Variations in Europe - Practical Guidance on Classification, Submission and Current Regulatory Updates

- Variation Regulation & new Guideline - Classification and submission (including new features since 15.01.26) - Type IA Notification, Type IB and Type II Variations - Grouping and worksharing - Variation submission (eAF, CESP) - Quality-related variations: Changes in the production process, analytics, formulation and packagingVariation regulation, new classification guideline, eSubmission and variation management: All processes explained in this online course.LernzieleThis training will bring you the latest information in the planning, classification and submission of variations. All relevant changes related to the new Variation Regulation (applicable since 01.01.25) and Guideline (applicable since 15.01.26) will be discussed. - Day 1 addresses regulatory requirements in detail, particularly guidance documents, variation classification, use of the variation e-application form and organisation of grouping and worksharing.- Day 2 addresses the classification and handling of quality-related changes. Case studies on how to work with the new classification guideline and the Q&A paper will reinforce your knowledge.-ZielgruppenThis practical seminar is aimed at professionals who are new to variation management or who need a comprehensive update on the new variation framework, and who are involved in planning, preparing, or submitting variations. Basic knowledge of the EU Marketing Authorisation framework is required.- Employees in the following departments will particularly benefit from the seminar: - regulatory affairs - quality assurance - production