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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The European Union has rejected Lilly's Alzheimer's drug Kisunla, citing potential risks of brain swelling and bleeding. This decision follows a similar rejection of a rival drug, Leqembi. Novo Nordisk is facing challenges in its weight loss business due to compounded versions of its drug Semaglutide making up a significant portion of the market. Milestone Pharmaceuticals experienced a setback when the FDA issued a complete response letter for its tachycardia drug Cardamyst. The company is now focusing on restructuring and streamlining operations.Merck's injectable Keytruda has shown promising results in a pivotal trial, and BioNTech's bispecific treatment has elicited positive responses in the majority of patients with small cell lung cancer. Novo Nordisk's stock dipped after disappointing weight loss results for Cagrisema, and Biogen and Eisai's drug Leqembi faced setbacks in the UK and Australia. In other news, United States Pharmacopeia is offering career opportunities in various fields including science, technology, regulatory affairs, and quality assurance. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology industries.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., has revealed intentions to reduce 10,000 positions and restructure departments. The appointment of vaccine critic David Geier to investigate vaccine safety within the CDC has also been announced. Soleno has recently obtained FDA approval for a medication designed to address hyperphagia in Prader-Willi syndrome patients. Meanwhile, Johnson & Johnson's combination therapy for lung cancer has displayed encouraging outcomes. A power struggle at Aurion has resulted in Alcon taking control, amidst allegations of impeding Aurion's IPO plans. Opportunities in the biopharma industry are available at the United States Pharmacopeia, alongside updates on biopharma layoffs and industry advancements. That's all for today's episode. Stay tuned for more essential news from the world of Pharma and Biotech. Thank you for listening.
Tieraona Low Dog, MD, ABOIM, joins Integrative Practitioner Content Specialist Avery St. Onge to discuss her journey as an integrative medicine doctor after being honored as a pioneer in the field at the Integrative Healthcare Symposium's 20th anniversary celebration. About the Expert Tieraona Low Dog, M.D.'s path in integrative medicine is unique, shaped by her deep connection to the natural world. Her academic journey is a testament to her diverse interests and commitment to whole health, spanning disciplines such as massage therapy, martial arts, midwifery, and herbal medicine before culminating in her medical degree from the University of New Mexico School of Medicine. Dr. Low Dog's influence in the field of integrative medicine is undeniable. She was a founding member of the American Board of Integrative Medicine and among the first physicians to be board-certified in this emerging field. Her leadership is demonstrated by her roles as Director of the first Inter-professional Fellowship in Integrative Health and Medicine, Fellowship Director for the University of Arizona's Center for Integrative Medicine, and Co-Founder of the New York Zen Center's Fellowship in Contemplative Medicine. She is the Founding Director of the Integrative and Functional Medicine Fellowship at the University of California-Irvine's Susan Samueli Integrative Health Institute. Dr. Low Dog's dedication to public service is exemplified by her appointments to significant positions, including her service on the White House Commission for Complementary and Alternative Medicine Policy by President Bill Clinton, her appointment under the Bush Administration to an advisory role at the NIH National Center for Complementary and Alternative Medicine, and her long-standing role (25 years) as Chair for various dietary supplements and botanicals expert panels at the United States Pharmacopeia.
The FDA Group's Nick Capman sits down with pharmaceutical scientist and consultant Gary Ritchie to discuss the intricacies of statistical sampling in biopharmaceuticals. They explore the limitations of the square root of n plus one sampling method, particularly for small lot sizes, and the advantages of more rigorous statistical approaches. Discussion points include: Limitations of Square Root of n + 1: Gary explains why this commonly used method is inadequate for small biopharmaceutical lot sizes, leading to potential risks in sample representativity and patient safety. Importance of Proper Sampling: Gary highlights the need for statistically valid sampling plans considering lot size, inspection levels, and acceptance quality levels (AQLs) to ensure representative sampling and compliance with regulatory requirements. Cost and Risk Management: The discussion emphasizes how improper sampling can increase business costs and risk to patients, while proper sampling can offer significant cost savings and better risk management. Adoption of ANSI Standards: Gary encourages the industry to adopt ANSI standards for sampling, demystifying the complexity of statistical methods and emphasizing their importance for compliance and efficiency. Practical Implementation: Gary shares insights from his experience, recommending resources and literature for better understanding and applying statistical sampling in the pharmaceutical industry, including Dan O'Leary's paper "Attributes Acceptance Sampling: Understanding How It Works" and Ron Snee's "Solving Statistical Mysteries: What Does the FDA Want?" Gary Ritchie is a veteran pharmaceutical scientist with nearly 30 years of experience in the life sciences industry. He specializes in statistical sampling, analytical chemistry, and pharmaceutical waters. Gary's expertise spans various areas, including process analytics, quality control, and regulatory affairs. Gary's held key positions at the United States Pharmacopeia, where he served for five years on expert committees for waters, statistics, and general chapters. His experience as a liaison allowed him to work closely with the FDA, industry leaders, and academia. — 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. For project or resource needs, visit thefdagroup.com.
