RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Regulatory Manager: What Senior Management Needs to Know About CMC Regulatory Compliance for Biotec

Regulatory Manager: What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products Part 2: Clinical Transition From Phase 2 to Phase 3

Posted 01 September 2009

The transition from Phase 2 clinical trials (studies to evaluate the effectiveness of the drug for a particular indication in patients) to Phase 3 clinical trials (expanded studies intended to gather the additional information about effectiveness and safety needed to evaluate the overall risk/benefit relationship of the drug) is a major milestone for a biotech company. An effective regulatory compliance strategy is critical at this stage to ensure that all chemistry, manufacturing and controls (CMC) activities necessary for eventual market approval are being planned for and any identified CMC impediment is under discussion with the regulatory authorities.

 

© 2022 Regulatory Affairs Professionals Society.