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), 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.

One inspection strategy doesn't fit every market. Medical device manufacturers face different inspection requirements, p...
09/14/2026

One inspection strategy doesn't fit every market. Medical device manufacturers face different inspection requirements, priorities, and practices across the FDA, EU notified bodies, MDSAP, China’s NMPA, Korea’s MFDS, and Japan’s PMDA.

At this workshop on 27 October, Grace F. Palma, Christine Forcier, Viki Chen, Jimin Choi, Noemi Portillo Schambach, and Kim Trautman will take a practical, cross-regional look at what manufacturers need to know to prepare regulatory professionals like yourself for inspections.

Get your ticket today to strengthen your inspection readiness strategy: https://hubs.ly/Q04vZnVS0

Want to pursue a career in regulatory affairs? An FRA credential is your key to proving your introductory knowledge.Lear...
09/11/2026

Want to pursue a career in regulatory affairs? An FRA credential is your key to proving your introductory knowledge.

Learn more about the FRA, including our new credentials designed to prove your global regulatory strategy knowledge: https://hubs.la/Q04wqmNw0

The current medical device QMS standard ISO 13485: 2016 does not address the specific requirements of a cyber device. At...
09/11/2026

The current medical device QMS standard ISO 13485: 2016 does not address the specific requirements of a cyber device.

At this workshop on 11 November, Cochlear’s Jyotsna Yadav will show you how to:

💡Understand whether compliance to which standard and specific clauses are necessary for meeting FDA cybersecurity guidelines
💡 Understand the current QMS standard is equipped to deal with cyber devices
💡 Comprehend the likely harmonization considerations in the majority regions on cybersecurity

Get your ticket today: https://hubs.la/Q04vYGzS0

celebrates Rainer Voelksen, who has served the regulatory affairs profession in industry, as a regulator, as chair of ...
09/10/2026

celebrates Rainer Voelksen, who has served the regulatory affairs profession in industry, as a regulator, as chair of the RAPS Board of Directors, and more.

Learn more about Rainer: https://hubs.la/Q04x9-x10

Can AI be validated when its output can change from one model update to the next?FDA's Computer Software Assurance (CSA)...
09/10/2026

Can AI be validated when its output can change from one model update to the next?

FDA's Computer Software Assurance (CSA) guidance introduced a more efficient, risk-based approach to software validation. However, applying that framework to AI introduces a new set of challenges such as model drift, prompt sensitivity, and non-deterministic outputs.

In this webinar on 24 September, Ketryx's Bailey Canter will explore how to apply CSA's risk-based principles to AI in regulated processes — including a real-world example of a validated AI agent for requirement conflict detention.

Join us to learn and explore what AI validation looks like in practice: https://hubs.la/Q04vZv7K0

Combination products are transforming healthcare. Is your regulatory strategy keeping pace? The DIA/RAPS Fundamentals o...
09/10/2026

Combination products are transforming healthcare.

Is your regulatory strategy keeping pace?

The DIA/RAPS Fundamentals of Combination Products Workshop provides a practical introduction to the regulatory landscape governing combination products in the US, European Union, and key global markets.

Whether you’re new to combination products or looking to strengthen your existing knowledge, this workshop will help you build a stronger foundation for navigating the regulatory considerations that impact development and submissions.

📅 9-11 December
⏱️ 9:00 AM – 12:30 PM EST

Early bird pricing ends 9 November.

Start building the knowledge you need to navigate combination product regulation with greater confidence: https://hubs.la/Q04wSkQt0

ePI, eCTD v4.0, and structured chemistry, manufacturing, and controls (CMC) may be moving on separate timelines—but they...
09/09/2026

ePI, eCTD v4.0, and structured chemistry, manufacturing, and controls (CMC) may be moving on separate timelines—but they are all part of the same bigger shift.

At this webcast on 23 September, Docuvera’s Murali Menon will explore how these evolving requirements come together around one goal: structured, reusable, and traceable content that can move efficiently through regulatory submissions.

Get your ticket today: https://hubs.la/Q04vYYsb0

A strong regulatory intelligence function starts with knowing where to look, what matters, and what to do with what you ...
09/08/2026

A strong regulatory intelligence function starts with knowing where to look, what matters, and what to do with what you find.

At this workshop on 9 November, Florence Healthcare’s Sara Saunders and Kim Gallop will give regulatory professionals practical, scalable strategies to identify high-value, trustworthy resources, build low-cost approaches for tracking decisions and structuring intelligence.

Register here: https://hubs.la/Q04wWSby0

💡Only 3 days left to save on the RAPS Fall 2026 Advanced Strategic Communications Certificate Program! Ready to strength...
09/06/2026

💡Only 3 days left to save on the RAPS Fall 2026 Advanced Strategic Communications Certificate Program!

Ready to strengthen your strategic communications skills and expand your influence in the regulatory environment?

The Advanced Strategic Communications Certificate Program is designed for professionals looking to:

- Advance their career in regulatory communications
- Build confidence communicating with leadership and stakeholders
- Strengthen strategic communications expertise
- Develop skills to navigate complex communications challenges

Don't miss the opportunity to invest in your professional development while saving on registration.

Register by 9 September to save: https://hubs.la/Q04vmW-K0

“RCC” isn’t just a set of letters you put after your name. It’s a demonstration of real-world EU MDR or IVDR knowledge.A...
09/04/2026

“RCC” isn’t just a set of letters you put after your name. It’s a demonstration of real-world EU MDR or IVDR knowledge.

Apply for the final RCC exam window of 2026 by 24 September: https://hubs.la/Q04wrc8w0

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5635 Fishers Lane, Suite 400
Rockville, MD
20852

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