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Lessons Learned in the Development and Registration of Fixed-Dose Combination Products: CMC Focus
Session Chair(s)
Chandra Vemavarapu, PHD
Associate Director, Bristol-Myers Squibb Company, United States
Hear from industry and regulatory experts on best practices for development and registration of combination products in this forum.
Learning Objective : Discuss current trends in the development of fixed-dose combination products including guidelines, challenges, and opportunities; Describe best practices in the development and registration of combination products; Influence continuous improvement in the regulatory framework around combination products.
Speaker(s)
Xiling Song, MS
Senior Quality Product Leader, Genentech, A Member of the Roche Group, United States
Global Regulatory Framework and the CMC Challenges and Considerations for Fixed-Dose Combbinations
George Lunn, PHD
Chemist, ONDQA, OPS, CDER, FDA, United States
FDA Perspective
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