Presents
Register nowAgenda
Please explore the 2024 agenda for an idea of what to expect in Providence.
October 8, 2024 @ 9:00 am
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5:15 pm
Other
Moderators
Chin-Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech/Roche
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 Love, Deputy Director, Office of Combination Products, FDA
Annette Marthaler, Senior Regulatory Counsel, Office of Combination Products, FDA
Stephanie Shapley, Associate Director for Policy, Office of Combination Products, FDA
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
Khaudeja Bano, Vice President Combination Product Quality, Ex Amgen
Fran DeGrazio, Principal Consultant, Strategic Parenteral Solutions LLC
James Wabby, Head – Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie Inc.
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 @ 10:25 am
–
11:25 am
Other
Moderators
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Chin-Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech/Roche
Speakers
October 9, 2024 @ 11:25 am
–
12:25 pm
Other
Moderators
Speaker
October 9, 2024 @ 1:40 pm
–
2:25 pm
Other
Moderators
Speakers
October 9, 2024 @ 2:25 pm
–
3:25 pm
Other
Moderator
Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie
Speakers
October 9, 2024 @ 3:50 pm
–
4:50 pm
Other
Moderators
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Tine Albeck, Senior QA Professional, ALK A/S
Speaker
Khaudeja Bano, Past Amgen
Sara Coon, Director Regulatory Affairs, Halozyme, Inc
Nik Thakur, Senior Program Manager, Quality and Compliance, Center for Devices and Radiological Health,(CDRH), FDA (Invited)
October 9, 2024 @ 4:50 pm
–
5:00 pm
Other
Moderator
Kim Belsky, Strategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
October 10, 2024 @ 8:00 am
–
8:10 am
Other
Moderator
Kim Belsky, Strategic 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
October 10, 2024 @ 9:10 am
–
10:10 am
Other
Moderator
Speakers
Isabelle Clamou, Policy Officer, European Commission
October 10, 2024 @ 10:35 am
–
11:20 am
Other
Moderators
Shannon Hoste, Chief Scientific Officer for Patient for Pathway Health
Speakers
October 10, 2024 @ 11:20 am
–
12:20 pm
Other
Moderator
Speakers
October 10, 2024 @ 1:20 pm
–
2:00 pm
Other
Moderator
Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie
Speakers
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
October 10, 2024 @ 3:00 pm
–
3:10 pm
Other
Moderator
Kim Belsky, Strategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative