RamkellawanSabrina has over 20 years of clinical research experience in pharma, medical devices, natural health products and plant-based therapeutics including cannabinoids. She has held positions at or advised some top pharmaceutical, cannabis, psychedelic, and research companies. Sabrina has conducted and supported 11 cannabis research studies to date. She has previous experience leading operations at large scale global Contract Research Organisations including INC Research (now Syneos Health) as well as building successful speciality clinics. Sabrina is also passionate about education and has helped to build and currently teaches the first Certified Cannabis Educator Program at Michener Institute of Education at UHN. She has been and continues to be a speaker in the area of research and plant-based medicine. Prior to her role at Knowde Group, she was the VP of Clinical Affairs at TerrAscend Canada which is a licensed producer. In her role as Chief Operating Officer at Knowde Group, she is focused on all aspects of conducting research specialising in plant-based therapeutics and psychedelics. ResourcesJoin Sabrina on LinkedIn: https://www.linkedin.com/in/sabrinaramkellawan/?originalSubdomain=caJoin Jaspreet on LinkedIn: https://www.linkedin.com/in/jkgrewal/Follow Knowde Group on Twitter: https://twitter.com/knowdegroupKnowde Group's Website: https://www.knowdegroup.com/ 

At the start of 2021, we identified nine regulatory themes affecting the financial services industry as a consequence of the COVID-19 pandemic. Against a more optimistic economic outlook than anticipated, Orla Hurst revisits these themes with David Strachan and Suchitra Nair from the EMEA Centre for Regulatory Strategy – identifying the developments and actions firms should focus on for the remainder of the year. Tune in now! Key questions: What is the risk of credit risk deteriorating in the second half of the year? And how can firms stay on top of it? What do firms need to keep an eye on from a customer and conduct perspective? What are some of the challenges to regulators and firms regarding cryptocurrency? What does regulatory divergence between the UK and EU mean for firms? And how can they best manage it?   The speakers are David Strachan, Suchitra Nair and Orla Hurst.    

Suzanne calls Patrick Tigue, the Health Insurance Commissioner for the State of Rhode Island, to discuss the Office of the Health Insurance Commissioner (OHIC)'s initiatives to stem health care cost growth in RI. Rhode Island has established a cost growth benchmarking process to bring greater transparency to the market. They've also created a first-in-the-nation initiative that caps annual growth in prices paid by commercial health plans. Patrick and Suzanne chat about the impacts these programs have had on the market, and what may be ahead for Rhode Island and other states that follow its lead.

Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped promote her product both to investors and distributors around the globe.

Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped promote her product both to investors and distributors around the globe.

Darshan is the Principal Attorney of the Kulkarni Law Firm, and focuses his practice on providing life science, healthcare and healthtech companies with comprehensive regulatory advice. Darshan has worked at multiple Venture Capital backed in-house positions, and started multiple legal departments including at Embedded Healthcare, LLC where he served as General Counsel and Chief Compliance Officer and as Corporate Counsel for Nostrum Pharmaceuticals where he was responsible for and oversaw multiple legal and compliance matters including issues relating to advertising, clinical research, and creating and reviewing a variety of agreements including NDAs, MSAs, CDAs, employment agreements, and licensing agreements. He has created multiple compliance programs including addressing issues relating to the False Claims Act, Anti-Kickback Law, HIPAA, HITRUST issues etc. Most recently, he has also served as Vice President of Regulatory Strategy and Policy at Synchrogenix, another Venture Capital backed global consulting company. He has spent over 20 years counseling clients on regulatory issues, and has served as a pharmacist for over a decade.Darshan has also written several book chapters on regulatory compliance for various publications on behalf of the American Bar Association where he is Chair of the Life Sciences Interest Group. In this episode, we discuss parsing the biotech enigma. Why is there a boom in biotech right now? What is patient centricity and does it matter in the biosciences? Is transparency the cure to the lack of trust in the biosciences? What is biohacking and is it the future of bioscience?

