Current Guideline Revisions in CMC - Understanding and applying new regulatory developments - from stability to ICH M4Q (R2)

- Revision planning for ICH guidelines and update on the current status - Revision of the Variation Regulation - New CTD structure for the quality dossier: ICH M4Q (R2) - Implementation of ICH M4Q(R2) in practice - Update on the innovations introduced by ICH Q1 and ICH M13B as well as M13A - Draft ICH Q3E and Concept Paper ICH 6A/B - Regulatory Intelligence: How can RA/CMC prepare for the innovations?CMC in transition: Successfully implementing guideline updates - what CMC managers need to know now! Benefit from the expertise of our two experts and plan strategically.LernzieleHow do you keep track of the numerous guideline changes?- This seminar provides you with a compact, understandable overview of current and upcoming revisions in the CMC environment and saves you valuable time when analysing new requirements. You will recognise regulatory changes early on so that you can plan strategically.With practical case studies and direct implementation aids for guidelines such as ICH M4Q(R2) and the new Variation Regulation, you will strengthen your confidence in the regulatory environment.ZielgruppenThe seminar offers practical knowledge for - CMC Managers - Regulatory Affairs Professionals and - Quality Managers,who want to strategically prepare for upcoming regulatory requirements in drug development/approval.