Regulatory Affairs Professionals Society (RAPS)

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.

Chemistry, manufacturing and controls (CMC) can make or break a drug's regulatory journey. Are you prepared for every st...
08/30/2026

Chemistry, manufacturing and controls (CMC) can make or break a drug's regulatory journey. Are you prepared for every stage?

At this two-day workshop on 2 and 3 November, Pat Cash and Soundview LLC’s Nicole Damour will provide an enhanced understanding of CMC principles for drug substance and drug product, with emphasis on requirements in the US, Europe and other highly regulated regions.

Get your ticket today: https://hubs.la/Q04vGGJ70

What makes a successful commercial product launch? And what role should regulatory and quality professionals play? Read ...
08/28/2026

What makes a successful commercial product launch? And what role should regulatory and quality professionals play?

Read this chapter from the just-released Global Medical Device Regulatory Strategy, Third Edition, and share your takeaways with other RAPS members as part of Regulatory Reading Club: https://hubs.ly/Q04vL9D00

Thank you to Flora Sandra Siami for her contributions to this chapter, and to the rest of the authors who contributed their expertise to this new book!

Let experts show you the path to securing regulatory approval for software as a medical device (SaMD). At this two-day w...
08/26/2026

Let experts show you the path to securing regulatory approval for software as a medical device (SaMD).

At this two-day workshop on 16 and 18 November, MedSec CEO Michelle Jump and NorMed Consulting’s Jonas A. Bundgaard will equip regulatory and quality professionals with strategic insights to help guide their organizations in navigating global software as a medical device expectations.

Get your ticket today: https://hubs.la/Q04vmC5g0

celebrates Don Boyer, a former chair of the RAPS Board of Directors who has served the regulatory affairs profession a...
08/26/2026

celebrates Don Boyer, a former chair of the RAPS Board of Directors who has served the regulatory affairs profession as a leader, regulator, and volunteer.

Learn more about Don: https://hubs.la/Q04twGY10

FDA is seeking feedback on a competency-based approach to regulating medical devices that utilize generative artificial ...
08/25/2026

FDA is seeking feedback on a competency-based approach to regulating medical devices that utilize generative artificial intelligence (GenAI).

This proposal was introduced in a discussion paper in which the agency seeks feedback on its proposed approach. The paper defines GenAI as “a class of AI models that emulate the structure and characteristics of input data in order to generate derived synthetic content. This can include images, videos, audio, text, and other digital content.”

Joanne Eglovitch reports for Regulatory Focus: https://hubs.ly/Q04vbnPy0

The more things change, the more regulatory affairs professionals have to keep up. The RAPS 50th Anniversary Sale is you...
08/25/2026

The more things change, the more regulatory affairs professionals have to keep up.

The RAPS 50th Anniversary Sale is your chance to take advantage of exclusive discounts on courses, books, and more.

Deals expire at midnight ET on 27 August.

Explore today: https://hubs.la/Q04v6TRT0

Kinda chic 🤷‍♀️
08/24/2026

Kinda chic 🤷‍♀️

Wearables exist in a regulatory gray zone that is “becoming one of the most consequential decisions companies make, but ...
08/19/2026

Wearables exist in a regulatory gray zone that is “becoming one of the most consequential decisions companies make, but that it is one of the least understood,” says Priya Setty.

At , she, Attrayee Chakraborty, Alina-Andreea Mihai, Mingxiang Xu, and Aneesh Deoras will combine perspectives from regulatory, quality, manufacturing, notified body, and FDA to examine how wearables are classified, positioned, and managed across jurisdictions.

Come for the one-of-a-kind speaker lineup.

Stay for the innovative Jeopardy-style format that will keep attendees and speakers on their toes.

Priya explains more in our interview: https://hubs.la/Q04tChvh0

President Donald Trump has named White House aide Heidi Overton to lead the FDA, he announced on Wednesday.Overton will ...
08/19/2026

President Donald Trump has named White House aide Heidi Overton to lead the FDA, he announced on Wednesday.

Overton will fill the position previously held by Marty Makary, who left the agency in May. Her nomination is subject to confirmation by the Senate.

Joanne Eglovitch has more in Regulatory Focus:
https://hubs.la/Q04tC7vR0

celebrates Dan Mannix, has served the regulatory affairs profession as a volunteer, author, and more. Learn more about...
08/19/2026

celebrates Dan Mannix, has served the regulatory affairs profession as a volunteer, author, and more.

Learn more about Dan: https://hubs.la/Q04twHN90

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5635 Fishers Lane, Suite 400
Rockville, MD
20852

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