European Regulatory Affairs
June 3-4, 2019 in Basel
The course will give an overview of the European regulatory system for human medicines, including the legislative processes and European networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. Different steps and timelines for the various procedures will be covered. An introduction to pharmacovigilance, variations and renewals will be given in the context of the lifecycle. In addition, the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed.
for ECPM students: reduced price of 725 Eur and students (with no employment) for 300 Eur.
Please fill in the registration form (Company: ECPM Student with/without employment) and send it to Basel@DIAglobal.org