How to prepare the submission dossier? Procedural and scientific advice - practical aspects - Péter Károlyi, Scientific Administrator, EMEA
Price: £40.00
Session 1
How to prepare the submission dossier? Procedural and scientific advice - practical aspects.
Péter Károlyi, Scientific Administrator, EMEA
Presentation followed by questions and answer session
- Defining applicable paediatric framework
- Letter of intent
- Templates
- Timelines
- Where to find procedural advice
- Examples for pitfalls in Part A of the PIP
- When and where to find paediatric data
- Scientific requirement
- Scientific experts
- Clinical experience
