The CMC Special Interest Group (SPIN) has been active for over a decade. CMC SPIN was initiated primarily to provide a forum for regulatory affairs professionals working in the field of Chemistry, Manufacturing and Controls (CMC) within human medicine. It currently has over 1600 members from across pharma industry and independent regulatory consultants, with experience of both synthetic and biological products. The membership covers a wide range of levels of experience, from those relatively new to the field to those with many years of experience. A steering group of 12 members coordinates the activities of CMC SPIN.
The primary aim of the group is to raise the profile of CMC in TOPRA, industry and in the broader external regulatory environment to facilitate;
a common understanding of CMC related matters by means of discussion groups and knowledge sharing
to facilitate CMC education and training in collaboration with the activities of TOPRA’s conference and educational working parties.
The group provides an active e-mail network (accessed from the TOPRA website), 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.
CMC ‘hot topics’ include for example; accelerated pathways, new modalities, continuous manufacturing, Q12 and new regulations from China. Network members can provide a fresh view on a topic and valuable support to less experienced members.
In addition, a series of Webinars and face- to- face meetings are arranged throughout the year to invite discussions on CMC topics of interest. Members are encouraged to suggest topics, contribute questions and actively participate in the discussions.
Chemistry, Manufacturing and Controls (CMC) SPIN Steering group
- Chair: Peter Eijgenhuijsen
- Michal Mista
- Lisa Pascoe
- Aileen Fisher
- Aine Kane
- Anita Murray
- Carla Sivori-O’Neill
- Peter Blakeney
- Sarah Fitzgerald
- Steve Wood
- Meike Vanhooren
- Angela Currie
- Per Niklasson
- Federica Rusmini