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Monday, October 2, 2023
6:30 AM – 10:00 AM
EDT
Speaker Ready Room Open
6:30 AM – 10:00 AM
EDT
Speaker Ready Room Hours
Location/Room: 512C
6:30 AM – 4:00 PM
EDT
Registration Open
6:30 AM – 4:00 PM
EDT
Registration Hours
7:00 AM – 8:00 AM
EDT
Preconference Workshops: Breakfast & Networking for Registrants
7:00 AM – 8:00 AM
EDT
Preconference Workshops: Breakfast & Networking for Registrants
8:00 AM – 8:30 AM
EDT
Preconference Workshops: Welcome Workshop Registrants!
8:00 AM – 8:30 AM
EDT
Preconference Workshops: Welcome Workshop Registrants!
8:30 AM – 4:00 PM
EDT
Common pitfalls in Manufacturer technical documentation submissions to Notified Bodies; Ways to overcome these
8:30 AM – 4:00 PM
EDT
Common Pitfalls in Manufacturer Technical Documentation Submissions to Notified Bodies; Ways to Overcome These.
Location/Room: 511F
Presenter:
Purvi S. Patel, PhD, CEng, MIMechE
– BSI Group
Presenter:
Vishal Thakker, MEng
– BSI Group
Presenter:
Rachel Mead, BEng MIET
– BSI Group
Presenter:
Alexey Shiryaev, MD PhD
– DNV Product Assurance AS
Presenter:
Gareth Enright, MEng
– National Standards Authority of Ireland
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
8:30 AM – 4:00 PM
EDT
Communication toolkit for a successful regulatory compliance strategy
8:30 AM – 4:00 PM
EDT
Communication Toolkit for a Successful Regulatory Compliance Strategy
Location/Room: 510A
Presenter:
Corinne Delorme, MS, RAC
– nexialist
Presenter:
Vincent Castéras, PhD
– nexialist
Presenter:
Florianne Torset-Bonfillou, MS, RAC
– GMED North America
Preconference Workshop
Devices (includes Medical Devices and In Vitro Diagnostics)
8:30 AM – 4:00 PM
EDT
What are the requirements for an IND submission?
8:30 AM – 4:00 PM
EDT
What are the Requirements for an IND Submission?
Location/Room: 510B
Workshop Leader:
Hagit Marchaim, PhD MBA
– HMC-Regulation
Presenter:
Lina Jamis, MS
– Synthego Corporation
Presenter:
Tyler C. Vandivort, PhD, RAC, DABT
– Amplicore Inc
Preconference Workshop
Biopharmaceuticals (includes Biologics and Drugs)
10:30 AM – 11:00 AM
EDT
Preconference Workshops: Networking Break for Workshop Registrants
10:30 AM – 11:00 AM
EDT
Preconference Workshops: Networking Break for Workshop Registrants
12:30 PM – 1:30 PM
EDT
Preconference Workshops: Lunch & Networking for Registrants
12:30 PM – 1:30 PM
EDT
Preconference Workshops: Lunch & Networking for Registrants