Essentials and Overview of the Regulatory Framework in Europe 2020

Essentials and Overview of the Regulatory Framework in Europe 2020 is a conference dedicated to the European regulatory system for human medicines.

Topics

• 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