SCP-7340 designates a group of storage drums containing United States Pharmacopeia grade isoflurane, a general anesthetic commonly used in surgery… Content Warnings: Descriptions of medical harm, and medical procedures performed without patient consent Transcript Patrons Norama, Cruz, Anna Garrett, Vintilescu Andrei, GaffyWaffy, MangoLemur, Dakota Fine, and AllHaulCthuhlu! Cast & Crew SCP Archives was created by Pacific S. Obadiah & Jon Grilz SCP-7340 was written by bigslothonmyface Script by Kevin Whitlock Narrator - Rhys Tirado Dr. Pitts - Ben Counter Wright - Karim Kronfli Art by Eduardo Valdés-Hevia Video produced by Dakota Miller Theme Song by Matt Roi Berger Original Music Composed by Dana Creasman Sound Designer - Daisy McNamara Showrunner - Daisy McNamara Creative Director - Pacific S. Obadiah Executive Producers - Tom Owen & Brad Miska Presented by Bloody FM www.Bloody-Disgusting.com www.SCParchives.com Patreon: https://www.patreon.com/scp_pod Store: https://store.dftba.com/collections/scp-archives Twitter: https://twitter.com/scp_pod Facebook: https://www.facebook.com/scppod Discord: https://discord.gg/tJEeNUzeZX Learn more about your ad choices. Visit megaphone.fm/adchoices
Matt Grissinger, RPh, FISMP, FASCP is the Director of Education at the Institute for Safe Medication Practices (also known as ISMP). During our conversation, we talk about ISMP's Targeted Medication Safety Best Practices for Community Pharmacy first. Then, we talk about how to report an error, CPE available from past ISMP webinars, adding education on operations to the pharmacy school curriculum, and more. This is a great episode for any pharmacist, pharmacy student, pharmacy technician, or pharmacy owner. Medication Safety is important. Thank you for listening to episode 280 of The Pharmacist's Voice ® Podcast! To read the FULL show notes, visit https://www.thepharmacistsvoice.com/podcast. Select episode 280. Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out! Apple Podcasts https://apple.co/42yqXOG Spotify https://spoti.fi/3qAk3uY Amazon/Audible https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt Bio (May 2024) Matthew Grissinger, RPh, FISMP, FASCP is the Director of Education at the Institute for Safe Medication Practices (ISMP). He first joined ISMP in 2000 as an ISMP Safe Medication Management Fellow. Prior to joining ISMP, he served as a home care and long-term care pharmacy surveyor for the Joint Commission. He was project leader for the Hospital and Healthsystem Association of Pennsylvania (HAP) Hospital Improvement Innovation Network's (HIIN) Adverse Drug Event (ADE) Project, a collaborative project engaging healthcare organizations to reduce and prevent patient harm from the use of anticoagulants, insulins, and opioids. He has published numerous articles in the pharmacy literature, including regular columns in P&T and is a journal reviewer for a number of publications including the Joint Commission Journal on Quality and Patient Safety, Pharmacoepidemiology, Journal of Managed Care and Specialty Pharmacy, BMJ Quality and Drug Safety, and Annals of Internal Medicine. He is a chapter contributor to a textbook published by McGraw-Hill entitled Pharmacy Management: Essentials for All Practice Settings, Essentials of Nurse Informatics, Remington: The Science and Practice of Pharmacy, and Medication Errors. He is recently completed the Just Culture certification course. Mr. Grissinger serves as the Chair for the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), and Co-Chair of the National Quality Form (NQF) Common Formats Expert Panel. He is also on the Faculty Advisory Board for the Pharmacy Learning Network (PLN) and the Publications Advisory Board for Davis's Drug Guide for Nurses. He also served on the WHO Focus Group on Measurement Tools for Medication Safety, United States Pharmacopeia's (USP) Safe Medication Use Expert Committee from 2005-2010, the FDA Proprietary Name Review Concept Paper workshop panel in 2008, FDA Naming, Labeling, and Packaging Practices to Minimize Medication Errors workshop panel in 2010 and the Joint Commission Home Care Compounding Pharmacy Technical Advisory Panel in 2013. He is also an adjunct assistant professor for Temple University School of Pharmacy. Mr. Grissinger received a BS in Pharmacy from the Philadelphia College of Pharmacy and Science and is a fellow of the Institute for Safe Medication Practices as well as the American Society of Consultant Pharmacists. Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out! Apple Podcasts https://apple.co/42yqXOG Spotify https://spoti.fi/3qAk3uY Amazon/Audible https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt Links from this episode Matt Grissinger on LinkedIn https://www.linkedin.com/in/matthew-grissinger-63231ab/ ISMPs new website