You don’t need to be an expert in financial services to know that innovation has been rapidly changing the way we make payments. Significant technological and infrastructural changes are enabling businesses and consumers to transact with increasing ease. But what are some of the regulatory challenges that this change gives rise to? In this episode, we speak to David Myers, Deloitte’s Payments Lead, and Valeria Gallo from the EMEA Centre for Regulatory Strategy to hear what lies ahead for the payments industry. Tune in now!   Key questions: What are the six major trends driving innovation in the payments landscape right now? How do regulators approach the risk of an increasingly complex payments value chain?  How do cryptocurrencies and distributed-ledger technologies change the way that payments are likely to evolve? What should financial services firms be doing now to prepare for this change?       

Genetic Engineering and Society Center GES Colloquium - Tuesdays 12-1PM (via Zoom) NC State University | http://go.ncsu.edu/ges-colloquium GES Mediasite - See videos, full abstracts, speaker bios, and slides https://go.ncsu.edu/ges-mediasite Twitter - https://twitter.com/GESCenterNCSU Overview of Pairwise and their mission to build a healthier world through better fruits and vegetables by bringing new varieties to consumers. Insights into using gene-editing to make healthy produce a more attractive choice, and some of the regulatory considerations. Related: Pairwise – pairwise.com Guest Speakers Dan Jenkins has 20+ years’ experience working in the food and agriculture industry and serves as the Regulatory Strategy and Quality Lead for Pairwise. Prior to this Dan was the Managing Director and Chief of Staff of the Agricultural Section of the Biotechnology Innovation Organization (BIO) trade association in Washington DC. Dan also lead Monsanto’s Regulatory team in Washington DC overseeing all domestic chemistry and biotech crop approvals across FDA, EPA and USDA, and at the beginning of his career, worked in pesticide commercial sales, as well as R&D, for Dow AgroSciences. Dan earned a Bachelor of Science in Biology from Cal Poly San Luis Obispo, a Master of Science degree in Entomology and Applied Ecology from the University of Delaware and his Juris Doctor from Loyola Law School. GES Center - Integrating scientific knowledge & diverse public values in shaping the futures of biotechnology. Find out more at https://ges-center-lectures-ncsu.pinecast.co

Hosted by Samir Agarwal https://www.wolterskluwer.com/en/experts/samir-agarwal and special guest Tim Burniston https://www.linkedin.com/in/timothy-burniston-94682550/Episode Summary:Wolters Kluwer® is a market-leading provider of advisory services and technology solutions for optimizing compliance and risk management programs. Banking Compliance Insights is a podcast series created to deliver insights on compliance trends and provide strategies for navigating today's regulatory and risk environments.Is your financial institution prepared for 2021's regulatory compliance changes?In our new podcast, "Consumer Compliance: Shift Priorities to Follow Changes in Regulatory Oversight Trends," we focus on adapting to current and expected regulatory priorities and oversight measures.Wolters Kluwer Vice President of Banking Compliance Solutions, Samir Agarwal, is joined by Tim Burniston, Senior Advisor, Regulatory Strategy with Wolters Kluwer, to offer guidance on fortifying compliance measures to prepare for the residual consumer impact of the pandemic, leadership changes in Washington, and an anticipated increase in regulatory change.Subscribe:iTunes/Apple Podcast: https://apple.co/33qiJN8RSS: https://bit.ly/36tYZdAGoogle Podcast: https://bit.ly/3jr6ohoSpotify: https://spoti.fi/3l9oOU8Product Highlights from the Podcast:• Wolters Kluwer Advisory Services https://bit.ly/3qTpmzZ• Wiz® Suite (Fair Lending Wiz, CRA Wiz, HMDA Wiz, CD BBE) https://bit.ly/3rVI8YO• Wolters Kluwer OneSumX® for Regulatory Change Management https://bit.ly/2OsBcUQWant customized compliance strategies? Sign up for a custom demo here. https://bit.ly/2Te4gxWListen to more Banking Compliance Insights by Wolters Kluwer here. https://bit.ly/2G8FlsoWhere else can you find Wolters Kluwer Financial Services on social media?• Facebook: @WoltersKluwerFinancialServices• Twitter: @WoltersKluwerFS• LinkedIn: https://www.linkedin.com/company/wolterskluwerfs/BUSINESS INQUIRIES If you have a question about how we can assist your financial institution with preparing for 2021's regulatory compliance changes, please post them in the comments section of this podcast! For more information and additional guidance, please visit www.WoltersKluwer.com or call 1-800-397-2341.DISCLAIMER: The information and views outlined in this Wolters Kluwer Financial Services' communication are general in nature and are not intended as legal or professional advice. Although based on the law and information available as of the date of publication, general assumptions have been made by Wolters Kluwer Financial Services that may not takeinto account potentially important considerations to specific businesses. Therefore, the views and information presented in Wolters Kluwer Financial Services' communication may not be appropriate for you. Readers must also independently analyze and consider the consequences of subsequent developments and/or other events. Readers must always make their determinations in light of their specific circumstances.#consultingservices #advisoryservices #covid #pandemic #risk #customercare #businessoperations #operations#univest #insights #policy #politcs #bankingcomplianceinsights #insights #podcast digitalbanking #wolterskluwer #whenyouhavetoberight #compliance #SamirAgarwal #TimBurniston

