High-level introduction into Regulatory Affairs in the EU (basics only)
- Why medicines need to be regulated
- Interfaces of Regulatory Affaris department in pharmaceutical industry
- Pharmaceutical Product Lifecycle
- Principles for the authorisation process of medicinal products in the EU
- Structure and content of marketing authorisation dossier
- Legal base (types of applications in the EU)
- EU approval processes (i.e. national, CP, MRP, DCP
- EU post-approval processes (e.g. variations, renewals)