Jeffrey Gladd, MD With twenty-one years of experience in the medical field, Dr. Jeff Gladd, MD is the owner of GladdMD Integrative Medicine and since 2019 has been the Chief Medical Officer at Fullscript. Dr. Jeffrey Gladd graduated from Indiana University School of Medicine in 2001. He then went on to train in family medicine at Ball Memorial Hospital in Muncie, Indiana. After completing his residency, Gladd started a family practice that encompassed full spectrum care, including obstetrics, colonoscopy and endoscopy in Columbia City, Indiana In 2006. After the birth of his second child, Gladd transformed his professional and personal focus toward health through nutrition. By educating himself and applying the principles of eating whole foods, he lost 50 pounds, and reveled in improved energy and mental clarity. As a physician, increasing doses and adding medications was no longer acceptable. Gladd delved into his patients' lives — how they ate, how they managed stress, and discovered real health care. Gladd completed the University of Arizona Integrative Medicine fellowship program under the direction of Dr. Andrew Weil, MD at the end of 2009. While in the fellowship, Gladd served as the medical director of the Parkview Center for Integrative Medicine in Fort Wayne, Indiana, and in 2010 opened GladdMD Integrative Medicine where he blends health-promoting care with high access technology. With the success of GladdMD, Dr. Gladd has become a sought-after speaker on physician entrepreneurship, social media, and technology in healthcare. Tieraona Low Dog, MD From a young age, Dr. Tieraona Low Dog has been deeply drawn to the natural world and the field of natural medicine. Her academic journey encompasses a diverse range of disciplines including massage therapy, martial arts, midwifery, and herbal medicine, before going to earn her medical degree from the University of New Mexico School of Medicine. As a pioneer in the field, Dr. Low Dog not only served as a founding member of the American Board of Physician Specialties' American Board of Integrative Medicine; but she was also among the first cohort of physicians to be board certified in this newly emerging field. Her leadership extends to her tenure as Director of the first Inter-professional Fellowship in Integrative Health and Medicine, Fellowship Director for the University of Arizona's Center for Integrative Medicine that was founded by Andrew Weil, MD, and Co-Founder and guiding teacher for the New York Zen Center's Fellowship in Contemplative Medicine. She currently oversees the Fellowship of Integrative and Functional Medicine at the University of California-Irvine's Susan Samueli Integrative Health Institute. Dr. Low Dog's dedication to public service is exemplified by her appointments to significant positions, including her service on the White House Commission for Complementary and Alternative Medicine Policy by President Bill Clinton and her advisory role at the NIH National Center for Complementary and Alternative Medicine, being appointed by HHS Secretary Thompson under President George W. Bush. Her leadership has been instrumental in her long-standing role (25 years) as Chair for various dietary supplements and botanicals expert panels at the United States Pharmacopeia. Recognized as a foremost authority in integrative medicine, women's health, dietary supplements, and herbal medicine, her scholarly work encompasses over 54 peer-reviewed scientific articles, 25 chapters in medical textbooks, and numerous authoritative books on health and medicine. Dr. Low Dog's global influence is highlighted by her participation in over 600 medical and scientific conferences worldwide.
