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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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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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 wide range of regulatory responsibilities and organizations. These quarterly electronic publications are developed for the benefit of RAPS’ Members.
Since the Q1 RF Series, the COVID-19 pandemic has significantly changed our world and not least, the global regulatory landscape. This collection of in-depth articles takes on an additional relevance in the prevailing disruption and uncertainly. It is a pleasure to bring together the voices of top regulatory experts from around the world as they share their insights and offer guidance on ensuring continuity in manufacturing and regulatory processes in an evolving regulatory landscape.
Inside the Series:
EU IVDR Changes Regulatory Landscape By Jordanna Jayne, MS, PhD Preparing for Virtual Regulatory Meetings By Jim DiBiasi, Cindy DiBiasi Optimizing Remote Internal Quality Audits By Tammy M. Pelnik, MS Electronic Platforms for Submission of Clinical Trial Information By Federico Bonacci, MD, Siegfried Schmitt, PhD, Moshe L. Reiss, MBA, MSN, RN, Viviana Mascilongo, PhD, Manuel Neukum, MBA, Daniel Sürder, MD Global Orphan Drug Regulation By Julie Watchorn, RAC Adopting Regulatory Intelligence and Strategy to Foster the Evolving Landscape By Jessica Schlegel, MS, Jessica L. Hale, PharmD, Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP, George A. Cusatis, MS, RAC, William Mejias, Dan Visco, Suraj Ramachandran, MS, RAC Economic Operators: Roles and Obligations Under EU’s MDR By Randolph Fillmore The Evolution of the China Regulatory Environment: Review and Update By Alistair Davidson, Guoliang Liu, Bill Wang The Changing Regulatory Landscape for Insulin: FDA and Congress Seek to Increase Pressure on Pricing By Charity Duran, PhD, RAC, Kathleen Candando, PhD, RAC Applying FDA’s Rules in the New World of Online Marketing and Crowd Funding By Suzanne Levy Friedman
Access more benefits in previous Series on the following topics:
Upcoming Series for 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.