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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
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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.
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.
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.
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