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Session 7: Regenerative Medicine and ATMPs: Combined Product Perspectives and Watch-Outs
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Advancements in cellular and molecular biotechnology has resulted in a new segment within biological medicinal products which has led to the development of Combined Advanced Therapy Medicinal Products (CATMPs). Although they offer ground-breaking treatments for unmet medical needs, these products also present challenges within the development and manufacturing space.
Learning Objective : At the conclusion of this session, the participant should be able to:- Identify combined stability and shelf-life program considerations and opportunities
- Outline best practices in drug delivery change control for post-approval evaluations
- Describe challenges and opportunities in lifecycle management programs for complex CATMPs
Speaker(s)
Regenerative Medicine and ATMPs: Combined Product Perspectives and Watch-Outs
Iris K. Marklein, PhD
FDA, United States
Biomedical Engineer
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