- Module 1: Overview of the EU law and Guidelines - 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) - 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.
- Module 1: Overview of the EU law and Guidelines - Module 2: Classification of Variations - Module 3: Procedural Aspects of Variations - Module 4: Grouping and Worksharing - Module 5: Application Form ... Mehr Informationen >>
Lernziele
This 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 developed in December 2019 and updated 2023.- NEW: bonus material - live recording of a webcast on the electronic submission of variations (German language from March 2023)
This 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 comp ... Mehr Informationen >>
Zielgruppen
This e-learning course is intended for anyone working on variations, classifying or submitting them to the relevant agency, particularly those involved in regulatory affairs.