North Jersey Section
American Chemical Society

Regulatory CMC and Quality Topical Group

The Regulatory CMC group fulfills a need for increased local cross-industry networking and discussion on critical regulatory CMC (Chemistry / Manufacturing / Controls), quality assurance, and compliance issues – centered here in the pharmaceutical belt of New Jersey.

The mission of The Regulatory CMC is to provide a forum for regulatory and compliance scientists to exchange ideas, share strategies, discuss current topics, increase our knowledge and understanding of CMC regulatory affairs, quality assurance, and cGMPs.

If you would like to take an active role in planning the next event for our new group, or would just like to share your comments or suggestions, please feel free to get in touch. We look forward to hearing from you!

Contact us at asingh.njacs@gmail.com

Chair
Shankar Swaminathan
shankar.swaminathan@bms.com

Secretary
Siva Prasad
siva.prasad@bms.com

Treasurer
Ambarish Singh
asingh.njacs@gmail.com

2011 Regulatory-CMC Symposium

“Topics of Current Interest in Regulatory-CMC”

Venue: Fiber Optics Auditorium on the Busch campus
Rutgers University, Piscataway, NJ
Date: September 22, 2011

Download the flyer.

  • Pre-registration is recommended. Deadline is Fri, Sept 16, 2011.
  • Registration fee: General $15.00; students, retirees etc. $10.00
    Online registration payment is appreciated:
  • 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

David Ziering, Director, Bristol-Myers Squibb Co.

“Genotoxic Impurities in Pharmaceuticals: A Regulatory Perspective”

02:00 – 03:00 pm

Matthew Lamb, Sr. Director, Warner Chilcott

“Regulatory Assessments and Strategic Planning: Key Considerations for Global Drug Development”

03:00 – 03:15 pm

Break

03:15 – 04:15 pm

Steven R. Peltier, Vice President, Corporate Reg Affairs, Integra Life

“Off Label Promotion – General vs Specific Claims”

04:15 – 05:15 pm

Ravi Kalyanaraman, Senior Scientist, Bristol-Myers Squibb Co.

“Combating ‘Fake Pharmaceuticals’ Using PAT”

05:30 pm

Adjourn

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