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Challenges and Opportunities in Developing Drug Substance and Product CMC Dossiers: CTD Submissions
Sunday, November 11
8:30 am – 4:00 pm
Short Course
ACPE #073-999-07-501-L04
This short course is targeted to better understand and define drug substance and drug product CMC necessary for US and European marketing authorization(s). Presentations will include "recommendations” on drug substance and drug product CMC information, per the current current Guidances, along with industry and FDA perspectives. Overall, this short course should help in developing a better understanding of FDA and EMEA expectations in developing the Quality/CMC sections of CTD submissions.
Moderators
Sanjay Sehgal, Ph.D.
Wyeth Pharmaceuticals
Vijay Tammara, Ph.D.
Merck and Company, Inc.
Global API and Product Stability Requirements
Nirdosh K. Jagota, Ph.D.
Wyeth Pharmaceuticals
Quality-by-Design: Leveraging Regulatory Flexibility
Sanjay Sehgal, Ph.D.
Wyeth Pharmaceuticals
Integrating Dosage Form Design and Development With Manufacturing Process
Syed Shah, Ph.D.
Wyeth Pharmaceuticals
Genotoxic Impurities: Technical-Regulatory Strategies for Successful Submissions
David Ziering, Ph.D.
Bristol-Myers Squibb Co.
Analytical Methods Development, Validation and Transfers
Robert Bell, Ph.D.
Drug and Biotechnology Development, LLC
Global Registrations: Challenges and Harmonization Opportunities
Charles Hoiberg, Ph.D.
Pfizer, Inc.