Essentials and Overview of the Regulatory Framework in Europe 2018 is a conference dedicated to the European regulatory system for human medicines.
Essentials and Overview of the Regulatory Framework in Europe 2018 covers topics such as:
- The different routes for obtaining a licence for the European market
- Legislative processes and European networks
- The national procedures
- The centralised, the decentralised and the mutual recognition procedures
- Introduction to pharmacovigilance, variations and renewals in the context of the lifecycle
- Different steps and timelines for the various procedures
- The specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products