We are currently writing a product development plan for an ATMP towards phase I clinical studies. We are wondering if there are formats and guidances document for writing a product development plan for an ATMP or formats and guidances document for writing an IMPD specifically for ATMPs we can use as a basis and or starting point.
@marcel_hoefnagel, would you be able to share some of your knowledge and expertise?
As a start it would be good to take a look at the recently published guideline:
https://www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical-trials-scientific-guideline
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I hope I have highlighted some of the relevant aspects in the Webinar last Tuesday:
Product and Process characterisation for sufficient understanding. Using that you can identify Critical Quality Attributes and Critical Process Parameters. Based on that you can set up a Control Strategy. Even for a IMPD you need to have a basic understanding of your product and process and show that the process is under control and yields a product of the quality you intend to have.
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