People most often use aloe vera as a topical medication, rubbing it onto the skin rather than consuming it. In fact, it has a long history of use in treating sores, and particularly burns, including sunburn. The United States Pharmacopeia describe aloe vera preparations as a skin protectant as early as 1810-1820 Studies suggest that it is an effective topical treatment for first- and second-degree burns. For example, a review trusted source of experimental studies found that aloe vera could reduce the healing time of burns by around 9 days compared with conventional medication. It also helped prevent redness, itching, and infections. The evidence for aloe vera helping heal other types of wounds is inconclusive, but the research is promising.
This past March 20th the United Nation's Intergovernmental Panel on Climate Change (IPCC) published its fourth and last sixth assessment cycle (AR6) report. This last report integrates the main findings of the IPCC's three, sixth assessment working group reports published over the past 18 months. The report has been informally termed the “last warning” since the IPCC 7th assessment work will likely not be published until after 2030 - at which time we'll know whether we have succeeded or not in reducing CO2e emissions by approximately 45% in order to limit avg global warming to the preferred Paris climate accord goal of 1.5C. Among other conclusions the IPCC authors warned, “There is a rapidly closing window of opportunity to secure a livable and sustainable future for all.” “The choices and actions implemented in this decade will have impacts now and for thousands of years.” The UN Secretary General, Antonio Guterres, termed this last report “a clarion call to massively fast-track climate efforts by every country, every sector and on every timeframe.” An excellent summary of the AR6 fourth report was published in late March by Carbon Brief, at: https://www.carbonbrief.org/carbon-briefs-definitive-guide-to-the-entire-ipcc-sixth-assessment-cycle/.This 35-minute interview Ms. Willis discusses Malaria No More's work, related/relevant IPCC findings and those in context of her attendance last month at a climate/health summit meeting in Abu Dhabi held in preparation for subsequent related discussions during this coming December's IPCC COP 28 meeting also taking place in the UAE. Ms. Kelly Willis is currently the Managing Director of Strategic Initiatives at Malaria No More. Ms. Willis has more than 20 years of experience working in infectious disease and global health, helping to build permanent capacity in health systems throughout sub-Saharan Africa and Southeast Asia, in roles including Senior Vice President at United States Pharmacopeia, Executive Director of Accordia Global Health Foundation and through her consulting firm Willis Solutions LLC. Ms. Willis's field experience includes several years living in East Africa where she helped launch and support the Infectious Diseases Institute at Makerere University and led a multi-year research program to better understand the impact of medical training programs on standards of care and health outcomes. Prior to that, Ms. Willis spent five years in multiple finance and economics management roles at Pfizer where she also served as a Global Health Fellow in Uganda. She holds a Distinguished Alumni award from Michigan State University where she earned a BA in French and an MBA in Supply Chain Management.The IPCC report is at: https://report.ipcc.ch/ar6syr/pdf/IPCC_AR6_SYR_SPM.pdf. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thehealthcarepolicypodcast.com
A mother, wife, herbalist, educator, author, researcher, and medical doctor, Tieraona has trained hundreds of medical professionals as the Fellowship Director at the University of Arizona Center for Integrative Medicine, chaired dietary supplement expert panels for the United States Pharmacopeia, and has been appointed to numerous scientific advisory boards. In addition, she has authored best-selling books (including 4 published by National Geographic) and written over 50 peer-reviewed articles and 25 book chapters. Tieraona was appointed by the President of the United States to serve on a White House policy commission, has received many awards from academia, public health, and industry, and has lectured at over 600 conferences. She is an incredible teacher with an equally incredible life story. In this episode, we discuss the world of maternal health as it relates to preparing for a healthy life and pregnancy setting the stage for a healthy child's life. I hope that you enjoy my conversation with Dr. Low Dog, Dr. M
Ron Piervincenzi, Ph.D., CEO of United States Pharmacopeia, returns to BioTalk to discuss USP's growth since his last visit, the nature of their organization, and plans on hosting the 2022 BioHealth Capital Region Forum in person at their beautiful building in Rockville, Maryland.
