Full Schedule

7:00 AM – 4:00 PM PDT

Registration Hours

7:00 AM – 4:00 PM PDT

Wellness Room

7:00 AM – 4:30 PM PDT

Speaker Ready Room

7:00 AM – 5:00 PM PDT

First Aid Office & Hours

7:30 AM – 8:30 AM PDT

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

Preconference Workshops Only

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 1 of 2)

Workshop Leader: – COPIA Leadership

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Act’s Technical Documentation Requirements and how to integrate them into a Medical Device Regulation Submission

Workshop Leader: – BSI

Presenter: – BSI

Presenter: – TÜV SÜD Product Service GmbH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM PDT

Communicating with Agency Officials, Top Management, and Other Stakeholders for Gaining Alignment on Strategic Initiatives

Presenter: – DeRisio Group, LLC

Workshop Leader: – Compliance-Alliance, LLC

Presenter: – Johnson & Johnson MedTech, Vision

Preconference WorkshopOther

8:30 AM – 4:00 PM PDT

Drug Development in the EU: Regulatory Standards, Supports, and New Approaches

Workshop Leader: – Austrian Medicines and Medical Devices Agency

Presenter: – khhconsulting

Presenter: – Gilead Sciences

Presenter: – NDA Partners

Presenter: – European Medicines Agency

Presenter: – Malta Medicines Authority

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

8:30 AM – 4:00 PM PDT

Sharpening Your Regulatory Soft Skills Toolbox

Workshop Leader: – Wolters Kluwer UpToDate, Inc.

Presenter: – Lumos Diagnostics

Presenter: – Regulatory Affairs Professionals Society (RAPS)

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

Survivor: The FDA 510(k) Program Edition (Day 1 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

3:00 PM – 3:15 PM PDT

Afternoon Break for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only