Phact supported a start-up company in outlining a regulatory strategy that was planned to be discussed with the EMA’s multidisciplinary expert team, the Innovative Task Force, ITF).
A start-up company is confronted with the following situations:
- Lack of knowledge about regulatory requirements for advanced therapy medicinal products (ATMPs)
- Disagreement between different departments on how to proceed with product and process development
- Non-routine manufacturing process
- Lack of experience with authority meetings
Lack of knowlege about
regulatory requirements for ATMPs
Lack of experience with authority meetings
Missing regulatory strategy
How to Proceed?
The question is – what next steps should be taken in ATMP development? The solution is to draw up regulatory strategy for the specific product and discuss it with the EMA’s Innovative Task Force team.
The following measures are taken
- Application for a briefing meeting at EMA / Innovative Task Force (ITF)
- Preparing the briefing documentation
- Training of staff in preparation of the briefing meeting
- Presentation of the envisaged regulatory strategy
- Evaluation of the meeting outcome and initiating the next steps
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