How do clinical study requirements for ATMPs differ from others?

[Rosa.Hart]

We are planning clinical studies for an ATMP. How do the requirements differ from other therapies, for instance instance small molecules? Especially regarding safety assessments and biodistribution studies?

[marlous.kooijman]

The following documents are good starting points for answering your questions:

• EMA guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials

• EMA Guideline on strategies to identify and mitigate risks for
  first-in-human and early clinical trials with investigational
  medicinal products

• ATMP guidebook for innovators in the Netherlands

@TMaxMos: do you have any additional suggestions?