Podcasts about global regulatory affairs

This panel was recorded 20 March 2025.⁠⁠⁠ Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the⁠ Knowledge Center⁠ at RQMplus.com.Women's health is finally getting the attention it deserves, yet progress is still slowed by gaps in clinical trial diversity, complex regulatory pathways, and funding challenges.In this RQM+ Live! panel discussion, industry leaders and regulatory experts will share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations to market.Why listen:Unlock Market Opportunities – Women's health is one of the fastest-growing MedTech sectors, with rising investor interest and funding.Gain Regulatory Insights – Understand how evolving regulations impact clinical trials, approvals, and commercialization.Learn from Real-World Success – Hear how industry leaders are overcoming challenges and making an impact.Ask Your Toughest Questions – Engage directly with panelists during the live Q&A.Bring Innovations to Market – Get expert insights on bridging clinical research, regulatory approval, and commercialization.Discussion topics:The Business Case for Women's Health Innovation – Why investors, manufacturers, and regulators are prioritizing this space and what it means for MedTech companies.Clinical Trials and Data Gaps – The urgent need for inclusive research, historical data biases, and evolving regulatory expectations.Regulatory and Market Access Hurdles – Key challenges in securing approval and reimbursement—and how to overcome them.Scaling Women's Health Solutions – Lessons from industry leaders on funding, partnerships, and commercialization strategies.Who should listen:MedTech professionals driving innovation in women's healthRegulatory and quality leaders navigating complex approval pathwaysClinical trial specialists improving diversity and data accuracyInvestors and strategists seeking insights into funding and market growthR&D and product development teams designing women's health solutionsHealthcare policymakers and advocates shaping the future of women's health innovationPanelists and moderator:Marissa Fayer – CEO, Her Health Equity & DeepLook MedicalMegan Callanan – US & Global Regulatory Lead, Natural CyclesStephanie Kladakis – Executive Vice President, Chief Technology and Regulatory Officer, AgNovos BioscienceAlexia Haralambous – Senior Principal, RQM+Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)Chapters:00:00 Introduction to Women's Health in MedTech10:09 The Surge in Women's Health Innovation20:08 Regulatory Challenges in Women's Health29:52 The Business Case for Women's Health Innovation33:54 Bridging the Gender Gap in Clinical Trials37:02 Enhancing Diversity in Clinical Trial Recruitment40:08 Understanding Regulatory Misconceptions in Women's Health44:09 Strategic Partnerships for Market Access56:03 Future Directions for Women's Health Innovation--

⁠This panel was recorded 30 January 2025.⁠⁠Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.Join part two of our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable insights for medical device manufacturers.Our panel of industry experts will provide clear, implementable guidance on:Practical strategies for meeting EU MDR and US FDA cybersecurity requirements - with real-world examples and documentation approachesEssential security considerations for medical devices, IVDs and SaMD developmentHow to integrate cybersecurity requirements into your quality management system from the startStandards for risk management, pre- and post-market considerations that satisfy both regulatory requirements and long-term security objectivesStrategic planning for maintaining security throughout your product lifecycleCommon pitfalls to avoid in cybersecurity implementation and regulatory submissionsThe role of SBOMs (Software Bills of Materials) in achieving transparency and regulatory complianceWho Should Attend:This session is essential for medical device manufacturers, software developers, quality professionals, and regulatory teams working with connected devices or SaMD. Whether you're bringing your first connected device to market or optimizing your current cybersecurity approach, you'll gain practical insights for ensuring both compliance and security.Panelists:Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation, RQM+Mirko Raner – Cybersecurity Consultant, RQM+Hrishikesh Gadagkar – Senior Principal, RQM+Moderator:Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+Register now to gain practical insights that will help you navigate the evolving cybersecurity landscape with confidence, backed by RQM+'s extensive experience in medical device regulatory compliance and software validation.Part one is available on demand here.Chapters00:00 Introduction to Medical Device Cybersecurity03:21 Navigating FDA Regulations and Cybersecurity11:38 Effective Documentation Frameworks for Cybersecurity15:47 Understanding Medical Device Data Systems (MDDS)24:12 Cybersecurity Challenges for In Vitro Diagnostic (IVD) Devices27:02 Addressing Cybersecurity in Interconnected Devices32:41 Risk Assessment and Cybersecurity Documentation37:12 Understanding FDA Regulations for Medical Devices40:54 Cybersecurity Considerations in Medical Devices42:00 Assessing Cybersecurity Threats and Vulnerabilities49:02 The Role of Risk Analysis in Cybersecurity Documentation56:46 Integrating Cybersecurity and Safety Risk Assessments01:09:53 Future-Proofing Against Cyber Threats--

