“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, phenadip.com 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
It is a great honor to serve as Chair for 2024. I look forward to leading this incredible and diverse group of volunteers . . . My goals for 2024 start with supporting our diverse topical groups and committees in organizing exciting seminars.