The Centre for Education Programmes offers recordings of past webinars
1. Submission of documents and data in Module 3 (Quality) of the marketing authorisation application
2. Requirements for the pharmacokinetics report of the medicinal product bioequivalence study
3. Recommendations for the format and contents of the patient information leaflet (package insert) according to the EAEU requirements
4. Recommendations for the format and contents of the Summary of Product Characteristics (SmPC) according to the regulatory procedure for registration dossier alignment with the EAEU requirements
5. Dossier validation for medicinal product authorisation. EAEU requirements for the dossier format and contents
6. EAEU requirements for preclinical studies of medicinal products
7. Comparison of approaches to stability studies in the Russian Federation and EAEU. Requirements and common mistakes
8. Rules for biosimilar evaluation and authorisation in the Russian Federation
9. How to use your Applicant Account
10. Requirements for analytical method transfer and validation/verification parameters in the context of medicinal product evaluation
11. Updates on EAEU marketing authorisation procedures/rules for medicinal products for human use
12. Updates on EAEU safety evaluation and marketing surveillance procedures for medicinal products for human use
13. Requirements for medicinal product labelling and packaging mock-ups: common mistakes
14. Management of individual safety reports: collection, processing, and submission to the regulatory authorities
