RAPS recently published Essentials of Healthcare Product Labeling, a first of its kind book focusing specifically on the details and requirements for pharmaceuticals, biologics, medical devices and OTC products. The driving force behind that book was Cathleen O’Connell, RPh, MS, PhD. O’Connell, had a long career in the pharmaceutical industry, including more than a decade in labeling roles. Today, she is assistant professor of biomedical writing at the University of the Sciences in Philadelphia. RAPS senior editor Pam Jones sat down with O’Connell to discuss the labeling specialty and the book.

RAPS Podcasts

RAPS Podcast #6 - Product Labeling

All healthcare product manufacturers need Regulatory Intelligence to be successful in the marketplace. Meredith Brown-Tuttle, author of the soon-to-be released third edition of RAPS’ Regulatory Intelligence 101, discussed what RI is, how it works, what it takes to be a successful RI specialist and what it means to companies large and small.

RAPS Podcast #5 - Regulatory Intelligence

The new EU Medical Device Regulation will come into force in less than six months and manufacturers and regulators are scrambling to prepare. Sue Spencer of Qserve in the UK and Erik Vollebregt, partner at Axon Lawyers in Amsterdam, recently sat down with RAPS senior editor Pam Jones to discuss the current status of those preparations and what can be expected.

RAPS Podcast #4 - MDR/IVDR

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.

RAPS Podcast #3 - Biologic and Pharmaceutical Strategy

Changes are in progress, with more to come, in both the US and EU. FDA’s Center for Devices and Radiological Health (CDRH) is undergoing a significant reorganization in terms of both personnel and office responsibilities. In the EU, the new Medical Device Regulation will take effect in less than a year. RAPS invited Allison Komiyama, PhD, RAC, and expert on the US device environment, and John Beasley, RAC, whose primary focus is EU devices, to discuss those changes and their impact on device manufacturers.

RAPS Podcast #2 - Changes in Device Regulation

With Dr. Elaine Morrato, Associate Dean for Public Health Practice and Professor in Health Systems Management and Policy at the Colorado School of Public Health, and visiting scientist at FDA’s Office of Surveillance and Epidemiology Dr. Morrato joins RAPS senior editor Pam Jones for an insightful discussion on risk management, regulatory professionals’ role, REMS and its elements, and the translation of health innovation into practice. She also provides easily-accessible resources on the topic. Dr. Morrato has offered to answer any questions submitted on the topics discussed. To send questions for Dr. Morrato, please email RAPS at podcasts@raps.org

RAPS Podcast #1 - Risk Management

Welcome to RAPS podcasts. RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

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RAPS Podcasts

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