North Jersey Section of the ACS

Chair - Shankar Swaminathan

Secretary - Siva Prasad

Treasurer - Ambarish Singh

NJ Regulatory CMC and Quality Topical Group

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Past Meetings:

2010 Regulatory-CMC Symposium

Thursday, December 2, 2010

Raritan Valley Community College, Bridgewater, New Jersey

“Topics of Current Interest in Regulatory-CMC”

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12:15 - 12:45 PM Registration
1:00 - 2:00 Xin Du, Director, Regulatory and Compliance CMC Biologics - Bristol-Myers Squibb Co.

Approval Pathway for Biosimilar and Interchangeable Biological Products

2:00 - 3:00 Satyam Upadrashta, Executive Director, Forrest Labs

Drug Master Files in Regulatory Affairs
3:00 - 3:15 Break
3:15 - 4:15 Declan Kelly, Executive Director, Bristol-Myers Squibb Co.

Changes in EU Regulations
4:15 - 5:15 Beth Kendsersky, Director, Pfizer

Application of QbD Concepts and PAT for Real Time Release Testing
5:30 PM Adjourn

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Registration

  • 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:

    Choose Type:  
  • 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

Maps & Directions

  • The College's driving directions are here: www.raritanval.edu/about/directions.html
  • The Symposium will be held in the Conference Center, Building 11, in Conference Room B. Parking lots 1 and 2 can be used for parking. If you have special need for parking closer to the Conference Center, please contact the organizers.

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