Europharm SMC Workshop on "How to choose the optimal registration route for medicines in the EU?"
As you certainly know, there are different procedures to obtain approval for a medicinal product in the EU.
During this workshop you will have an overview of the procedures and the various pathway. The decision on which regulatory pathway to use will depend on the nature of the active sustances, the target indication(s) , the history of the product and/or the marketing strategy.
Interesting questions will be raized:
- Are you aware of the three pathways to register medicines in the EU?
- Do you know when it is mandatory to follow the Centralized Procedure (CP) ?
- Are you aware about the importance of the choice of the reference member state (RMS) in terms of timing and costs?
- Do you know and understand the role of the EMA Coordination Group for MRP and DCP human (CMDh)?
- Do you know which are the most recommended RMS?
- Are you aware of the importance of market access analysis in the registration process?
If the answer to these questions is not obvious for you we recommend you to participate to this workshop which will have a very practical orientation and will definitely help you make the right decisions.
You'll find the program and the registration form here below.