About Salah Kivlighn and HepaTx Corporation: My colleagues describe me as an inspiring results-driven leader with a rare blend of science and business acumen across several therapeutic classes, including oncology, autoimmunity and cardiovascular. I believe in leading with compassion and empathy; with this in mind I have built and led culturally diverse high performing teams located in countries around the world. As a commercial leader I have helped to build franchises with annual revenues in excess of 3 Billion dollars. My business experience spans the start-up sector to Fortune 100 organizations across the globe, including Merck & Co., MedImmune, Inc. (a subsidiary of AstraZeneca founded as Molecular Vaccines Inc. in 1988), AstraZeneca, Kite Pharma (a subsidiary of Gilead Sciences), NABI Biopharmaceuticals, and the United States Pharmacopeia, a nonprofit organization. As a scientist, commercial leader and global speaker, I have verified successes in oncology (mAb, cell-based, and immuno-oncology), vaccines, and cardiovascular disease treatments. My awards include the AstraZeneca CEO Award and the globally esteemed Prix Galien Award for Best Biotechnology Product (RotaTeq®). With unique and extensive experience in commercial and R&D pharma and biotech with full spectrum product life cycle responsibility, I've led pre-clinical / clinical R&D, global marketing and sales teams with international operations oversight. Most recently I oversaw all commercial aspects of seven business verticals: Small molecule generic medicine, Biologics, Dietary Supplements & Verification, Food, Excipients, Health Care Quality & Safety, and Global Education. Our vision is to provide regenerative medicine treatments that free patients from chronic liver disease and help usher in an era where diseased and damaged tissues can be repaired.
“The medical industry is like a sewer” Had a great conversation with @deplorablejanet on the history of the medical system. We spoke about the Medical System and their propensity for pharmaceuticals. The importance of your body being in an alkaline state, rather than acidic, which many people are today. We touch on the Rockefeller/Carnegie Medical System destruction of natural medicine via the Flexner Report. Why do all doctors not even possess United States Pharmacopeia book? Janet discusses the importance of getting your gut in line, gut biome is critical to health. She exposes the dangers of chemotherapy/radiation as cancer treatment. We transitioned into the 1800's and the Orphan Trains, Human Zoo's, Infantorium's and Free Energy to wrap up this fun discussion. Where you can find Janet's great work: Show her podcast some love and subscribe to the Deplorable Nation Podcast IG: @DeplorableJanet Twitter: @KnowJanet http://altmediaunited.com Lost History of Earth 5 hr doc: https://www.youtube.com/watch?v=8Ul0e6lw130&list=PLutYv7b1MpGEV8kANmDWce6hbrSMyuf2f&index=2&t=520s What Happened on Earth 8 hr doc: https://www.youtube.com/watch?v=hkBb-Np-7IU&list=PLutYv7b1MpGEV8kANmDWce6hbrSMyuf2f&index=7&t=12s
Dr. Amanda Guiraldelli-Mahr, Scientific Affairs Manager at the United States Pharmacopeia, discusses the various components of the AQbD workflow including: the analytical target profile, method design, method validation, and performance verification.
