An Essential Guide To Eu Regulatory Affairs 2013

Topics

• Scientific advice procedure
• EU Regulatory Legislative Framework
• The impact of paediatric investigational plans and how to plan for the best possible outcome
• What areas should you focus on and what are the potential pitfalls
• What are the timings and thresholds
• How to manage the orphan drug designation procedure
• The impact of the Centralised Procedure for registering medicinal products in the EU
• The importance of the Risk Management Plan