Regulatory Affairs Professionals Society (RAPS)

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Regulatory Affairs Professionals Society (RAPS) Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Regulatory Affairs Professionals Society (RAPS), Nonprofit Organization, 5635 Fishers Lane, Suite 400, Rockville, MD.

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products.

Complex combination product regulations, explained by experts. Whether you’re new to combination products or looking to ...
10/26/2026

Complex combination product regulations, explained by experts.

Whether you’re new to combination products or looking to strengthen your regulatory knowledge, the DIA/RAPS Fundamentals of Combination Products workshop brings together experts from the FDA, EMA, notified bodies, and industry.

Explore the agenda and hear firsthand perspectives on key combination product topics through expert presentations, real-word case studies, and interactive discussions.

9-11 December | 9:00 AM – 12:30 PM ET

14 days left to save on early bird pricing.

View the full agenda: https://hubs.ly/Q04zhzTz0

FDA sent warning letters to two major healthcare product manufacturers—Baxter International and Olympus Medical Systems—...
10/26/2026

FDA sent warning letters to two major healthcare product manufacturers—Baxter International and Olympus Medical Systems—for good manufacturing practice and Quality System Regulation violations.

Both warning letters note that the firms were cited for repeat observations from previous interactions with the agency.

Joanne Eglovitch reports for Regulatory Focus: https://hubs.la/Q04C7K3M0

Thank you for helping our organization serve the needs of global regulatory and quality professionals đź’™.Earlier this yea...
10/25/2026

Thank you for helping our organization serve the needs of global regulatory and quality professionals đź’™.

Earlier this year, RAPS embarked on a study to understand how well RAPS is serving the needs of global professionals across regulatory and quality, and to inform our plans for the future.

Thank you to everyone who spent their time sharing your unique insights into the challenges, opportunities, and needs of regulatory and quality professionals.

Regulatory’s biggest event wouldn’t be possible without the important contributions of our Student Ambassadors! Thank ...
10/25/2026

Regulatory’s biggest event wouldn’t be possible without the important contributions of our Student Ambassadors!

Thank you for helping us serve the regulatory community đź’™.

5 DAYS LEFT!⌛ Are you ready for your next regulatory inspection? One inspection strategy won’t work for every market. F...
10/23/2026

5 DAYS LEFT!⌛ Are you ready for your next regulatory inspection?

One inspection strategy won’t work for every market. From the FDA and EU notified bodies to MDSAP, China’s NMPA, Korea’s MFDS, and Japan’s PMDA, inspection requirements and expectations can vary significantly.

Join Grace F. Palma, Christine Forcier, Viki Chen, Jimin Choi, Noemi Portillo Schambach, Kim Trautman, Rica Morris, and Ira Dave on 27 October for a practical, cross-regional workshop designed to help regulatory professionals strengthen inspection readiness and prepare for what lies ahead.

The workshop is just 5 days away. Secure your ticket today: https://hubs.la/Q04C8MRy0

Build your foundation in FDA requirements for prescription drug and biologic promotion, including claim substantiation, ...
10/23/2026

Build your foundation in FDA requirements for prescription drug and biologic promotion, including claim substantiation, promotional review, enforcement examples and social media.

- Start learning today: https://hubs.la/Q04zr9LH0

This week, celebrates Carol Cooper! She has served the regulatory profession as a regulatory director and manager, exp...
10/22/2026

This week, celebrates Carol Cooper! She has served the regulatory profession as a regulatory director and manager, expert consultant, RAPS Board member and volunteer, and RAPS chapter leader.

Learn more about Carol: https://hubs.la/Q04C4WgY0

Celebrating a productive discussion today between RAPS and Singapore’s Health Sciences Authority.Our organizations discu...
10/22/2026

Celebrating a productive discussion today between RAPS and Singapore’s Health Sciences Authority.

Our organizations discussed our shared priorities and the ways we can collaborate to support the regulatory profession.

We are excited about the opportunity for future collaborations and discussions!

Before the introduction of dedicated pediatric regulations in the late 1990s and early 2000s, a large proportion of medi...
10/22/2026

Before the introduction of dedicated pediatric regulations in the late 1990s and early 2000s, a large proportion of medicines used in children were prescribed off-label, leading to uncertainties in safety and dosing.

In the Journal of Regulatory Affairs, Samantha Gastine Nadia Boehringer, and Anne-Valérie Faucher examine how the EU and the US have developed distinct but complementary regulatory frameworks to address this issue: https://hubs.la/Q04xVs-10

All written by regulatory experts. All designed to help you bring safe and effective medical devices to the people who n...
10/21/2026

All written by regulatory experts. All designed to help you bring safe and effective medical devices to the people who need them.

Start reading today: https://hubs.la/Q04BZGhL0

(And yes, we have books on pharmaceuticals, biologics, combination products, and more at that link.)

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5635 Fishers Lane, Suite 400
Rockville, MD
20852

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