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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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
Convergence 2020 has come and gone, but you can still access recorded sessions, which are available to attendees until 31 December 2020.
This year, our European regulatory community will converge online with a fully virtual program that will allow attendees to experience Euro Convergence live online from the safety and comfort of their homes.
RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
The last exam window of 2020 is currently open. Register by 8 October to take the RAC exam this autumn.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Your Latest RAPS Member Benefit is here
RAPS is pleased to bring you another edition of its Regulatory Focus Article Series, comprised of timely and relevant technical articles, case studies, interviews, and research reports. These topic-focused collections are intended to benefit RAPS members responsible for healthcare-related products. Articles are developed by global subject-matter experts representing a range of regulatory responsibilities and organizations. These quarterly electronic publications are developed for the benefit of RAPS’ Members.
Regulatory affairs is a fluid and challenging field, even when we’re not weathering a global pandemic. No matter the area of specialty – regulatory pathways and processes, manufacturing, clinical trials, or regulatory oversight and guidance – there is constant pressure to balance staying current and timely delivery with longer-term, creative strategizing. In this series, we bring together the voices of top global regulatory experts who their share insights and advice on addressing challenges through early and deliberate strategizing.
Inside the Series:
A military-civilian perspective on real-world evidence to support regulatory decision making By Todd E. Rasmussen, MD, and Brian J. Young, MBA Outsourcing in regulatory operations By Jen Multari, MSc, RAC Interacting with competent authorities during COVID-19 – A European perspective By Anna Baran, MD, and Stephanie Geiger, PhD The Canadian application process and alternate pathway for COVID-19‒related clinical trials By Mukesh Kumar and Melanie Oakley Managing uncertainty: Regulatory reporting in multinational trials during COVID-19 By Ioana Ionita, MA Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers By Ginny Hu, PhD, and Neeta Sharma, MS Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers By Neeta Sharma, MS, and Ginny Hu, PhD Latin America market opportunities for food supplements: Navigating regulatory complexities By David Pineda Ereño, LLM Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy By Manfred Ruthsatz, PhD, Emmanuelle Voisin, PhD, Nelson Lima, PhD, and Kathleen D’Hondt, PhD Recasting CAPA as a continuous improvement process By Kathryn Merrill Designing a biologics manufacturing facility: Early planning for success By Mo Heidaran, PhD, R. Heath Coats, MS, and Steve Winitsky, MD Access more benefits in previous Series on the following topics:
Upcoming Series 2020
To access your member benefit, simply login and select the e-Book ‒ RF Article Series: The Shifting Global Regulatory Landscape ‒ in the Member Knowledge Center.
Not a RAPS Member? RAPS’ Membership gives you access to countless resources and a vast network of professional all dedicated to regulatory. Learn More About RAPS Membership and Benefits.