In this week's episode ACOI President, Kathy Jacobs, speaks with MB Donnelly, Assistant Commissioner at the Irish Data Protection Commission, as Head of Communications, Regulatory Strategy, EU Projects and DPO Networks, about what it takes to put together the Data Protection Commission Annual Report and what everyone should take from it.

Lynne Georgopoulos, VP Regulatory Strategy, Certara describes the company's platform to optimize pediatric drug development using biosimulation.  With an eye on pediatric diseases, Certara is employing modeling and simulation to determine how a drug developed for adults may be metabolized in children, including neonates. They are also operationalizing clinical trials to be more efficient and potentially less invasive which is important when working with young children. @certara #biosimulation #RACEforChildren #rarediseases #pediatriconcology Certara.com Listen to the podcast here

Lynne Georgopoulos, VP Regulatory Strategy, Certara describes the company's platform to optimize pediatric drug development using biosimulation.  With an eye on pediatric diseases, Certara is employing modeling and simulation to determine how a drug developed for adults may be metabolized in children, including neonates. They are also operationalizing clinical trials to be more efficient and potentially less invasive which is important when working with young children. @certara #biosimulation #RACEforChildren #rarediseases #pediatriconcology Certara.com Download the transcript here

Today's Guest is Seth Carmody, VP of Regulatory Strategy at MedCrypt. In this episode, Seth discusses his role at MedCrypt and their mission to make security easier for medical device manufacturers, medical-related security issues, his career journey and work at the FDA, what product manufacturers need to consider, and his toughest lessons learned. Additionally, Joe and Seth engage in a great discussion around what policy can do versus what industry ought to do.

This episode features Lynne Georgopoulos, NP & Vice President of Regulatory Strategy at Certara. Here, she joins the podcast to share with us her insights on pediatric drug development. She touches on the history of pediatric drug regulations, current challenges, upcoming projects and more!This episode is sponsored by Certara.

Lynne Georgopoulos, NP, Vice President of Regulatory Strategy at Certara, joins the podcast to share with us her insights on pediatric drug development. She touches on the history of pediatric drug regulations, current challenges, upcoming projects and more!  Sponsored by Certara

What will this New Year hold for the world of financial services regulation and supervision? How will COVID-19 affect the work that regulators are doing and what are the trends we see emerging as the pandemic recedes? In this special episode, Scott Martin is joined by Andrew Bulley and David Strachan from the EMEA Centre for Regulatory Strategy to hear their thoughts on the year ahead. From sustainability to credit risk, operational resilience to regulatory divergence, there’s a lot to cover. So join us! Questions: What aspects of the financial services regulatory framework are seen to have worked well or less well during COVID-19? How can firms handle the tension between prudential and conduct risks as they manage the challenges faced by their customers during the pandemic? What progress do we see being made on the sustainability agenda in 2021? What has COVID-19 taught the financial sector about managing its operational resilience? How can the financial sector continue to be seen as being ‘part of the solution’ in responding to the pandemic’s economic and financial challenges?    

