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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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
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
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.
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