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
Shankar Swaminathan
shankar.swaminathan@bms.com
Secretary
Siva Prasad
siva.prasad@bms.com
Treasurer
Ambarish Singh
asingh.njacs@gmail.com
(Past Events)
2011 Regulatory-CMC Symposium
“Topics of Current Interest in Regulatory-CMC”
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
Latest News
2021 Baekeland Award
The North Jersey Section of the American Chemical Society will award the 2021 Leo Hendrik Baekeland Award on May 12, 2022, to Dr Prashant K. Jain.
The Section presents the Award biennially to commemorate the technical and industrial achievements of Leo Hendrik Baekeland and to encourage younger chemists to emulate his example.
Message From Justyna Sikorska
It is a great honor to serve as Chair for 2023. I look forward to leading this incredible and diverse group of volunteers . . . My goals for 2023 start with supporting our diverse topical groups and committees in organizing exciting seminars . . .
