Spring Intro 2023

16/02/2023

Process

1 •PASS/PAES study proposed/imposed

2 •Seek Scientific Advice on study design (optional) 3 •Submit protocol & agree design (~60 days)

•Conduct study

4

•Submit interim results

5

6 •Submit results (CSR) to agency (Type II) 7 •Update product information/RMP as appropriate

•Update to EPAR

8

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Top Tips

• Results submitted within 12 months of study completion • Generally observational but recent developments are moving away from this • Resource intensive! Initiation and conduct can conflict with launch efforts • National Competent authorities have a say in the implementation of a PASS (as an RMM) • PAES tend to follow a more conventional approach as efficacy study

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