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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.
Updated by a group of distinguished regulatory experts, this new edition is a must-have handbook for regulatory professionals at all levels.
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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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
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.
In this edition, Regulatory Focus has brought together some of the top regulatory influencers from around the world—all with diverse experience—to offer their perspectives on how the shifting landscape and evolving regulatory approaches are impacting the regulatory profession today. With the need of regulatory science to keep pace with the changing global landscape, technological advancements, increased innovation and the complexity of the drug and device development process, the role of the regulatory professional has become ever more strategic. This insightful collection of articles illustrates the expanding strategic role of regulatory professionals and demonstrates the vital role regulatory plays within organizations and throughout the product lifecycle.
Inside the Series:
The Changing Role of the Regulatory Professional By Adriana Becker
How the Role of Regulatory Operations Professionals Will Evolve in the new Decade By Rachel Belani
Why Understanding Regulatory Affairs is Important to Key Company Decision Makers By Isabella Schmitt
Writing Informed Consents Documents: A Balancing Act By Viji Ramesh
Regulatory Affairs Consultants. Who needs them and why? By Steven J. Knapp, MS, PharmD and Andrew S. Verderame, MBA, RAC
Consultants: How to Hire and Engage for Success By David W. Husman, PhD, ASQ CPGP, RAC
Assessing Risk and Strategic Business Decision-Making Without Consistent FDA Enforcement By Kate Morris Jurcik
Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization By Kate Forte, MSc
Professional Development: Benefits of Obtaining Professional Qualifications By Orin Chisholm, GCULT, PhD, SFHEA
Regulatory Leadership for a Culture of Quality By Amaris Ajamil, PhD, RAC
Critical Thinking and Leadership Skills for Regulatory Professionals By Robert E. Yocher, MHSC, FRAPS
Access More Benefits With These Series
Here are the Series you Have to Look Forward to in 2020:
To Access Your Member Benefit, simply login and select the e-Book: RF Article Series: the Strategic Role of the Regulatory Professional 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.