North Jersey Section of the ACS

Chair - Shankar Swaminathan

Secretary - Siva Prasad

Treasurer - Ambarish Singh

NJ Regulatory CMC and Quality Topical Group

[ current | register | history | past meetings ]

Next Meeting:

September Regulatory-CMC Symposium

Thursday, September 22, 2011

(Please note: This symposium was originally scheduled for June but posponed to September.)

At the Fiber Optics Auditorium on the Busch campus
Rutgers University, Piscataway, NJ

“Topics of Current Interest in Regulatory-CMC”

[ registration | directions | flyer ]

12:15 - 12:45 PM


1:00 - 2:00 David Ziering, Director, Bristol-Myers Squibb Co.

“Genotoxic Impurities in Pharmaceuticals: A Regulatory Perspective”

2:00 - 3:00 Matthew Lamb, Sr. Director, Warner Chilcott

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

3:00 - 3:15


3:15 - 4:15 Steven R. Peltier, Vice President, Corporate Reg Affairs, Integra Life

“Off Label Promotion – General vs Specific Claims”

4:15 - 5:15 Ravi Kalyanaraman, Senior Scientist, Bristol-Myers Squibb Co.

“Combating ‘Fake Pharmaceuticals’ Using PAT”

5:30 PM




  • 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:

    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

    For maps and directions at the Rutgers website, please [ click here ]


Registration will open this summer for the
September Regulatory-CMC Symposium on Thursday, Sept 22, 2011

Dr/etc  First  Last
Phone (required)
I plan to pay by: (required)
Email (required)
Area of Interest
Current Occupation

STOP: Please review the data above for accuracy, before Submitting

Contact for more information:



Regulatory-CMC and Quality Group: Background

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.

The first event of this new topical group, entitled “TopicsTopics of Current Interests in Regulatory-CMC” was held on Dec 2, 2010 at the Raritan Valley Community College.

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!


Shankar Swaminathan
Siva Prasad
Ambarish Singh