e-Learning: EU Variation System and Procedures - Classification, Grouping, Worksharing & Submission

- Module 1: Overview of the EU law and Guidelines - including Commission Delegated Regulation (EU) 2024/1701 - Module 2: Classification of Variations - Module 3: Procedural Aspects of Variations - Module 4: Grouping and Worksharing - Module 5: Application Form et cetera - Bonus material - Module 5a: Live recording of a webcast on the electronic submission of variations (German language with English subtitles) - Module 6: Other Post-Authorisation ProceduresThis e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.LernzieleThis e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.- Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.- This e-Learning was updated June 2025. It covers all relevant updates introduced by Commission Delegated Regulation (EU) 2024/1701. - NEW: bonus material - live recording of a webcast on the electronic submission of variations from December 2024 (German language with English subtitles).ZielgruppenThis e-learning course is intended as an introduction to EU variations for anyone who needs to understand, classify or submit variations to the relevant agency, particularly those working in regulatory affairs. No prior experience with variations is required.