“Topics of Current Interest in Regulatory-CMC”
Thursday, December 2, 2010
Raritan Valley Community College, Bridgewater, New Jersey
Download the flyer.
- Pre-registration is recommended. Deadline is Wednesday, Nov. 25, 2010.
- Registration fee: General $15.00; students, retirees etc. $10.00
Online registration payment is appreciated:
- Please register [ below ]. On-site registration allowed but not preferred (cash or check only, no credit card). Please make your check or money order payable to the North Jersey Section of the ACS
12:15 – 12:45 pm
01:00 – 02:00 pm
Xin Du, Director, Regulatory and Compliance CMC Biologics – Bristol-Myers Squibb Co.
Approval Pathway for Biosimilar and Interchangeable Biological Products
02:00 – 03:00 pm
Satyam Upadrashta, Executive Director, Forrest Labs
Drug Master Files in Regulatory Affairs
03:00 – 03:15 pm
03:15 – 04:15 pm
Declan Kelly, Executive Director, Bristol-Myers Squibb Co.
Changes in EU Regulations
04:15 – 05:15 pm
Beth Kendsersky, Director, Pfizer
Application of QbD Concepts and PAT for Real Time Release Testing