Meetings/Workshops on Regulation in Medicine and Pharmacology in Germany

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1.
 
CMC Documentation & Post-Approval Changes/Variations
ID
854576
Dates
22 Mar 2017 - 23 Mar 2017
Location
Frankfurt, NH Frankfurt Niederrad, Germany
Abstract
Do you work in regulatory affairs/CMC or quality assurance? Then you shouldn’t miss out on this event. This conference will address very practical questions and provide strategic information on future CMC trends. Join the in-depth discussion on new developments, including: requirements for drug substance and drug product, elemental impurities and stability, ASMF worksharing, GMP inspection and QP declaration, quality documentation of IMPs, quality risk management, management of post-approval CMC changes and much more.
Contact
Laura Vogelmann;     Phone: [+49 6221 500-655];     Email: l.vogelmann@forum-institut.de
Topics
quality management, regulatory affairs, vigilance, drug substance and drug product in Module 3, how to implement ICH Q3D?, ASMF worksharing, QP declaration and GMP inspection, post-approval change management, CMC part of the IMPD

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Last updated: 06 December 2016