Spring Intro 2023

16/02/2023

Considerations & Tips

• Fees for procedures: variation (paid) vs stand-alone PAM (free) • Cumulative letter of recommendations - EMA keep an overview of all recommendations [REC] and monitor how and when they have been addressed • Track commitments in a systematic way and remind stakeholders . Don’t assume your Company knows about them! • Scientific advice may be required to ensure fulfilment of a complicated PAM • PAMs have a deadline which must be abided by. If not - engage with regulators ASAP.

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PASS & PAES POST AUTHORISATION SAFETY STUDIES (PASS) & POST AUTHORISATION EFFICACY STUDIES (PAES)

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