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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

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6:30 AM – 4:00 PM EDT
Registration Open

6:30 AM – 4:00 PM EDT

Registration Hours

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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

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8:00 AM – 8:30 AM EDT
Preconference Workshops: Welcome Workshop Registrants!

8:00 AM – 8:30 AM EDT

Preconference Workshops: Welcome Workshop Registrants!

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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)

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Purvi S. Patel, PhD, CEng, MIMechE (she/her/hers) – BSI Group ### 1950306###Presenter###Regulatory Lead###BSI Group###
Presenter: Purvi S. Patel, PhD, CEng, MIMechE (she/her/hers) – BSI Group
### she/her/hers @@@ Vishal Thakker, MEng (he/him/his) – BSI Group ### 1614543###Presenter###Head of UK Approved Body & Senior Regulatory Lead###BSI Group###
Presenter: Vishal Thakker, MEng (he/him/his) – BSI Group
### he/him/his @@@ Rachel Mead, BEng MIET (she/her/hers) – BSI Group ### 2016362###Presenter###Clinical Regulatory Lead###BSI Group ###
Presenter: Rachel Mead, BEng MIET (she/her/hers) – BSI Group
### she/her/hers @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###
Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
### @@@ Gareth Enright, MEng – National Standards Authority of Ireland ### 2074276###Presenter###Certification & Inspection Officer ###National Standards Authority of Ireland###
Presenter: Gareth Enright, MEng – National Standards Authority of Ireland
###

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)

Favorite

Corinne Delorme, MS, RAC – nexialist ### 1523467###Presenter###Regulatory Intelligence Director###nexialist###
Presenter: Corinne Delorme, MS, RAC – nexialist
### @@@ Vincent Castéras, PhD – nexialist ### 1543942###Presenter###CEO and Founder###nexialist###
Presenter: Vincent Castéras, PhD – nexialist
### @@@ Florianne Torset-Bonfillou, MS, RAC – GMED North America ### 579831###Presenter###Senior International Regulatory Project Manager ###GMED North America###
Presenter: Florianne Torset-Bonfillou, MS, RAC – GMED North America
###

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?

Proficiency: Foundational/ Operational/ Novice

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)

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Hagit Marchaim, PhD MBA (she/her/hers) – HMC-Regulation ### 1947145###Workshop Leader###Owner and principal consultant at Dr. Hagit Marchaim RA Consulting (HMC-regulation)###HMC-Regulation###
Workshop Leader: Hagit Marchaim, PhD MBA (she/her/hers) – HMC-Regulation
### she/her/hers @@@ Lina Jamis, MS (she/her/hers) – Synthego Corporation ### 2099003###Presenter###Associate Director, Regulatory Affairs###Synthego Corporation###
Presenter: Lina Jamis, MS (she/her/hers) – Synthego Corporation
### she/her/hers @@@ Tyler C. Vandivort, PhD, RAC, DABT (he/him/his) – Amplicore Inc ### 1546697###Presenter###Director Regulatory Affairs and Operations###Amplicore Inc###
Presenter: Tyler C. Vandivort, PhD, RAC, DABT (he/him/his) – Amplicore Inc
### he/him/his

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

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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

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