Conversation Starters

Conversation Starters – New for 2023!
Sessions tagged as “Conversation Starters” are main conference sessions that offer a Solutions Circle (which may occur before or after main session) that takes a deeper dive of its topic. Attendance of the main conference session is not required to attend the Solutions Circle.

*Program and facilitators subject to change. Please check back frequently for updates.

Conversation Starters

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Monday, Oct 2nd
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 WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Monday, Oct 2nd
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 WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Monday, Oct 2nd
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 WorkshopBiopharmaceuticals (includes Biologics and Drugs)
Tuesday, Oct 3rd
8:30 AM - 4:00 PM EDT
Drug Development in EU: Regulatory Standards, Support and New Approaches
Location/Room: 510B
Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Presenter: Karl-Heinz Huemer, PhD MD – khhconsult
Presenter: Sabine Haubenreisser, MSc, PhD, FRAPS – European Medicines Agency
Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
Presenter: María Concepción Prieto Yerro, MD, PhD – Malta Medicines Authority
Presenter (Remote): Matthias Dormeyer, MD – Granzer Regulatory Consulting & Services GmbH
Presenter: Daniela Drago, PhD, RAC, FRAPS – NDA Partners
Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)
Tuesday, Oct 3rd
8:30 AM - 4:00 PM EDT
IVDR Technical Documentation Pre-conference Workshop
Location/Room: 511F
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Presenter: Tom Patten – NSAI
Presenter: Catherine Holzmann – GMED Certification Division
Presenter: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Tuesday, Oct 3rd
8:30 AM - 4:00 PM EDT
PRRC – A New EU Requirement
Location/Room: 510A
Workshop Leader: Bassil Akra, phD – Akra Team GmbH
Presenter: Danielle Giroud, MSci – MD-CLINICALS SA
Presenter: Keith Morel, PhD – Qserve Group
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
Presenter: Erik R. Vollebregt – Axon Lawyers
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)
Tuesday, Oct 3rd
8:30 AM - 4:00 PM EDT
US Regulatory Essentials for Devices and IVDs
Location/Room: 511E
Presenter: David Chadwick, PhD, RAC, FRAPS – Independent
Presenter: Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A.
Presenter: Etienne Nichols, PMP, CSM – Greenlight Guru
Presenter: Tony Blank – AtriCure, Inc.
Presenter: Christie Hughes, MPH, MLS(ASCP) – Qserve Group
Presenter (Remote): Larry Pool – Cook Incorporated
Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)