In this episode, we look at why vitamins are an important part of life. But be careful, they aren't always what they seem. Hosted By: Gregg Clunis | https://www.instagram.com/greggclunis/ Instagram: http://instagram.com/tinyleaps Twitter: http://twitter.com/tinyleaps Website: http://tlbc.co/tiny-leaps-big-changes Resources: National Institute on Aging. (2021). Vitamins and Minerals for Older Adults. US Department of Health and Human Services. Retrieved from https://www.nia.nih.gov/health/vitamins-and-minerals-older-adults. Katie Forster. (2017). Multivitamins Just Create ‘Very Expensive Urine,’ Medical Chief Warns. Independent. Retrieved from https://www.independent.co.uk/life-style/health-and-families/health-news/multivitamins-expensive-urine-waste-money-vitamins-australian-medical-association-chief-michael-gannon-supplements-a7578961.html. Centers for Disease Control. (2018). CDC’s Second Nutrition Report: A comprehensive biochemical assessment of the nutrition status of the US population. Retrieved from https://www.cdc.gov/nutritionreport/pdf/4page_%202nd%20nutrition%20report_508_032912.pdf. UnityPoint. (2020). How to Spot a Vitamin D Deficiency. UnityPoint Health LiveWell. Retrieved from https://www.unitypoint.org/livewell/article.aspx?id=ca7f4766-8ba8-43a2-bbe7-0ef9efab5c6d. Harvard Health Publishing. (2020). Vitamin B12 Deficiency Can Be Sneaky, Harmful. Harvard Health Publishing Harvard Medical School. Retrieved from https://www.health.harvard.edu/blog/vitamin-b12-deficiency-can-be-sneaky-harmful-201301105780. Food and Drug Administration. (2017). What You Need to Know about Dietary Supplements. FDA. Retrieved from https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements. National Health Service. (2020). Vegetarian and vegan diets. NHS. Retrieved from https://www.nhs.uk/live-well/eat-well/vegetarian-and-vegan-diets-q-and-a/#:~:text=Vitamin%20B12%20is%20only%20found,is%20fortified%20with%20vitamin%20B12. United States Pharmacopeia. (2020). What is the US Pharmacopeia? Retrieved from https://qualitymatters.usp.org/what-us-pharmacopeia. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app
This week we welcome Dr. Loyd Allen Jr. to the podcast. He is the editor-in-chief of the International Journal of Pharmaceutical Compounding (click here) and has been an outspoken advocate for improving quality in compounding as well as advising on multiple committees for the United States Pharmacopeia and the FDA. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site! --- Support this podcast: https://anchor.fm/pharmacy-inspection/support
This week we welcome Dr. Loyd Allen Jr. to the podcast. He is the editor-in-chief of the International Journal of Pharmaceutical Compounding (click here) and has been an outspoken advocate for improving quality in compounding as well as advising on multiple committees for the United States Pharmacopeia and the FDA. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
This week we welcome Dr. Loyd Allen Jr. to the podcast. He is the editor-in-chief of the International Journal of Pharmaceutical Compounding (click here) and has been an outspoken advocate for improving quality in compounding as well as advising on multiple committees for the United States Pharmacopeia and the FDA. WE'RE NOW ON iHEART RADIO PODCASTS (click here)! Sign up for updates from PharmacyInspection.com: [mc4wp_form id="14886"] If you like the podcast follow us on twitter @PharmacyInspect and share the podcast with those who might find it helpful. We're just getting warmed up; there's SO many more topics to cover! Stay tuned for what's to come! Thanks for listening. Do you have a question or comment for the show? Leave us a VOICEMAIL, right on our site!
ACHC/PCAB join with VGM, Attentus to discuss newest standards for compounding pharmacies Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), along with Attentus Medical Sales, Inc., a pharmacy and medical products manufacturer, and VGM and Associates, a member services organization serving the home medical equipment industry, today announced plans to host a series of free webinars to discuss the implications of recently-released hazardous drug safety standards by the United States Pharmacopeia convention, USP 800. "The pharmacy compounding industry is undergoing some significant regulatory changes," said José Domingos, ACHC CEO, referring specifically to the newly-released USP 800 as well as revisions to the existing standard for sterile compounding, USP 797. "I applaud Attentus and VGM for coming forward to recognize the need and support the information needs of compounding pharmacies." "Our home infusion and compounding pharmacies are under continuous regulatory and pricing pressures today so they are asking for direct answers and solutions for these changes to USP 800," said Tom Tucker V.P. Sales and Marketing, Attentus Medical Sales. "We see these webinars as a way to help our pharmacies break down these changes to manageable tasks." "VGM seeks out solutions to address challenges that its membership faces," said Frank Geiger, VGM Director Home Infusion. "USP 800 is going to be a complex change in the way business is conducted. VGM will take a leadership role in making sure our members have the information and support they need to be successful." The schedule for the webinars is as follows: May 3rd – 4:00 PM EST (Sterile) May 5th – 4:00 PM EST (Non-Sterile) May 9th – 1:00 PM EST (Non-Sterile) May 