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Breakthrough innovations in medicinal based therapies as well as technological device developments have led to the rapid rise in the use of combination products. Risk management is important as it underpins the success of development, manufacturing, post market surveillance, and lifecycle management of advanced therapies. Alignment with regulators for efficient regulatory pathways is critical for predictable outcomes. In this session, we review:
Integration of Medicinal and Medical Device Quality Risk Management approaches for successful combination product development and lifecycle management.Insights and best practices for combination products in the EU, discussing both clinical trial applications and Notified Body experience.Evolving innovations in the combination product space.The evolving FDA regulatory landscape supporting innovative new combination products.
10:00 - 10:25: Combination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019 by Susan Neadle 10:25 - 10:45: Lifecycle Management of Notified Body Opinions- A Streamlined Approach by Lori-Anne Boville 10:45 - 11:00: Disruptive Medicine Innovations- Next Generation Combination Products by James (Jim) Wabby 11:00 - 11:20: Combination Products through the Eyes of the FDA by Steven Hertz 11:20 - 11:30: Question and Answer/Panel Discussion moderated by Susan Neadle
Speaker(s):
Lori-Anne
Boville,
Group Director, Pharma Technical Regulatory, Device and Combination Products,
Genentech Inc.
Steven
Hertz,
MBA, PE,
Consumer Safety Officer, Office of Pharmaceutical Quality,
CDER/FDA
Susan
W. Neadle,
FRAPS, FAAO,
President,
Combination Products Consulting Services LLC
James
Wabby,
Global Head, Regulatory Affairs,
AbbVie, Inc.
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