Regulators, central banks and governments have taken unprecedented measures to support the economy during population lockdowns around the world to stamp out the spread of the Covid-19 pandemic. Prudential regulators have also acted quickly to ensure banks help support the economy. This has involved measures ranging from payment holidays on some loans, to delayed reporting through to pushing back some regulatory implementation deadlines and even temporary relaxations of some capital requirements. But are these measures temporary or do they signal a new trend where individual jurisdictions diverge from the bits of the Basel framework they don't like? In this series, Michael McKee, a partner at global law firm DLA Piper and David Strachan, the head of EMEA Centre for Regulatory Strategy at global consultancy Deloitte, have shared some insights as to how these trends might play out. See acast.com/privacy for privacy and opt-out information.

In this twin-episode, Gerard and Laurent explore the multifaceted aspects of the Digitization of the Grid. We suggest our listeners to consider the two Episodes as a whole, as we conclude the conversation at the end of Episode 27.We have had the privilege to welcome two great guests, Marcel Steinbach (E26) and Baard Eilertsen (E27). Their totally different vision and approaches - the Insider and the Disruptor - provide nevertheless a clear path towards full Digitization, one of the 3 D’s of the Energy Transition alongside Decentralisation and Decarbonisation. Episode 26 examine digitization through the lens of Power trading: Marcel Steinbach is Head of Energy Market Design and Regulatory Strategy at BDEW, the German Energy Association. BDEW is instrumental in shaping and structuring Energy markets, at the German and European levels. After 20 years of gradual but relentless improvements, the German power market has become one of the most liquid in the world while being totally decentralized. Marcel dives into the interactions and iterations of advanced digitization and energy trading, successfully facing the challenge of integrating up to 70% of renewables in the German grid.

What is a regulatory strategy? What are the components involved? In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy. Some of the highlights of the show include: • Pro Tip: Regulatory strategy is not synonymous with Pathway to Market (element), or 510(k) and De Novo (tactics). • Regulatory Strategy Executive Summary: Living artifact that serves as a communication tool to articulate pros, cons, benefits, risks, and options. • Executive Summary components may include device description, labeling matrix, classification and risk, and potential pathways to market. • Investor Pitch Deck: Demonstrate medical device idea by knowing all options, and possessing knowledge and experience of fluid and dynamic environment. • Conventional Wisdom: Easiest, fastest, cheapest path to market to get through regulatory challenges doesn’t always make sense for products and technology. • Future Features List: What do you want added to a medical device in the future? Start with the ultimate end in mind and work backwards to build strategy and plan. • Product Development Process: Bring in regulatory sooner than later, earlier the better. Changes after a design freeze are difficult, time consuming, and costly. • Summary, Recommendations, and Takeaways: Who is your audience? Will they understand the purpose? Offer proof.

As much of the world prepares for long periods of lockdown and social distancing, how can financial services firms and their regulators be confident that measures taken to strengthen the resilience of the financial the system have been enough? In this episode, Scott Martin speaks to David Strachan from Deloitte’s EMEA Centre for Regulatory Strategy and Rick Cudworth from Deloitte’s Reputation, Crisis & Resilience practice to get their take on whether the financial sector can stay resilient through the disruption caused by COVID-19. Tune in now to hear what we’re seeing during these extraordinary times. Key questions: How does the current turmoil in financial markets compare to the 2008-2009 global financial crisis? What can stress testing exercises tell us about the ability of financial sector firms to absorb the shock of COVID-19? How are regulators around the world trying to support the stability and functioning of financial firms? What should firms do to safeguard their operational resilience over the duration of the lockdown? What could changes in government strategy towards social distancing mean for firms in the coming months?

