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Combination Products Summit 2023

Combination Products Summit 2023

Committee

The Combination Products Summit program is carefully curated by experts across the healthcare products industry to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. We thank them for their hard work and dedication to this important event.

Stiina
Aarum

European Medicines Academy

Scientific Officer, Scientific Advice and Protocol Assistance

Khaudeja
Bano

Amgen

Vice President, Combination Product Quality

James
Bertram

FDA

 Director, Office of Combination Products

Francis
Blacha

Eli Lilly and Company 

Senior Vice President of Quality

Fran
DeGrazio

Strategic Parenteral Solutions

Principal Consultant

Ryan
Hoshi

AbbVie

Director, Regulatory Policy and Intelligence

Jason
Lipman

Sanofi

Senior Director, Global Regulatory Affairs, Device and Combination Products

Ryan
McGowan

AstraZeneca

Director, Digital Devices and Combination Products

Hemal
Mehta

Johnson & Johnson

Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products

Susan
Neadle

Combination Products Consulting

Principal Consultant & President

Thinh
Nguyen

FDA

Director, Office of Clinical Policy and Programs

Bonnie
Odom

Epstein Becker & Green, P.C.

Partner in the Healthcare and Life Sciences Practice

Tine
Schroder-Albeck

ALK A/S

Senior Quality Assurance Professional

Jiaying
Shen

Merck

Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality

Chin-Wei
Soo

Genentech/Roche

Global Regulatory Head – Devices and Combination Products

James
Wabby

AbbVie

Global Head – Emerging Technologies, Combination Products, and Devices

John (Barr)
Weiner

FDA

Associate Director for Policy, Office of Combination Products

Rich
Wolf

RxLogix Corporation

Vice President of Client Relations

Rumi
Young

Novo Nordisk

Director, Regulatory Policy

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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© 2024 AFDO/RAPS Healthcare Products Collaborative