In 2003 The New Jersey Regulatory and Quality Topical Group was formed under the umbrella of the North Jersey Section of the American Chemical Society (NJACS) . This 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 New Jersey Regulatory and Quality Topical Group is to provide a forum for regulatory and compliance scientists in the metropolitan New Jersey area to exchange ideas, share strategies, discuss current topics, increase our knowledge and understanding of CMC regulatory affairs, quality assurance, and cGMPs, and promote the importance of our fields.
The first event of this new topical group, entitled "An Afternoon of Regulatory CMC and Quality Topics" was held at the Madison Hotel on June 12, 2003. Four speakers were featured, spanning a mixture of regulatory and quality assurance topics. Two of the speakers previously worked at FDA and traveled from the Washington, DC area to bring their insights to the meeting. The meeting attendees also represented a wide range of fields including quality assurance, regulatory affairs, pharmaceutical and chemical development, and analytical chemistry. The response to the meeting and the formation of the topical group was highly enthusiastic.
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. I look forward to hearing from you!
Sincerely,
Orin Tempkin
Novartis Pharmaceuticals Corp.
