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, 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 You Will Learn
Who Should Attend
Professionals in regulatory affairs, project management and product development.
At the conclusion of this course, participants should be able to:
Explain the European Network and registration procedures
Describe the concepts of marketing authorisation and regulatory data protection
Discuss the key issues that impact the choice of the registration procedure
Describe the lifecycle management
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
Hotel & Travel
This course will take place at:
Hotel NH Musica
van Leijenberghlaan 221
1082 GG Amsterdam
Tel: +31 20 79 56 088
DIA room block expired on 20 May 2014. Please contact the hotel for the availability and the best price.
HOW TO GET THERE: From Schiphol Airport, take the Sprinter Lighttrain toward Amsterdam RAI, Almere Oostvaarders or Hilversum. You will arrive at the the RAI train station in 10-14 minutes. From the RAI train station, take bus 62 toward Station Lelylaan and get off at the Bouvigne stop. Continue on Van Nijenrodeweg on foot and then turn left onto Van Leijenberglaan. The hotel will be on your left.
Tel: +41 61 225 51 51
Fax: +41 61 225 51 52