How do we deal with a challenge as difficult as cultural change in the financial sector? More than ten years on since the financial crisis, what’s still on the agenda of financial authorities? In this packed episode, Scott Martin speaks to Andrew Bulley and Orla Hurst from the Centre for Regulatory Strategy, as well as Rose-Marie Kennedy from Deloitte Ireland. Tune in now to find out what they see as the four most up-and-coming trends in financial services culture and what FS firms can expect to happen next. What are the most important trends in the approach of supervisors to culture in the financial sector? What jurisdictions are we supervisors seeing take a renewed interest in culture? What has been the recent experience of UK and Irish firms in addressing their culture? What is ‘psychological safety’ and what does it have to do with instilling a culture of challenge in a firm? What effect will technological trends like the digitalisation of banking have on firm culture outcomes?

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must keep in mind are related to the path to market, but have you ever thought about competitive regulatory strategy? Going with the PMA approach might be a better business strategy than using the 510(k), despite the entrenched mentality that it's a longer, more difficult road. Today we're going to talk to regulatory guru, Mike Drues. Mike is the president of Vascular Sciences and he is well-versed on the entire process medical device companies go through to get their products on the market. He's going to share his insight on competitive regulatory strategy and how it can help you make good business decisions. Some of the highlights of the show include: ● The pitfall of seeing the regulatory process only as a matter of jumping through hoops and the importance of seeing the bigger picture. ● What regulatory strategy is and how it differs from the path to market. ● How competitive regulatory strategy differs from regular regulatory strategy and how you can use it to your advantage. ● Some potential objections to using the PMA and how Mike responds. ● Thoughts on how to use guidance documents as a competitive weapon. ● Why one might consider a de novo classification as part of their regulatory strategy. ● Why you should always be looking for a different, better way to get through the regulatory process.

Welcome to Compliance Dos & Don’ts, where experts share their licensing and compliance knowledge.  Christa Rapoport, Senior Vice President for Regulatory Strategy and Compliance at Nelson Taplin Goldwater, returns to share her dos and don’ts for producer due diligence.  Her secret for success: Create a form that expressly states who the insurer is, who at a company and/or state regulator provided information about their authorization, whether the specific product is filed or exempt, and in which states that product can and cannot be offered, etc.  (This is especially important for innovative products.) And if you only learn one thing from this podcast, let it be this: The responsibility for verifying that an insurer is authorized to offer a specific insurance product in a state lies with the producer.

In this podcast, RAPS Senior Editor Pam Jones talks with RAPS President Glenn N. Byrd, MBA, RAC about the role of regulatory strategy and the regulatory strategist in the global biopharma industry. Byrd is principal consultant of GByrd Ad-Promo Solutions, LLC, recently retired from AstraZeneca as senior director, promotional regulatory affairs and spent 10 years with FDA.

Welcome to Compliance Dos & Don’ts, where experts share their licensing and compliance knowledge.  Christa Rapoport, Senior Vice President for Regulatory Strategy and Compliance at Nelson Taplin Goldwater, shares her dos and don’ts for producer compensation.  Her secret for success: The change from agent and broker licenses to a single producer license didn’t change the underlying laws and regulations governing compensation.  Know what your role in a transaction is. And if you only learn one thing from this podcast, let it be this: Be transparent; fully disclose to the consumer what services you are being compensated for and who provides that compensation.

Hello 2019, we’re ready for you. In our second episode, our host, Scott Martin is joined by David Strachan and Andrew Bulley from our EMEA Centre for Regulatory Strategy to discuss what’s on the financial regulatory agenda for the year ahead. From cyber to climate change, we explore some of the big risks and opportunities the financial industry will face in 2019. Let’s get straight into it!

