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 Registrants: Networking Breakfast & Welcome

8:00 AM - 4:30 PM EDT

RAPS Store Hours

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)

RAPS Competency Framework Proficiency Level: Advanced

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

Workshop Leader: – Compliance-Alliance, LLC

Workshop Presenter: – Speicher Regulatory Services

Workshop Presenter: – Regulatory Affairs Professionals Society (RAPS)

Workshop Presenter: – Ascendis Pharma

Workshop Presenter: – NDA Partners

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

RAPS Competency Framework Proficiency Level: Intermediate

Workshop Leader: – Kenai Therapeutics

Workshop Presenter: – Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Workshop Presenter: – Parexel

Workshop Presenter: – NDA Partners

Workshop Presenter: – Malta Medicines Authority

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

Devices (including Medical Devices & In Vitro Diagnostics)

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

Devices (including Medical Devices & In Vitro Diagnostics)

10:30 AM - 11:00 AM EDT

Preconference Workshops Registrants: Networking Break

12:00 PM - 4:00 PM EDT

Leadership Roundtable (by invitation only)

12:30 PM - 1:30 PM EDT

Preconference Workshops Registrants: Networking Lunch

1:00 PM - 4:00 PM EDT

Volunteer Leader Summit

3:00 PM - 3:15 PM EDT

Preconference Workshops Registrants: Networking Break

3:00 PM - 4:00 PM EDT

Student Career Development Sesson

Presenter: – University of North Carolina Chapel Hill

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

Networking