Nicholas Capman of The FDA Group welcomes Ashley Preston, SVP of Global Regulatory Affairs & Quality Assurance at BlossomHill Therapeutics, to discuss the critical elements of successful regulatory agency meetings. With over 20 years of experience in regulatory affairs and quality assurance, Ashley shares expertise on preparing for and executing effective interactions with FDA and EMA.While the FDA and EMA are both considered first-tier regulatory agencies, they handle meetings differently. FDA offers various meeting types with structured timelines, while EMA takes a more committee-based approach through the CHMP.FDA meetings include several key types, from pre-IND consultations to end-of-phase meetings. The end of phase two meeting, where sponsors agree on pivotal trial designs, and the pre-NDA meeting are considered required interactions. Recent initiatives like Project Optimus have made end-of-phase 1 meetings increasingly critical, particularly in oncology. While FDA meetings are covered by PDUFA fees, EMA scientific advice can cost 70,000-80,000 euros unless the product has orphan designation.Meeting preparation requires careful strategy and timing. Preston emphasizes the importance of having sufficient data to support proposed development plans, noting that companies sometimes seek meetings too early, leading to delays or unfavorable feedback. Teams must craft focused questions and present just enough data to make persuasive arguments without overwhelming reviewers.Effective negotiation during meetings requires understanding agency perspectives and finding a middle ground when disagreements arise. Preston advocates for a partnership approach, recognizing that regulators share the ultimate goal of bringing safe, effective medicines to patients. Teams should prepare for various scenarios and be ready to suggest alternative approaches that address agency concerns while maintaining development efficiency.Documentation has evolved in the post-COVID era, with the FDA often drafting minutes during meetings. This real-time approach allows sponsors to ensure critical decisions and agreements are accurately captured. Follow-up mechanisms, from informal clarifications to formal Type D meetings, provide opportunities to address any remaining questions or challenges that emerge during implementation.Preston recommends that companies prepare for their first agency meetings by viewing these interactions as opportunities to build relationships and understand agency expectations. While virtual meetings have become common and efficient, maintaining professional, science-based discussions remains crucial regardless of format. Companies working with both the FDA and the EMA should consider how to harmonize feedback, potentially using sequential meetings to incorporate initial FDA input into EMA discussions.———The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our regulatory affairs expertise spans the entire drug development cycle, from pre-IND strategy through approval. For project or resource needs, visit ⁠thefdagroup.com⁠.

⁠This panel was recorded 12 December 2024. ⁠Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠at RQMplus.com. Thank you for tuning in.

This presentation and panel was recorded 4 October 2024. We encourage you to download the slides presented during this session by ⁠⁠⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠at RQMplus.com. Thank you for tuning in.

Listen in to not one but several fantastic MedTech leaders share their career stories and lessons in this special Future Leader Sessions episode of Career Diaries. This session - Leading the Business Around You - covers:Partnering with the business; what stakeholders really wantGetting C-suite buy-inNetworking and building relationshipsInfluencing others Our fantastic panel features:Monika McDole-Russell Sr. Director, Global Regulatory Affairs at Medtronic Endoscopy Elizabeth GfoellerCorporate Director, Regulatory Affairs at MED-ELStefan FischerSVP Regulatory Affairs at Paul Hartmann AGKarim DjamshidiVice President - Global Patient Health & Regulatory Compliance at KARL STORZ SE & Co. KGDon't forget you can register for our Future Leader Sessions for free - just follow us on Linkedin to know when they're released > https://www.linkedin.com/company/elemed/ Prefer to watch the recording? Watch it for free here > https://www.elemed.eu/news-insights/future-leader-sessions-leading-the-business-around-you/Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

In this podcast, Janelle Hart, Managing Editor at Citeline, teams up with industry experts Mai Yee Mishir, Senior Director of Global Regulatory Affairs, and Sally-Ann McDowell, Senior Director of Clinical Development Strategy at Advanced Clinical, to discuss the vital role of HRQoL in clinical trials. Listen now.

This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by ⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠ ⁠⁠at RQMplus.com. Thank you for tuning in.

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠reach out to RQM+⁠⁠⁠ if you need support with clinical trials.*

In 2013, Amazon founder and then CEO Jeff Bezos told 60 Minutes that his company would be delivering packages via DRONE within 5 years. It took a little bit longer… but not much. Since December 2022, customers in College Station, Texas have been able to get small packages delivered by unmanned Amazon aircrafts. And last week, Amazon announced that the FAA has authorized its drone program, called Prime Air, to fly even farther, beyond the view of human operators.  Amazon joins Google's subsidiary Wing, and companies like UPS and Zipline, which have already received similar approval from the FAA.   Guests: Matt McCardle, Director of Global Regulatory Affairs and Strategy for Amazon Prime Air Paresh Dave, Senior Writer for Wired Related Links: Amazon Drone Delivery Plans Move a Small Step Forward Amazon's Delivery Drones Won't Fly in Arizona's Summer Heat Amazon's Drone Delivery Dream Is Crashing See omnystudio.com/listener for privacy information.

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. "Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way." Scott Edwards, Managing Director at RQM+, shares his extensive industry experience and personal journey in our latest

While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here. In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. Nancy is as highly a respected professional as you'll 

This episode of of the Medical Alley Podcast is a replay of a webinar hosted on January 31st titled: “Transforming Regulatory Compliance with Artificial Intelligence,” sponsored by RegDesk. The discussion focused on how artificial intelligence is impacting regulatory compliance, with a look at the growing complexity in the regulatory space and why it is imperative that teams adapt.Panelists included: Priya Paul, Founder and CEO, RegDeskLiz Haines, Northeastern UniversityDon Ellis, Vice President, Global Regulatory Affairs, Reva MedicalFollow Medical Alley on social media on LinkedIn, Facebook, Twitter and Instagram.

RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip. In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process.

