“Topics of Current Interest in Regulatory-CMC”

Thursday, December 2, 2010
Raritan Valley Community College, Bridgewater, New Jersey
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  • 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


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

05:30 pm