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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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
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.
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.
RI is a cornerstone of the regulatory landscape, and evidence-based information and the tools for monitoring and gathering it, are its prized components. RI professionals are regulatory sleuths, key players in pulling together that evidence to shape the policies, legislation, regulations, and guidelines regulators use in strategizing for drug development, approval, and product maintenance. In this series, a number of global regulatory affairs specialists write on aspects of regulatory intelligence that would help product developers stay current with the latest requirements and achieve their development goals in a timely, cost-effective manner.
Inside the Series:
Advanced therapies: Navigation and application of EU and US guidelines during product development By Kirsten Messmer, PhD, RAC, and Richard Dennett, PhD FDA warning letters in 2020 reveal concerns around purity and data integrity By Sarah Tanksley, MS, and Audrey Francis Regulation of cell and gene therapy products in China By Yingying Liu, MSc Current China NMPA clinical pathways for medical device registration By Grace Fu Palma, MBA, Jason Zhang, MD, Xiaolian Zou, and Beibei Xing, PhD Regulatory tools for generic drug companies: Formal FDA meetings and controlled correspondence By Sonal Jagani, MS, RAC EU regulatory tools for RA professionals By Maria E. Donawa, MD US-focused regulatory toolbox: The basics By Thomas Padula Starting out: A beginner’s toolkit of US regulatory resources By Holly Korzendorfer, PhD Adopting regulatory intelligence strategies to foster the evolving landscape By Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP, George A. Cusatis MS, RAC, Jessica L. Hale, PharmD, Jessica Schlegel, MS, and Suraj Ramachandran, MS, RAC Access more benefits in previous Series on the following topics:
Upcoming for 2021
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.