Full Schedule

7:00 AM – 4:30 PM PDT

Speaker Ready Room

7:00 AM – 7:00 PM PDT

Wellness Room

7:00 AM – 7:30 PM PDT

Registration Hours

7:00 AM – 8:00 PM PDT

First Aid Office & Hours

7:30 AM – 8:30 AM PDT

Networking Breakfast & Welcome for Preconference Workshops Registrants (Workshop Registrants Only)

Facilitator: – RAPS

Preconference Workshops Only

8:00 AM – 5:00 PM PDT

RAPS Wellness Challenge

Networking Opportunity

8:00 AM – 5:00 PM PDT

Event App Support Desk Hours

8:00 AM – 6:00 PM PDT

RAPS Store Hours

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 2 of 2)

Workshop Leader: – COPIA Leadership

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

Basics of Regulatory Strategy for the US & EU for Devices (includes Medical Devices and In Vitro Diagnostics)

Workshop Leader: – Veeva Systems

Presenter: – Philips

Presenter: – TÜV SÜD Medical Health Services

Presenter (Remote): – EMA

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM PDT

Maximizing Opportunities to Engage With the FDA

Workshop Leader: – BioMarin Pharmaceutical, Inc.

Workshop Leader: – Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration

Presenter: – BOLDAPPROVALS

Presenter: – FDA/CDER

Presenter: – ORMRR/OTP/CBER/FDA

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

8:30 AM – 4:00 PM PDT

MDR Surveillance, Post-Certification and Re-certification Submissions to Notified Bodies: Best Practice for Manufacturers

Workshop Leader: – BSI

Presenter: – BSI

Presenter: – DNV Product Assurance AS

Presenter: – LNE-GMED-UK

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM PDT

Strategy and Regulatory Intelligence (RI) Primer: How to Construct and Maintain it Using AI Tools

Presenter: – Regulatorium

Presenter: – Recursion Pharmaceuticals, Inc.

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

Survivor: The FDA 510(k) Program Edition (Day 2 of 2)

Proficiency: Foundational/ Operational/ Novice

Presenter: – DuVal & Associates, P.A.

Presenter: – RQM+

Presenter: – Histosonics

Presenter (Remote): – FDA/CDRH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

10:30 AM – 11:00 AM PDT

Networking Break for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

12:30 PM – 1:30 PM PDT

Networking Lunch for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

2:30 PM – 3:30 PM PDT

Career Development Session for Students

Moderator: – RAPS

Presenter: – Lindsey Regulatory Affairs Consulting, LLC

Presenter: – Elemed

Presenter: – Qserve Group

Guest Speaker: – Northeastern University

Student Focus

3:00 PM – 3:15 PM PDT

Afternoon Break for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

4:30 PM – 5:00 PM PDT

Convergence 2024 Welcome!

Presenter: – Qserve Group

Presenter: – Regulatory Affairs Professionals Society (RAPS)

Presenter: – Thermo Fisher Scientific

Presenter: – Pfizer

Sponsor Speaker: – Celegence

Networking Opportunity

Supported By

5:00 PM – 6:00 PM PDT

RAPS Convergence 2024 Opening Plenary Session: Cross-Industry Insights: Leveraging AI to Elevate NextGen Regulatory

Moderator: – Thermo Fisher Scientific

Panelist: – MedSec LLC

Panelist: – City of Long Beach

Panelist: – Recursion Pharmaceuticals, Inc.

Panelist: – Epstein, Becker & Green

Networking Opportunity

6:00 PM – 7:30 PM PDT

Opening Reception & Welcome in the Exhibit Hall

Networking OpportunityExhibit Hall