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!
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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
12:15 – 12:45 pm
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
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”