Full Schedule

6:30 AM – 4:00 PM EDT

Speaker Ready Room Hours

Location/Room: 512C

6:30 AM – 7:00 PM EDT

Registration Hours

Location/Room: Level 2 Registration Foyer

7:00 AM – 8:00 AM EDT

Preconference Workshops: Breakfast & Networking for Registrants

Location/Room: Level 5 Foyers

7:00 AM – 6:00 PM EDT

Event App Support Desk Hours

Location/Room: Level 2 Registration Foyer

8:00 AM – 8:30 AM EDT

Preconference Workshops: Welcome Workshop Registrants!

Location/Room: Level 5 Foyers

8:00 AM – 6:00 PM EDT

RAPS Store Hours

Location/Room: Level 2 Registration Foyer

8:30 AM – 4:00 PM EDT

Drug Development in EU: Regulatory Standards, Support and New Approaches

Location/Room: 510B

Presenter: – Austrian Medicines and Medical Devices Agency

Presenter: – khhconsulting

Presenter: – Spanish Agency for Medicines and Medical Devices

Presenter: – European Medicines Agency

Presenter: – Malta Medicines Authority

Presenter (Remote): – Granzer Regulatory Consulting & Services GmbH

Presenter: – NDA Partners

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

8:30 AM – 4:00 PM EDT

IVDR Technical Documentation Pre-conference Workshop

Location/Room: 511F

Presenter: – TUV Sud GmbH

Presenter: – NSAI

Presenter: – GMED Certification Division

Presenter: – BSI Group The Netherlands B.V.

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM EDT

PRRC – A New EU Requirement

Location/Room: 510A

Workshop Leader: – Akra Team GmbH

Presenter: – MD-CLINICALS SA

Presenter: – Qserve Group

Presenter: – DNV Product Assurance AS

Presenter: – Axon Lawyers

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM EDT

US Regulatory Essentials for Devices and IVDs

Location/Room: 511E

Presenter: – Independent

Presenter: – DuVal & Associates, P.A.

Presenter: – Greenlight Guru

Presenter: – AtriCure, Inc.

Presenter: – Qserve Group

Presenter (Remote): – Cook Incorporated

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

10:30 AM – 11:00 AM EDT

Preconference Workshops: Networking Break for Workshop Registrants

Location/Room: Level 5 Foyers

12:00 PM – 6:30 PM EDT

Press Office Hours

Location/Room: 512F

12:30 PM – 1:30 PM EDT

Preconference Workshops: Lunch & Networking for Registrants

2:30 PM – 3:30 PM EDT

Career Development Session for Students

Location/Room: 513F

Presenter: – Qserve Group

Presenter: – Elemed

Presenter: – Qserve Group BV

Presenter: – MEDIcept

Presenter: – University of Southern California

3:00 PM – 11:59 PM EDT

Wellness Challenge

Location/Room: Level 2 Registration Foyer

Networking Opportunity

3:30 PM – 4:00 PM EDT

Student Career Development Meet and Greet

Location/Room: 513F

4:30 PM – 6:00 PM EDT

RAPS Convergence 2023 Welcome & Opening Plenary Session: The Futuristic Regulatory Professional

Location/Room: 220B

Facilitator: – Velvet Chainsaw Consulting

Guest Speaker: – Regulatory Affairs Professionals Society (RAPS)

Guest Speaker: – Planning Committee Chair Convergence 2023

Moderator: – Thermo Fisher Scientific

Guest Speaker: – Qserve Group

Panelist: – European Medicines Agency

Panelist: – Cedience Inc.

Panelist: – Principled Impact

Panelist: – Health Canada

Panelist: – United States Food and Drug Administration

6:00 PM – 7:00 PM EDT

Opening Reception in Exhibit Hall

Location/Room: Exhibit Hall

Networking Opportunity

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