Welcome to Regulated Radio! To kick things off we talk about two of the big issues in the massive shorefront of challenges that regulators and the financial sector are facing today namely just how much of an impact we think the Basel III agreement will have on European banks and what keeps European policymakers up at night when they think about the risks from cryptocurrencies. Scott Martin, our host, is joined by two guests from Deloitte's EMEA Centre for Regulatory Strategy, Rod Hardcastle and Suchitra Nair.

Joining us on the topic of Transparency is Mr. Darshan Kulkarni. Darshan is the VP of Regulatory Strategy & Policy at Synchrogenix, a globally recognized organization that provides regulatory and communications strategy, science, and other solutions to life sciences organizations. There aren’t too many individuals who are as well educated as Darshan. He holds his Doctor of Pharmacy degree from the University of Sciences in Philadelphia and both his Law Degree and Masters in Pharmaceutical Quality Assurance and Regulatory Affairs from Temple University. Darshan, a practitioner of pharmacy for almost 20 years, is often called upon to be a Keynote Speaker at several major conferences across the US. He has also written several text book chapters used today in the areas of pharmacy compounding, drug advertising, medical devices and drug reimbursement. Some key points we cover during this episode: 1. How do you define transparency? 2. Is transparency a burden? 3. Is there truly a need for transparency?

Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. It is an instance of the wider phenomenon of telemedicine, as implemented in the field of pharmacy. Darshan Kulkarni, host of the Gavel & Pestle Podcast and VP Regulatory Strategy & Policy with Synchrogenix interviews Timothy Youkhana President with Scaled Enterprise Solutions about telepharmacy opportunities for pharmacy business.  Telepharmacy services include drug therapy monitoring, patient counseling, prior authorization and refill authorization for prescription drugs, and monitoring of formulary compliance with the aid of teleconferencing or videoconferencing. Remote dispensing of medications by automated packaging and labeling systems can also be thought of as an instance of telepharmacy. Telepharmacy services can be delivered at retail pharmacy sites or through hospitals, nursing homes, or other medical care facilities. The term can also refer to the use of videoconferencing in pharmacy for other purposes, such as providing education, training, and management services to pharmacists and pharmacy staff remotely. ABOUT --Scaled Enterprise Solutions https://ses.healthcare/about/  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Welcome to the 5th annual Mobile in Clinical Trials podcast. In this quick fire podcast, you will get a brief overview on what to expect. The conference takes place in Boston on Sept 24th, the day before DPharm. It is researched and produced by the Conference Forum and is chaired by:  Daniel Karlin, MD Assistant Professor of Psychiatry, Tufts University and Former Head of Clinical, Informatics, and Regulatory Strategy, Digital Medicine, Pfizer Inc Mobile and digital tools are the future of clinical trials and as the industry continues to transition into a data science industry with a responsibility to reduce patient burden, it is really important that we bring this conference to you to get the latest examples on what tools are available and who has used them and what are the lessons to engage patients? For more information, visit www.theconferenceforum.org Producers: Valerie Bowling, Executive Director, the Conference Forum and Jennifer Moran, Producer, the Conference Forum        

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must keep in mind are related to the path to market, but have you ever thought about competitive regulatory strategy? Going with the PMA approach might be a better business strategy than using the 510(k), despite the entrenched mentality that it’s a longer, more difficult road. Today we’re going to talk to regulatory guru, Mike Drues. Mike is the president of Vascular Sciences and he is well-versed on the entire process medical device companies go through to get their products on the market. He’s going to share his insight on competitive regulatory strategy and how it can help you make good business decisions. Some of the highlights of the show include: ● The pitfall of seeing the regulatory process only as a matter of jumping through hoops and the importance of seeing the bigger picture. ● What regulatory strategy is and how it differs from the path to market. ● How competitive regulatory strategy differs from regular regulatory strategy and how you can use it to your advantage. ● Some potential objections to using the PMA and how Mike responds. ● Thoughts on how to use guidance documents as a competitive weapon. ● Why one might consider a de novo classification as part of their regulatory strategy. ● Why you should always be looking for a different, better way to get through the regulatory process.