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Lessons Learned in the Development and Registration of Fixed-Dose Combination Products: CMC Focus

Track:
Pharmaceutical Quality

Day & Time:
June 17, 3:30PM - 4:30PM (Pacific Standard Time)

Session Number:
297

Room Number:
5A

Level:
Intermediate

Type:
Forum

Title:
Lessons Learned in the Development and Registration of Fixed-Dose Combination Products: CMC Focus

Chair(s):
Chandra Vemavarapu, PhD
Associate Director
Bristol-Myers Squibb Company, United States

Description:
Hear from industry and regulatory experts on best practices for development and registration of combination products in this forum.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Global Regulatory Framework and the CMC Challenges and Considerations for Fixed-Dose Combbinations
Xiling Song, MS
Associate Regulatory Program Director, Pharma Technical Regulatory
Genentech, Inc., United States

FDA Perspective
George Lunn, PhD
Chemist, ONDQA, OPS, CDER
FDA, United States