PASS studies
 

Friday, 8. October 2021, 14:00 - 15:30

Webinar

Post-authorisation safety studies (PASS)

A post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing their results.

The purpose of the information in PASSs is to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making. They aim to:

  • identify, characterise or quantify a safety hazard;
  • confirm the safety profile of a medicine, or;
  • measure the effectiveness of risk-management measures.

PASSs can either be clinical trials or non-interventional studies.

Het programma van het evenement zal bekend worden gemaakt via de nieuwsbrief en op de website.

Deelname
Deelname voor leden van DARQA is gratis. Aan dit evenement kunnen niet-DARQA-leden deelnemen na overschrijving van € 25,- op de bankrekening van DARQA NL 61 ABNA 0245 9984 46 o.v.v. Webinar PASS studies en NAAM. De overschrijving van € 25,- moet uiterlijk woensdag 6 okt 2021 ontvangen zijn door DARQA. 

 

Graag willen wij je verwelkomen op deze DARQA bijeenkomst, meld je nu aan voor deelname

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