Regulatory Affairs Professionals Society (RAPS)

06/12/2026

We want to know how RAPS can best support you!

Take our survey and let us know how RAPS can best serve you as a regulatory professional here: https://hubs.la/Q04lf2Ph0

Plus, every participant gets the chance to win a $250 Visa gift card!

06/12/2026

Quality culture is about creating a shared mindset where quality becomes a core value of your company, Kerri DiPietro told attendees at the .

Key elements to getting there:

💡A methodical and purposeful process
💡Getting buy-in from key leadership
💡Measuring the progress
💡 Implementing a plan that may take years to accomplish.

Ferdous Al-Faruque reports from Baltimore for Regulatory Focus: https://hubs.la/Q04ldTd20

06/11/2026

“More than 25 years after the ICH issued Guideline for Good Clinical Practice, those good clinical practice (GCP) principles are still sound and there is little to criticize,” Beat Widler and Peter Schiemann wrote in chapter 8, Quality Risk Management: A Gateway to Quality by Design, from our book Risk Management Principles for Devices and Pharmaceuticals.

Their chapter is this month’s selection for Regulatory Reading Club! This is a chance for RAPS members to come together and discuss a member-exclusive book chapter.

Read the chapter and share your takeaway here: https://hubs.la/Q04l5qP00

06/11/2026

Work with us to make the best it can be!
We are looking for volunteers to join the RAPS Euro Convergence Programme Committee. Responsibilities include:

💡Identifying content tracks for the conference
💡Reviewing all conference abstract submissions and, using a pre-selected rubric, selecting those that reflect excellence and innovation in regulatory work
💡Creating the conference agenda, based on the tracks and selected abstract
💡Participating in monthly committee calls beginning in September 2026, and one, 2-day in-person program planning meeting on 2-3 November in Barcelon
💡Providing session development support and serving as committee liaison for up to five sessions. Learn more here:

PURPOSE To develop themes and tracks and identify topics and speakers fo

06/10/2026

celebrates Mark Kramer, the founding director of FDA’s Office of Combination Products who has served the regulatory profession across several organizations, and as a RAPS board member and volunteer.

Learn more about Mark: https://hubs.ly/Q04kTNGF0

06/09/2026

Comparability protocols provide structured, pre-approved plans for managing postapproval chemistry, manufacturing, and controls changes while ensuring product quality.

In the Journal of Regulatory Affairs, Piyush Modi, Dhaval Desai, and Jigneshkumar Modasiya outline the scientific rationale for the proposed changes and analytical strategies and examine their advantages and limitations and differences between the FDA and EMA approaches.

RAPS members get exclusive access here: https://hubs.la/Q04kKb_90

06/09/2026

Ready to learn something new in regulatory affairs, but not sure what? Get some inspiration: https://hubs.la/Q04kNnK70

06/09/2026

We’re looking for volunteers to help us plan the RAPS Regulatory Intelligence Conference!

If you’re passionate about regulatory intelligence, this is your chance to serve the profession.

Apply by 12 June:

RAPS is seeking two (2) volunteers to join the RAPS Regulatory Intelligence Conference Committee.

06/09/2026

FDA has finalized a revised draft guidance from 2022 on what human factors information sponsors should include in premarket submissions for medical devices.

FDA recently published the final guidance, which includes additional risk-based factors that sponsors should consider when determining the human factors submission category, new examples in the appendices, and clarification about the scope of the guidance. While the guidance applies to marketing submissions for medical devices, including 510(k) premarket notifications, De Novo requests, and premarket approval submissions, the final guidance also addresses combination products.

"The recommendations in this guidance are intended to be generally applicable for all medical devices reviewed by [the Center for Devices and Radiological Health (CDRH)]," the agency added. "If there are device-specific guidances or requirements, the applicable recommendations should, and applicable requirements must, be followed."

Ferdous Al-Faruque reports for Regulatory Focus:

The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what human factors (HF) information sponsors should include in premarket submissions for medical devices.

06/08/2026

Help us plan the RAPS Global Regulatory Strategy Conference! We are looking for volunteers to join our conference planning committee, which ensures this event reflects the needs of the global regulatory strategy community and delivers a premier professional development and networking experience.

Apply by 12 June:

RAPS is seeking four (4) volunteers to join the RAPS Global Regulatory Strategy Conference Committe