10th – 4:00 PM EST (Sterile) Interested parties can find more information and register for these webinars at: https://attendee.gotowebinar.com/register/7738522639425900546. As a leading accreditation organization, ACHC is committed to providing educational resources that facilitate continuous compliance. Through its educational division, Accreditation University, ACHC offers a range of resources designed to help pharmacies achieve and maintain compliance including workbooks, workshops, and compliance checklists as well as customized consulting options. ACHC is a non-profit accreditation organization that has stood as a symbol of quality and excellence since 1986. The organization has CMS Deeming Authority for Home Health, Hospice, and DMEPOS and a Quality Management System that is certified to ISO 9001:2008. ACHC is the provider's choice for accreditation because of its personal Accreditation Advisors, relevant and realistic standards, competitive pricing, and a friendly, consultative approach to accreditation. Accreditation by ACHC reflects an organization's dedication and commitment to meeting standards that facilitate a higher level of performance and patient care. As a service of ACHC, PCAB is the currently the only comprehensive accreditation solution for compounding pharmacies wishing to demonstrate compliance with USP standards. For more information on ACHC's accreditation programs, or to download ACHC accreditation standards, please visit http://www.achc.org or contact them at customerservice@achc.org or 855-937-2242. VGM Home Infusion is powered by the VGM Group, Inc., a national leader in providing business solutions for diverse industries including health care, insurance and golf. VGM provides a complete line of business solutions and purchasing contracts to more than 25,000 companies throughout the United States and Canada. From group purchasing contracts to continuing education; from audit, appeals and medical review consultation to market data, patient referrals and marketing services, VGM Home Infusion can help members grow revenue, manage expenses and remain compliant. Attentus Medical Sales, Inc, based in Houston TX, is a leading nationwide manufacturer and distributor of medical products specializing in cold chain packaging, USP 797 & USP 800 compliance products, infusion pumps and supplies, back packs and fanny packs for portable infusion pumps, and various other medical supplies. Attentus Medical services the compounding pharmacy, home infusion, specialty pharmacy, and HME markets. Founded in 2003, Attentus has experienced tremendous growth every year with a continuous focus on developing solutions for our customer's ever changing needs in this dynamic marketplace. We strive to provide the highest levels of personal attention and consideration to the client. Each client will have a dedicated sales rep and customer service rep as well as have their phone call answered by a live person every time. We are dedicated to providing a high level service and the consultative support for all your business needs. http://www.attentusmedical.com See omnystudio.com/listener for privacy information.
ACHC/PCAB join with VGM, Attentus to discuss newest standards for compounding pharmacies Pharmacy Compounding Accreditation Board (PCAB), a service of Accreditation Commission for Health Care (ACHC), along with Attentus Medical Sales, Inc., a pharmacy and medical products manufacturer, and VGM and Associates, a member services organization serving the home medical equipment industry, today announced plans to host a series of free webinars to discuss the implications of recently-released hazardous drug safety standards by the United States Pharmacopeia convention, USP 800. "The pharmacy compounding industry is undergoing some significant regulatory changes," said José Domingos, ACHC CEO, referring specifically to the newly-released USP 800 as well as revisions to the existing standard for sterile compounding, USP 797. "I appl
Nandini Kashyap interviews Dr. Daniel L. Norwood of Boehringer Ingelheim Pharmaceuticals on October 15, 2014. Dr. Norwood will be speaking during the 3rd Annual Extractables and Leachables conference which takes place on January 22-23 at the upcoming PepTalk event which runs from January 19th to 23rd, 2015 in San Diego, CA. Topics Include: Extractable, Leachable, PQRI – PODP, United States Pharmacopeia, FDA, Parenteral and Ophthalmic Drug Products, Single use technologies, Risk assessment, Analytical Study design for E&L, Regulatory consideration, Toxicological considerations, Cell Culture, Plastic Packaging Systems, Pharmaceutical Packaging/Delivery Systems, multi-product facilities , Leachables in Large Volume Parenteral Products
Dana Laake and her special guest Dr. Duffy MacKay will be discussing the recent media coverage of a study that suggests a higher risk of prostate cancer among men who eat omega-3 fatty acids. Dr. MacKay leads Scientific and Regulatory Affairs for the Council for Responsible Nutrition (CRN), the leading trade association representing dietary supplement manufacturers and ingredient suppliers. Dr. MacKay also serves on several advisory and editorial boards including the American Botanical Council, and the United States Pharmacopeia. Dr. MacKay maintains a part-time practice where he assists patients with integrating naturopathic medicine into their lives to support health, wellness, and chronic disease management.