FSRM Training | European Regulatory Context for Pharma
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FSRM | Discover the European Union’s pharmaceutical regulations
The course, organised by the FSRM, will take place on 22 and 23 June 2020 in Neuchâtel. The course’s official language is French.
With more than 500 million inhabitants, the European Union is an essential market for the pharmaceutical industry, all the more attractive since its pharmaceutical regulations are globally harmonised.
- Understand the regulatory structure of the European Union
- Acquire a practical overview of the evaluators’ expectations for the development of a new drug and the submission of its registration
- Understand the obligations linked to obtaining the MA
The course will focus on all aspects of European regulations concerning the drug’s life cycle:
- non-clinical and clinical studies
- pharmaceutical development
- marketing authorisation application drafting
- submission procedures
- post-marketing authorisation variations
- and pharmacovigilance