Raina Dauria has been a leader in the Johnson and Johnson family of companies since 2003. She is currently the Vice President Global Regulatory Affairs Policy at Johnson & Johnson MedTech, where she provides dedicated focus on critical regulatory policy issues to shape new and emerging regulations globally. In addition to her policy responsibilities, Raina leads the Regulatory Talent Management Strategy and the MedTech R&D Learning Sponsorship, which drives the benchmark Culture of Learning at Johnson & Johnson. Raina is dedicated to nurturing diverse talent, sponsoring leadership development and diversity recruitment programs. Tune in for- Misconceptions about soft skill- Overcoming adversity in your career- The hardest feedback Raina ever had to hear- Mistakes people make on their way to the topAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Listen in as Citeline sits down with a regulatory and compliance expert Mai Mishir, Senior Director, Global Regulatory Affairs from Advanced Clinical. Capture new insights into the present state of regulatory as advancements in technology, a shift to patient-centricity, and the globalization of clinical trials combine to change workflows and trial design. Plan your strategy now and develop new ways to master these complexities, with information from this free podcast.

Dr. P and Dr. Saraswathy Nochur discuss why it is imperative that people of diverse backgrounds participate in clinical trials. Dr. Nochur explains what happens before, during, and after a clinical trial and notes that  people can find a clinical trial for which they may be qualified by visiting www.clinicaltrials.gov.Saraswathy Nochur is Chief DE&I Officer at Alnylam Pharmaceuticals in Cambridge, MA where she works with various stakeholders to increase diversity, promote equity and foster inclusion at Alnylam, and also co-leads initiatives to increase diversity in clinical trials.  She previously was Head, Global Regulatory Affairs at Alnylam for 14 years, enabling the development and approval of four RNA interference therapeutics for rare diseases.  She has been in the Boston biotechnology industry since 1989.  Sara holds a Ph.D. in Biochemical Engineering from MIT.  Sara is on the Board of Marinus Pharmaceuticals, a company developing innovative therapeutics to treat rare seizure disorders and of Decibel Therapeutics, who are developing regenerative and gene therapy strategies to restore hearing and balance. She is a host and member of the Board of Hospitality Homes, a non-profit organization that provides free/low-cost housing for patients/families who seek medical care in Boston. She is also on the Board of Biomedical Science Careers Program (BSCP), a non-profit organization that aims to increase the representation of underrepresented minority and disadvantaged individuals in all facets of science and medicine.  Please note that the website "clinical trials.gov" was inadvertently referred to as "clintrials.gov" in this episode. Please visit www.clinicaltrials.gov to find out more information about clinical trials being conducted in the United States.

SOUNDS OF SCIENCE - EPISODE 15 On today's episode, we focus on the EU's Medical Device Regulation (MDR) which came into full effect on 26 May 2021 and followed by the In Vitro Diagnostic Device Regulation (IVDR) the following year. The idea of both regulations is to balance the regulatory review and approval processes of medical devices and IVDs across all EU Member States, essentially harmonizing the European market for medical devices. However, the Medical Device Regulation is causing some problems, and stakeholders and politicians at both the national and EU levels are warning that the MDR is leading to potential medical device shortages, and even medical devices disappearing from the EU market as a whole. In short, the main problem is that under the MDR, all medical devices produced in Europe must be re-certified. Re-certification needs to be done by a notified body, which is a national organisation designated by an EU country to assess the conformity of devices placed on the market. The main reason for the shortages is the capacity of these notified bodies to recertify. There are currently only 36 notified bodies with 23,000 certificates that need to transfer very much at the same time. Also, most manufacturers are not prepared for the new and sometimes costly rules of the MDR. In light of all this, and primarily to prevent the imminent risk of shortages, the European Commission decided to amend the medical device and in vitro diagnostic regulations. To help us breakdown the recent changes and what it means for EU medical device companies, we're joined by three experts in the medical devices space: Jörg Plessl, Head of Global Regulatory Affairs, Norgine Megan Doyle, Director, Global Regulatory and R&D Policy, Amgen Axel Korth, Sr. Legal and Regulatory Affairs Advisor, EUCOPE  --------------------------------------------------------------------------------- If you're a medical device company looking to add your voice to the ongoing debate and need help navigating the complex EU medical device market, please reach out to EUCOPE's Leander Vranken (vranken@eucope.org) to learn how to join our MDR/IVDR Focus Group.

This special episode of Career Diaries by Elemed is for International Women's Day 2023 and is about Leading Inclusively in a Global Environment.Featuring Meg Mucha of Philips, Andreas Stange of TÜV SÜD, Kristine Tucker of Bausch & Lomb, and Matthew Schabacker of BD.Listen to their insightful perspectives!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Julie Bell Lindsay is CEO of the Center for Audit Quality, a nonprofit public policy organization representing U.S. public company auditors.Previously, Julie served as Managing Director and the Deputy Head of Global Regulatory Affairs at Citigroup, where she worked to formulate and execute regulatory policy strategy. Lindsay also managed Citigroup's $20 billion TARP repayment and $58 billion exchange offers in 2009. Julie previously counseled on Sarbanes-Oxley and other public company disclosure requirements at the SEC and in private practice. She holds degrees from The Ohio State University and Vanderbilt School of Law.On this episode of Outside In, Julie talks with Jon about what the accounting and auditing profession gets right, what it gets wrong, making it relevant for the future and attractive to the next generation. They discuss fraud and the CAQs public mission.

