North Jersey Section
American Chemical Society

2010 Regulatory-CMC Symposium

“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

Program

12:15 – 12:45 pm
Registration

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
Break

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

05:30 pm
Adjourn