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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.
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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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