On this episode of Trade Talk, Tommy Cue talks with Allison Skidd the Sr. Manager of Global Regulatory Affairs with Rheem about the upcoming 2023 HVAC regulations. Allison is considered an expert on the regulations and shares her insight on what HVAC contractors can expect. Connect with Tommy and Allison: Tommy Cue, JB Warranties Allison Skidd, Rheem

Food insecurity, climate change, and sustainability are not words typically associated with the nutritional value of food. Even so, as USDA sets the stage to write their next Dietary Guidelines, activists are pushing to expand the federal government's definition what “nutrition” could mean to policymakers and consumers. At Potato Expo 2022, top experts in food policy sat down to talk about how anti-potato activists are trying to influence nutrition policy – and what the industry is doing to head them off at the pass.Guests: Allie Graham, MS, RDN, Senior Director, Food Policy & Global Regulatory Affairs, Food Directions Robert Guenther, Chief Public Policy Officer, International Fresh Produce Association The Eye on Potatoes Podcast is made possible by our presenting sponsor, Syngenta. Delivering solutions to help producers face the potato industry's complex challenges, Syngenta provides growers with unmatched field expertise along with an array of effective products. Explore syngenta-us.com/spud-doctor to discover solutions for your potato growing obstacles.

We are pleased to introduce the mini podcast series, Through the Biotech Lens: Molecule to Market, for emerging biopharma and biotech.  In episode 1, Patrice Hugo, Chief Scientific Officer of Q2 Solutions and Angela Gong, Director of Global Regulatory Affairs will discuss useful tips for biomarker selection and successful Investigational New Drug submission.

Patricia (Trish) Hurter, Dr. Patricia Hurter is CEO of Lyndra Therapeutics. Prior to Lyndra, Dr. Hurter was Senior Vice President of Pharmaceutical and Preclinical Sciences at Vertex Pharmaceuticals, Inc. She also served as Interim Head of Global Regulatory Affairs from 2013-2014 and oversaw several label expansions for Kalydeco® and the submission of the new drug application for Orkambi®. She played a leadership role in the development and commercialization of 5 transformative therapies for Vertex: Incivek®, Kalydeco®, Orkambi® and Symdeko® and Trikafta®. Prior to joining Vertex, Dr. Hurter was Director, Formulation Design and Characterization for Merck where she was a key member of the early development team for Januvia®, a treatment for type II diabetes. A respected thought leader in the pharmaceutical industry, Dr. Hurter is a frequent contributor to many scientific publications. At Vertex, she founded and was the executive sponsor of “IWILL,” a Vertex employee network devoted to the advancement of women leaders. As a member of the Advisory Board for Women in the Enterprise of Science & Technology (WEST), she mentors Boston-area women who are early or in the midst of their careers in STEM. She also champions the Posse Foundation, an organization that recruits high school students from diverse backgrounds and supports them as they pursue college degrees and beyond. She is a mentor to alumnae from the program. Dr. Hurter earned her Ph.D. in chemical engineering from the Massachusetts Institute of Technology, as well as an M.S. in mechanical engineering from West Virginia University and a B.Sc. in chemical engineering, cum laude, from the University of KwaZulu-Natal in Durban, South Africa. Jessica Ballinger Mrs. Ballinger is President and Chief Operations Officer of Lyndra Therapeutics. In her 25+ year career, she has contributed to the development and commercialization of more than 15 leading-edge patient therapies. Prior to joining Lyndra, she was a Senior Director at Biogen responsible for redesigning and transforming the patient-centered technical development organization. While at Biogen, she contributed to developing products in critical therapeutic areas such as hemophilia, Alzheimer's Disease, spinal muscular atrophy and multiple sclerosis, delivering high-quality, highly-innovative, globally approved products with three products filed and approved in just three years. Prior to Biogen, she was the Senior Director Injectable Product and Device Strategy and Business Unit Interface driving technology development and lifecycle management innovation priorities for injectable products and devices in partnership with Pfizer Business Units and R&D. While in this role, Ballinger delivered ~50% capital investment savings and 25% cost-of-goods reduction through an innovative injectable device platform. She led the technical development and manufacturing scale-up of critical therapies in diabetes, endocrinology, neurology, ophthalmology, cardiovascular, women's health and men's sexual health. Ballinger is a respected leader in diversity and inclusion, co-creating the inaugural Biogen Alzheimer's Patient and Caregiver Employee Resource Network (ERN), co-leading the inaugural Biogen Women's Innovation Network, and co-leading the inaugural Pfizer European Women's ERN. She was appointed to the inaugural Chief of Staff position supporting the Pfizer European R&D and Site Leader during her time at Pfizer Sandwich. She received the honorable Pfizer R&D Achievement Award twice in her tenure at Pfizer, recognizing her strong leadership and business impact. Ballinger is an active volunteer in fundraising and leadership roles, working with the Oasis Domestic Abuse Service and the Melanoma Education Foundation. She holds a Bachelor's degree in Biochemistry from the University of Illinois – Champaign/Urbana.

