Essensials of European Regulatory Affairs 2014 is a conference dedicated to actual registration systems available for approval of medicinal products, including
- Directive 2001/83/EC ‘the Community Code’ on the Mutual Recognition Procedures
- Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency
- Decentralised procedure and referrals
Topics include:
- Marketing Authorisation for Medicinal products in the EU
- The European Network and registration procedures
- Lifecycle Management
Who should Attend
Professionals in project management, regulatory affairs and product development.
