This is the must-attend training course for anyone needing to learn the essentials of European Regulatory Affairs – it has been extended to two days to include more topics, and it is kept up to date in minute detail by the experienced faculty.

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. In addition the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed. This will cover the different steps and timelines in the different procedures, the clock-stops, the compiling of questions etc.

An introduction regarding the lifecycle will be given by information in respect to pharmacovigilance, variations and renewals.

The course will cover the curernt registration systems available for approval of medicinal products:

Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency

Directive 2001/83/EC the Community Code on the Mutual Recognition Procedures

Decentralised procedure and referrals

What participants from previous course say:

“The workshop was very interesting and useful, we got to check how much we really understand the subjects we had listened to. Everything was very well organized and I have a feeling I gained the basic good knowledge that will be an excellent background for future learning”

“The lecturers were excellent, I can only say positive things about their teaching. I appreciate you have taken people from both sides, industry and regulatory, that way we could really gain the most of it”

What You Will Learn

The European Network

Marketing Authorisation for Medicinal products in the EU

Lifecycle Mana