Global demand for micro-chips has exploded. Today a worldwide shortage of semi-conductors is disrupting supply-chains of everything from cars to smartphones to the gaming consoles that normally see a peak in sales this time of year. This comes at a time when Europe's share across the semi-conductor value chain has shrunk, leaving the EU dependent on chips from Asia. In addition, the havoc wreaked by COVID-19 on supply chains suggests that being dependent is being vulnerable, especially in a global environment characterised by trade wars and geopolitical power games. It is against this backdrop that European Commission president von der Leyen in September announced a European Chips Act to promote European chips production. Proponents say this will give Europe its security of supply. Opponents say it will fail to guarantee supply, whilst making us poorer and less productive in the process. This event features a panel of expert speakers to discuss these issues, including: Kim Jørgensen, Head of Cabinet of European Commission Vice-President for a Europe Fit for the Digital Age, Margrethe Vestager; Thomas Bustrup, Deputy Director General of the Confederation of Danish Industry; and Greg Slater, Director of Global Regulatory Affairs at Intel. Think Tank EUROPA in Denmark and the Institute of International and European Affairs (IIEA) in Ireland look forward to welcoming you to this event. This event is part of a project entitled Europe's Digital Future, which is exploring the topic of digital sovereignty in Europe. The project is coordinated by the IIEA and is supported by Google. About the Speakers: Kim Jørgensen, Head of Cabinet of European Commission vice-president for a Europe Fit for the Digital Age, Margrethe Vestager Thomas Bustrup, Deputy Director General of the Confederation of Danish Industry Greg Slater, Director of Global Regulatory Affairs at Intel  This expert panel will be moderated by Catharina Sørensen, Deputy Director of Think Tank EUROPA.

This week, Stacey is joined by Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift to continuous manufacturing. This means all stages of drug production run through to the final product, without a stop during its production, thus shut down of equipment between “batches” is required, which eliminates downtime.  CM  saves time and reduces the likelihood of human error, but is it realistic at this point in time? Resources for this episode: FDA issued draft guidance, Quality Considerations for Continuous Manufacturing Rogers, Luke & Jensen, Klavs F. (2019). Continuous manufacturing – the Green Chemistry promise?. The Royal Society of Chemistry. Green Chem., Volume 21, 3481-3498. Moore, Christine M. V., Garcia, Thomas P., Hausner, Douglas B., Ben-Anat, Inna. (2019) Holistic Control Strategies for Continuous Manufacturing. Pharmaceutical Engineering, May/June 2019 Srai, Jagjit Singh., Settani, Ettore., Aulakh, Parminder Kaur., Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals: A Supply Network Perspective. Continuous Pharmaceutical Processing, June 2020, 477-512 Van Arnum, Patricia. Pharma Industry Weighs in on Continuous Manufacturing. June 19, 2019 Manning, Richard., Sciacca, Rich., Continuous Manufacturing in Pharmaceuticals: Economic and Policy Issues. Bates White Economic Consulting, October 2018 About Our Guest: Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research &  Development,  LLC,  a  pharmaceutical company of  Johnson  &  Johnson.  Renée has responsibility for Chemistry Manufacturing & Controls for API's and marketed products. Previously she has held positions in Regulatory Affairs at Johnson & Johnson Consumer Companies,  Wyeth  Consumer  Products,  a  small start-up pharma company, and an environmental chemistry laboratory.  Renée currently serves as an adjunct professor at Temple University School of Pharmacy where she teaches courses in good manufacturing practices and global drug registration requirements. She earned her Bachelor of Science in Biochemistry from Georgian Court College and a Master of Science in Regulatory Affairs from San Diego State University. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK has a few BTDs under its belt. Dr. Gupta is VP of Medicine Development at GSK and Dr. Ganeshan is formerly VP of Global Regulatory Affairs there, having recently joined Gilead as Head of Regulatory for Oncology. On this episode, we go deep on how to apply for--and win--breakthrough therapy designation with two women who couldn't be more qualified for the discussion.

Dr. Ekuta helps to educate us on the function of regulatory affairs by sharing an acronym he calls RCI. Regulatory Requirements, Compliance, and Interaction. He shares how regulatory affairs professionals can had value to companies at all stages of the process, pre-clinical to post-market. Dr. Ekuta is currently the VP of Global Regulatory Affairs with Alexion Pharmaceuticals and is an accomplished RA and pharmacovigilance executive. Learn some of his secrets to regulatory strategy.

 Ambily BanerjeeLeila is joined by Ambily Banerjee, Director, Therapeutic Groups, Global Regulatory Affairs at GSK.  IN THIS EPISODE YOU WILL LEARN ABOUT -    · Ambily background and how her career was a happy accident. ·Gender equality should encompass all women. ·A common enemy amongst us all is  “bias” and  the solution is “allyship”.· Inclusion dialogues and initiatives leading the way.   RESOURCES & INFORMATION MENTIONEDwww.linkedin.com/in/ambily-banerjee-85455116/?originalSubdomain=uk

