CMC Management in Regulatory Affairs -
von FORUM Institut für Management GmbH
Quality data for marketing authorisation in Europe
- Regulatory requirements in the EU and the ICH region - Essential quality data for marketing authorisation - CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary - Management of post-approval changes - Classification of quality related variationsThis course will give you an in-depth knowledge on the CMC requirements for the marketing authorisation.
This training course will give you in-depth knowledge of CMC requirements for marketing authorisation. Our experts will address essential quality data and provide strategic information on CMC writing and maintenance.
This seminar addresses the needs of those working in the pharmaceutical industry. It will particularly benefit CMC managers, regulatory affairsmanagers and managers of the quality assurance department dealing with the - compilation and the maintenance of Module 3 of the CTD, - classification of quality-related changes.