AFDO RAPS Healthcare Products Collaborative
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Agenda

Please explore the 2024 agenda for an idea of what to expect in Providence. 

October 8, 2024 @ 9:00 am

5:15 pm

Other

Moderators

Chin-Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech

Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi

Hemal Mehta, Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination, Johnson & Johnson

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie

Susan Neadle, Principal Consultant & President, Combination Products Consulting, LLC

October 8, 2024 @ 10:00 am

2:00 pm

Other

Speakers

James Bertram, Director, Office of Combination Products (OCP), U.S. Food and Drug Administration 

Patricia LoveDeputy Director, Office of Combination Products, FDA 

Annette MarthalerSenior Regulatory Counsel, Office of Combination Products, FDA 

Stephanie ShapleySenior Advisor, Office of Combination Products, FDA 

October 9, 2024 @ 7:00 am

8:00 am

Other

October 9, 2024 @ 8:00 am

8:30 am

Other

Moderator

Kim Belsky, Strategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative

October 9, 2024 @ 8:30 am

9:15 am

Other

Moderators

Fran DeGrazio, Principal Consultant, Strategic Parenteral Solutions LLC
Rich Wolf, Vice President of Client Relations, RxLogix Corporation 

October 9, 2024 @ 9:15 am

10:00 am

Other

Moderator

Kim Belsky, Strategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative

Speaker

James Bertram, Director of the Office of Combination Products (OCP), FDA
Danita Dixon, Associate Director for Information Management, Office of Clinical Policy & Programs, Office of the Commissioner, FDA

October 9, 2024 @ 10:00 am

10:25 am

Other

October 9, 2024 @ 10:25 am

11:25 am

Other

Moderators

Bonnie OdomPartner in the Healthcare and Life Sciences Practice, Epstein Becker & Green

Tine Albeck, Senior QA Professional, ALK A/S

Speaker

Nik Thakur, Senior Program Manager, Quality and Compliance, Center for Devices and Radiological Health,(CDRH), FDA (Invited)

October 9, 2024 @ 11:25 am

12:25 pm

Other

Moderators

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca
Rumi Young, Director, Regulatory Policy, Novo Nordisk

Speaker

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA 
Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

October 9, 2024 @ 12:25 pm

1:40 pm

Other

October 9, 2024 @ 1:40 pm

2:25 pm

Other

Moderators

Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Eli Lilly

Speakers

Brian Neely, Chemist, Center for Drug Evaluation and Research (CDER), FDA 
Andrew Fine, Senior Advisor in Division of Clinical Review in OGD, Center for Drug Evaluation and Research (CDER), FDA
Chirag Walawalkar, Director Device Design & Process Development, Merck (Invited)

October 9, 2024 @ 2:25 pm

3:25 pm

Other

Moderator

Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie

Speakers

Tina Kiang Director, Division of Regulation and Guidance (DRG), Office of Policy for Pharmaceutical Quality (OPPQ), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), FDA
Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health,(CDRH), FDA 
Chelsea O’Connell, Director, Global Regulatory and R&D Policy, Amgen
Jiaying Shen, Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck
Lisa Wright, Director of Regulatory Policy, Novo Nordisk

October 9, 2024 @ 3:25 pm

3:50 pm

Other

October 9, 2024 @ 3:50 pm

4:50 pm

Other

Moderators

Bonnie OdomPartner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Chin-Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech

Speakers

Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health,(CDRH), FDA (Invited)
Shruti Mistry, Assistant Director, Injection Devices Team, Center for Devices and Radiological Health (CDRH), FDA
Renato Ravanello, Senior Director, Device Development, Genentech
Nathalie Vandenkoornhuyse, Executive Vice President, Regulatory Affairs, Coherus

October 9, 2024 @ 4:50 pm

5:00 pm

Other

Moderator

Kim BelskyStrategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative

October 10, 2024 @ 7:00 am

8:00 am

Other

October 10, 2024 @ 8:00 am

8:10 am

Other

Moderator

Kim BelskyStrategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative

October 10, 2024 @ 8:10 am

9:10 am

Other

Moderators

Rumi Young, Director, Regulatory Policy, Novo Nordisk

Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Eli Lilly

Speakers

Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA
Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health,(CDRH), FDA
Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
Jiaying Shen, Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck
Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices, AbbVie

October 10, 2024 @ 9:10 am

10:10 am

Other

Moderator

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Speakers

Isabelle Clamou, Policy Officer, European Commission
Olga Tkachenko, Policy Officer, European Commission

October 10, 2024 @ 10:10 am

10:35 am

Other

October 10, 2024 @ 10:35 am

11:20 am

Other

Moderators

Susan Neadle, Principal Consultant & President, Combination Products Consulting

Speakers

Patricia Love, Deputy Director, Office Of Combination Products, FDA
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

October 10, 2024 @ 11:20 am

12:20 pm

Other

Moderator

James Wabby, Head, Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie

Speakers

Carolyn Dorgan, Director, Technical Services, Suttons Creek
Anjali Gupta, Director Regulatory Affairs – Cell Therapy Device Development, NovoNordisk
Andrea Gray, Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER), FDA
Alex Lyness, Business Development Director – Drug Delivery, TTP
Jerzy Wojcik, VP Regulatory and Quality Services, Edgeone Medical (CDMO)

October 10, 2024 @ 12:20 pm

1:20 pm

Other

October 10, 2024 @ 1:20 pm

2:00 pm

Other

Moderator

Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie

Speakers

James Bertram, Director of the Office of Combination Products (OCP), FDA 
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA
Jill Lee, Senior Director, Regulatory Policy, Novo Nordisk
Annette Marthaler, Senior Regulatory Counsel, Office Of Combination Products (OCP), FDA
Chelsea O’Connell, Director, Global Regulatory and R&D Policy, Amgen
Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA 

October 10, 2024 @ 2:00 pm

3:00 pm

Other

Moderators

Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi
Rumi Young, Director, Regulatory Policy, Novo Nordisk

Speaker

James Bertram, Director of the Office of Combination Products (OCP), FDA

October 10, 2024 @ 3:00 pm

3:10 pm

Other

Moderator

Kim Belsky, Strategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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