This week, Stacey is joined by Paul Pluta and Karen Zimm to discuss the particulars of the drug naming process, definitions, and categories for drug names. Karen and Paul present case study scenarios where drug name communications have led to adverse events.  A drug may be known by different names during its development and commercial lifecycle. Medication safety problems associated with drug names have long been recognized as a significant problem by healthcare professionals. Whether it's look alike or sound alike errors, drug modifier misidentification, or proprietary vs. non-proprietary names, confusion may lead to medication errors – which of course can have fatal effects on patients and consumers. Resources for this Episode: Articles: Medication Safety: Industry Considerations Part 1 - Problem Overview https://www.ivtnetwork.com/article/medication-safety-industry-considerations-part-1-problem-overview  Regulatory 101: Medication Safety - Industry Considerations, Part 2, Drug Names https://www.ivtnetwork.com/article/regulatory-101-medication-safety-industry-considerations-part-2-drug-names Regulatory 101: Drug Name Modifiers – Definition, Categories, Generics, And CAPA https://www.ivtnetwork.com/article/regulatory-101-drug-name-modifiers-%E2%80%93-definition-categories-generics-and-capa Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology And Format https://www.ivtnetwork.com/article/regulatory-101-biologic-non-proprietary-drug-names-%E2%80%93-terminology-and-format  Medication Safety And Drug Names - Valproic Acid Product Problems https://www.ivtnetwork.com/article/medication-safety-and-drug-names-valproic-acid-product-problems References: FDA.  Guidance for Industry.  Best Practices in Developing Proprietary Names for Drugs. https://www.fda.gov/media/88496/download  FDA.  Contents of a Complete Submission for the Evaluation of Proprietary Names.  https://www.fda.gov/media/72144/download  FDA.  Safety Considerations for Product Design to Minimize Medication Errors.  https://www.fda.gov/media/84903/download  FDA. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.  https://www.fda.gov/media/85879/download  Medicines & Healthcare products Regulatory Agency (UK MHRA).  MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/810914/MHRA_Guideline_for_the_Naming_of_Medicinal_Products_and_Braille_Requirements_for_Name_on_Label.pdf.%C2%A0 European Medicines Agency (EMA).  Guideline on the acceptability of names for human medicinal products processed through the centralized  procedure. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf. Health Canada.  Guidance Document for Industry.  Review of Drug Brand Names.  https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-industry-review-drug-brand-names.html Health Product Regulatory Authority (Ireland).  Guide to Invented Names of Human Medicines.  file:///D:/HPRA%20Drug%20names.pdf.  To Err is Human:  Building a Safer Health System.  Institute of Medicine, National Academic Press, Washington, DC, 2000.  https://www.ncbi.nlm.nih.gov/books/NBK225182  Preventing Medication Errors.  Institute of Medicine.  National Academic Press., Washington, DC, 2007. https://www.nap.edu/catalog/11623/preventing-medication-errors  Karen R. Zimm, Ph.D.  Karen is currently an Associate Director in Global Regulatory Affairs for Johnson & Johnson Pharmaceutical Research and Development with responsibility for Chemistry Manufacturing & Controls for API's and marketed products. Previously she has held positions in technical operations with Pharmaceutical Sourcing Group – Americas, a division of Ortho-McNeil Pharmaceutical and research & development for the R.W. Johnson Pharmaceutical Research Institute and Whitehall Robins Healthcare (Wyeth Consumer Products). She earned her Bachelor of Science in Pharmacy and PhD in Pharmaceutics under Dr Joseph Schwartz from the Philadelphia College of Pharmacy and Science, MBA in Pharmaceutical Management from Drexel University, and the MS in Quality Assurance/Regulatory Affairs from Temple University. In addition she is a licensed pharmacist and an adjunct professor for the School of Pharmacy/Quality Assurance-Regulatory Affairs at Temple University in Philadelphia, PA. Paul L. Pluta, Ph.D. Paul is a pharmaceutical scientist with technical development, manufacturing, and management experience. He has been involved in nearly all phases of pharmaceutical development and manufacturing including R&D formulation and process development, dissolution, stability, regulatory, quality assurance/control, compliance, specifications, scale-up, technology transfer, technical support, and validation/qualification. In his time at Abbott he had numerous new product and supporting regulatory submissions, as well as, extensive product technical support experience. Additionally, his validation experience includes manufacturing process validation, cleaning validation, and associated systems qualification including aseptic systems. He was also a practicing pharmacist for many years in community and hospital environments with direct involvement in preventing medication errors. He may be reached at paul.pluta@comcast.net. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.   

Key takeaways:How a different background can ENRICH your perception as a Regulatory Affairs professionalDISCOVER the thin divide between Management and Regulation in Medtech and why it mattersThe BEST piece of advice that Thomas received in his careerWhy you should be focused on the BIG PICTUREAbout Thomas Meininghaus, VP RA at Ottobock:Thomas has been the Vice President for Global Regulatory Affairs at Ottobock since February 2019. He's in charge of their Legal Manufacturer as well as 200 Patient Care Clinics.He is a highly regarded, visionary and culturally sensitive business executive. Combining his engineering background (PhD) with strong commercial and quality expertise, he has a demonstrable track record of developing and implementing business strategy for medical device organisations in both the corporate and SME environment. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

In this episode, you'll meet James Rawls, PharmD, Vice President and Head of Global Regulatory Affairs at Sunovion Pharmaceuticals. James shares his incredible story of growth within Regulatory Affairs and—importantly—how he sees the diversity and inclusion landscape evolving in the pharmaceutical industry. What can companies do now to promote and support equal opportunity and access for all? What can industry pharmacists do to propel change? And how does James compare his Blackjack strategy to his career decisions? Get answers to these questions and more by listening in!

We're coming to the end of the throwback mini-series that I've been releasing over the past few months with some of my favorite Medsider guests of all time.In this discussion with Sheila Heyer, President of Heyer Regulatory Solutions and former VP of Global Regulatory Affairs at Boston Scientific, we learn where medical device companies are missing the mark when it comes to the FDA approval process. Here are some of the things we chatted about:The three most important steps you can take right now to get your medical device approved faster.Quality submissions and solid relationships: the importance of honing these two concepts in order to enhance your regulatory approval process.The key characteristics that great medtech regulatory professionals all have in common.Check out the full interview here.

