Full Schedule

7:00 AM - 4:30 PM EDT

Speaker Ready Room Hours

7:00 AM - 7:30 PM EDT

Registration Hours

7:30 AM - 8:30 AM EDT

Preconference Workshop Networking Breakfast & Welcome

8:30 AM - 4:00 PM EDT

Preconference Workshop: Briefing Books that Work: A Storyboarding Method for Meetings, Scientific Advice, and AdComs (Day 2 of 2)

Workshop Leader: – Moderna, Inc.

Workshop Presenter: – Eldridge Writing & Consulting

Workshop Presenter: – Parexel International

Workshop Presenter: – Ultragenyx Pharmaceutical

Workshop Presenter: – Astrazeneca

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Claiming Your Seat at the Table

Moderator: – Speicher Regulatory Services

Presenter: – Compliance-Alliance, LLC

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Ethics in Action: Practical Tools for Navigating Regulatory Dilemmas

Moderator: – Qserve Group

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Navigating Cell & Gene Therapy US, EU, and Japan Regulatory Strategies

Presenter: – Kenai Therapeutics

Pharmaceuticals (includes Biologics and Drugs)

8:30 AM - 4:00 PM EDT

Preconference Workshops: Regulatory Leadership Bootcamp: A Skills‑Based Accelerator for Early to Mid‑Career Professionals

Workshop Leader: – Integrated Project Management

Workshop Presenter: – APS Pharma Solutions, LLC

Workshop Presenter: – UCB Pharma

Workshop Presenter: – Integrated Project Management

Workshop Presenter: – Biodesix, Inc.

Workshop Presenter: – AstraZeneca

Workshop Presenter: – Regulatory Affairs Professional

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Survivor: The FDA 510(k) and De Novo 50Th Anniversary Program Edition (Day 2 of 2)

Moderator: – DuVal & Associates, P.A.

Presenter: – DuVal & Associates, P.A.

Presenter: – DuVal & Associates

Presenter: – Intuitive

Medical Devices

8:30 AM - 4:00 PM EDT

Preconference Workshop: The Ins and Outs of the Commission's MDR and IVDR Targeted Revision Proposal (Day 2 of 2)

Workshop Leader: – Axon Lawyers

Workshop Presenter: – Akra Team

Workshop Presenter: – QServe Group

Workshop Presenter: – TÜV SÜD Medical Health Services

Medical Devices

10:30 AM - 11:00 AM EDT

Preconference Workshops: Networking Break

12:30 PM - 1:30 PM EDT

Preconference Workshops: Networking Lunch

3:00 PM - 3:15 PM EDT

Preconference Workshops: Networking Break

3:00 PM - 4:00 PM EDT

Student Career Development Sesson

Student FocusSkill Building

4:30 PM - 6:00 PM EDT

RAPS Convergence 2026 Welcome & Opening Plenary

6:00 PM - 7:30 PM EDT

Opening Networking Reception & Welcome in the Exhibit Hall