CMC Special Interest Network
Overview and summary of activities
TOPRA CMC SPIN
The CMC Special Interest Network (SPIN) was formed for TOPRA members in February 2006 to provide a forum for regulatory affairs professionals working in the field of Chemistry and Pharmacy and associated GMP issues in human and veterinary medicine. It currently has approximately 100 members from small and large pharmaceutical companies; independent consultants, human health and veterinary medicine, and regulators. The membership covers a wide range of experiences, from those relatively new to the field to those with many years of experiences.
The aim of the group is to raise the profile of RegCMC in pharmaceutical R&D and the regulatory process, thereby promoting the role of Regulatory CMC (RegCMC), to facilitate common understanding by means of discussion groups and education and to facilitate RegCMC education and training in collaboration with the activities of TOPRA’s conference and educational working parties. The group provides an active e-mail network in which members can raise regulatory questions to draw on the broad knowledge of the network members and gain rapid, valuable feedback on their experiences. Exchanges of information cover a variety of CMC topics, from leading edge, novel and challenging issues to those considered more routine. Network members can provide a fresh view on a topic and valuable support to less experienced members.
In addition, a series of teleconferences and/or face to face meetings are arranged throughout the year to invite discussion on technical topics of interest e.g., clinical trials, genotoxic impurities and QbD approaches to name but a few. In 2008, the group scheduled discussions on global CMC changes and variations, drug substance master files and associated topics, requirements for sterile products in the EU and US and international regulatory CMC requirements. Members are encouraged to raise technical topics, contribute questions and actively participate in the discussions.
The group also recently contributed to a CMC focused edition of the Regulatory Rapporteur (July/August edition 2008).
If you wish to get to know colleagues in other companies and sectors of the industry, gain from their experience and actively participate in our discussions then the CMC SPIN would like to hear from you! Our only criterion for joining is that you are a member of TOPRA.
Click here to access the CMC Members' Area.
Membership contact:
e-network: TOPRACMCNet
To become a TOPRA member please click here.