Luciana comparte que estamos en un mundo volátil donde no sabemos qué pasará, se requiere visión y entendimiento de la situación. Comparte cómo la pandemia ha impactado en los trámites y actividades regulatorias.  Del lado de los consumidores, comenta que actualmente están buscando más productos enfocados en salud y bienestar,  que sean sustentables; los consumidores se han vuelto expertos en seleccionar productos por cómo se hacen, lo que tienen, el impacto en la sociedad y el medio ambiente.Sobre las habilidades que busca en su equipo destaca la capacidad de aprender, el entendimiento del negocio, y el ser aliado estratégico del negocio. Es importante que las personas estén motivadas, que crean en la compañía y que sientan que hay un equipo que los acompaña. Transmitir la pasión es muy importante.Luciana agrega que, 70% de tu desarrollo depende de ti mismo, el 20%  lo aprendes de tus mentores y 10% de cursos de capacitación.

Welcome to 19 Conversations. In our first conversation, Jacki Davis asks Mariano Votta, Director of Active Citizenship Network, and Michel Stoffel, Vice-President, Head of Europe Region, Global Regulatory Affairs, GSK Vaccines if vaccines for COVID-19 will be safe. Listen to hear their discussion on the challenge and how we're preparing for the future.Presented by the European Federation of Pharmaceutical Industries and Association See acast.com/privacy for privacy and opt-out information.

Lisa Carlton, PhD, understands rare childhood diseases both professionally and personally. She was already a scientist specializing in rare diseases when her daughter was diagnosed with one: tuberous sclerosis. As VP of Global Regulatory Affairs for a biotech drug developer she is involved in development of treatments for other rare diseases too. This makes her an ideal person to co-chair an industry-patient-advocacy group called the Working Group on Regulatory Science, a part of the EveryLife Foundation for Rare Disorders that seeks to advance the development of treatment and diagnostic opportunities for rare disease patients through science-driven public policy.Tuberous sclerosis, a rare genetic disorder, affects one in every 6,000 newborns in the United States. It is a disorder that causes benign growth in almost any tissue; it’s of particular concern when it occurs in the brain, lungs or kidneys. Some people who have tuberous sclerosis may have learning problems or difficult-to-control seizures. Her daughter—one of a pair of twins—was diagnosed in utero. She’s doing well, although the speech and language disorders associated with the condition have made it hard to access the curriculum in school. Dr. Carlton talks about the challenges of developing new treatments for rare diseases and the approaches taken to try to overcome them. She also talks about her daughter’s disease, and how families can bring their best to their journey as they adapt to support their child. Based on her experience as a parent and advocate—as well as her experience in the industry—she has this advice for families: “Take a breath.” Drug development is slow, especially in rare diseases. “You are in for a marathon of supporting your child.” When possible, connect with other parents and advocacy groups. Or build your own tribe—work, friends, family, etc. “You have to be healthy and rested enough to do this. You have to be at your best.” She’s often asked how she manages to keep going. “I don’t know how I wouldn’t do it. You’ve been given this gift of a special child. Now it’s time to find your tribe and push ahead.”Her advice for a biotech company considering launch of a clinical trial for a rare disease? Nobody knows more about a patient’s journey, the patient’s experience, than the patient—or a parent or caregiver. “Just listen to what patients are saying. You are going to learn a lot.”Lisa Carlton, PhD, has previously worked in regulatory roles at the National Institutes of Health, Otsuka Pharmaceuticals and International Partnership for Microbicides. She is currently serving as Vice President of Global Regulatory Affairs at REGENXBIO, a gene therapy-focused biotech company with headquarters in Rockville, MD. Lisa received her PhD in Pharmaceutics and MS in Medicinal Chemistry from the University of North Carolina in Chapel Hill and a BS in Biochemistry from North Carolina State University.

As part of the Pandemic Solutions: Virtual Speaker Series, KGI’s Rajesh Parti interviewed Dr. Steven Galson, Senior Vice President of Global Regulatory Affairs and Safety at Amgen. Dr. Galson has more than 20 years of experience in government service, including two years as acting Surgeon General of the United States. Previously, he served as director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation.

Dr. Clayman is a co-founder of Flexion Therapeutics and has served as our President, Chief Executive Officer and as one of our directors since our inception in 2007. Dr. Clayman also serves as the Chairman of the board of directors of both Anokion SA and Ribometrix. Previously, Dr. Clayman had a lengthy career at Eli Lilly and Company, where he was most recently Vice President, Lilly Research Laboratories, and General Manager of Chorus, Lilly’s early-phase development accelerator. During his career at Lilly, Dr. Clayman also led its Global Regulatory Affairs division, the Cardiovascular Discovery Research and Clinical Investigation, Research and Development at Advanced Cardiovascular Systems, a medical device subsidiary of Lilly, the Internal Medicine Division, the Lilly Clinic, Lilly’s dedicated Phase 1 unit, and served as Chair of Lilly’s Bioethics Committee. Prior to his tenure at Lilly, Dr. Clayman was an Assistant Professor in the School of Medicine at the University of Pennsylvania, where his research centered on the immunopathogenesis of renal disease. Dr. Clayman is the recipient of the Physician Scientist Award from the National Institutes of Health. Dr. Clayman earned a B.A., cum laude, from Yale University and an M.D. from the University of California, San Diego School of Medicine. Following an internship and residency in Internal Medicine at the University of California, San Francisco Moffitt Hospitals, Dr. Clayman completed clinical and research fellowships in Nephrology at the University of Pennsylvania.

