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PASS studies

Vrijdag, 08. Oktober 2021, 14:00 - 15:30


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.

Tijdens dit webinar zullen 2 presentaties in het Engels gegeven worden, daarom onderstaande tekst in het Engels.

This webinar is aimed at providing an overview for quality professionals working in the clinical and/or PV area of post-authorisation studies. This includes post-authorisation safety studies, with particular focus on the non-interventional studies and the variety of projects this can include.

Topics covered:

- What are the types of post-authorisation (safety) studies? 

- Why and when PA(S)S?

- What are the applicable (pharmacovigilance) requirements?

- When should a study be included in the PSMF and what are the safety reporting requirements? 

- How to approach audits of PASS studies and what challenges and findings you might face ?

Stuart Harris a Senior Manager in Clinical QA at Astellas and is based in the UK. 
He has worked in the Pharmaceutical industry for 30+ years mainly in clinical operational roles delivering phase 2 to 4 studies both regionally and in the UK affiliate (last 20 years at Astellas). In 2018 he moved into PVQA and subsequently into the CQA team. He has supported multiple MHRA Inspections.


Henrieke de Bie is currently working as Director PVQA at Astellas but will start her own QA consultancy company in the autumn of 2021, with a focus on clinical, PV and quality culture projects.
Henrieke has 20+ years of experience in the industry in different GxP areas, but primarily in the clinical and more recently also in the PV area. Most of the time she has worked in different international QA auditor, consultant and functional and strategic quality leadership roles. Henrieke has a biomedical background and completed an MSc study in Quality Management in Scientific Research and Development at the Cranfield University (UK) in 2018.



Presentaties door Stuart Harris and Henrieke de Bie, gevolgd door Q&A en discussie.
Uiteraard is er tijdens de webinar voldoende gelegenheid om vragen te stellen en/of je eigen ervaringen te delen. 


Deelname voor leden van DARQA is gratis. Aan dit webinar 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. 

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