“Though there's different perspectives, and different reasons why we're all in healthcare, it is all about the patient; and so, getting patient access to important therapeutics that change their lives is why we're all here,” suggests Sandra Milligan, Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck. “It's amazing to see regulatory agencies stepping up, recognizing that the health of their population is so important. Look at the regulatory revolution in China. Incredible. Having a healthy population is key to economic success.”

Dr. Mark Mannebach, former VP of Global Regulatory Affairs & Quality Assurance at Charleston Laboratories joins us to share his insights on what it took to get to "the top". Mark joins us today with over 30 years of pharma industry experience, the majority in Regulatory Affairs. Over the years, Mark has held a variety of influential leadership roles with organizations such as Pfizer, Medtronic, Mallincrodkt, Baxter, and Santen. Mark shares with us his insights of how he developed a passion for the industry at large, took to an interest in Regulatory, what he looks for when building his Elite teams, and why it's a great career path for those interested in learning more about RA/QA.

In this episode, KGI President Sheldon Schuster chats with Mary Ellen Cosenza, who is a regulatory consultant with more than 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. Most recently, she served as the Executive Director, U.S. Regulatory Affairs, at Amgen. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership roles in Regulatory Affairs, she also served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist for the Medical Research Division of American Cyanimid Company (now Pfizer).

At Northeastern, Stephen Amato oversees the faculty and educational services program within each of these key functional areas.  Prior to joining Northeastern, Steve built a decorated  25+ year career having held a variety of leadership roles within the healthcare and life sciences industries such as Director of Global Regulatory Affairs, Reimbursement & Distribution, Director of Market Access and Marketing.  During this episode we discuss the controversial topic of the value and benefits of pursuing a Masters degree in Regulatory Affairs.  Some of the main points covered: -Why should one consider pursuing an advanced degree in Reg Affairs -Benefits students are receiving post-graduation as a result of their advanced degree -Job outlook and market demand for Reg Affairs professionals -Emerging trends Steve is seeing in this space (forecast over next 5 years)

Urte Gayko-Head of Global Regulatory Affairs & PMO-Pharmacyclics/Abbvie Urte holds her PhD in Cellular and Molecular Biology from Harvard University and has spent close to 20 years building her career in the area of Regulatory Affairs. *This episode will be launched Thursday Some takeaways from Urte: -What is was like growing up as a child in Germany and how it ultimately helped shape her leadership mindset -How to make yourself, as a leader, visible amongst a sea of competition -How to establish the culture you want by living it

In this episode we talk with Jateh Major, a first year fellow in Global Regulatory Affairs at Merck. Listen in to hear more about the responsibilities of Reg Affairs fellow, how to stand out at your onsite interviews and Jateh's embarrassing moment/cautionary tale for candidates. Music Credit: Scott Holmes - Rad Adventure

In this first episode of our series on podcasting, Jason Hartman hears founder of Palladium Education, Inc, Alex Haddox's story of how he began podcasting to enhance his business. One of Alex's favorite things to do was radio shows and was in public relations for many years. He began marketing his seminars through podcasts and building his brand. Alex currently has over 200 podcasts. He explains how he tracked downloads, noting that it takes a while to build up a listening audience. He learned how to engage the audience and to fulfill their desire for more episodes. He came up with the idea of doing a Quick Tip every other episode. As he posted these podcasts, his listening audience increased six-fold. He encourages consistency and diligence, explaining that having a passion for it, for the content, is very important for success. Alex calls podcasting a “long game.” He has his own equipment, does his own editing and uploading, and has low overhead costs. By joining a podcasting network, Alex's audience doubled. He explains the benefits of the podcast network, i.e. the support and rapport that is built, leading to a close knit group of podcasters. All in all, Alex has experienced great success with his podcasts, having never spent money on advertising for his show, and managing the process himself. Alex Haddox's diverse background led him to founding Palladium Education, Inc., Workplace Violence Prevention and Crisis Intervention Training. Mr. Haddox spent nearly a decade working for Amgen, Inc., one of the world's largest multinational biotech firms, as a Senior Business Analyst and Senior eLearning Analyst. Among his many projects, he designed instructor-led and e-learning training modules for the Global Regulatory Affairs and Safety Education and Development department. Mr. Haddox was also the Product Manager and co-founder of the Symantec AntiVirus Research Center (SARC). He was considered one of the world's leading computer virus experts, traveled worldwide on speaking engagements, and appeared on national television programs including Good Morning America, CNBC, the Discovery Channel and Fox News Network. He has been quoted in innumerable print publications from The New York Times to USA Today and was on the Advisory Board to the industry's leading publication, “Virus Bulletin.” Mr. Haddox is a skilled martial artist and self-defense instructor. He has nearly two decades of combined traditional martial arts training in multiple styles including American Kenpo, Hapkido and Gracie Jiu-Jitsu. Mr. Haddox also holds firearms instructor credentials from the National Rifle Association.