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Post-Authorisation Safety Studies (PASS)

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Date: 21-Sep-15 to 22-Sep-15
Location: TRYP Berlin Mitte / Berlin / Germany
Category: Healthcare & Pharmaceuticals Conferences & Trade Fairs

A PASS may be initiated, managed or financed by a marketing authorisation holder voluntarily, or pursuant to an obligation imposed by a competent authority. A PASS can be an integral part of drug approval and continuous development. A PASS needs multi-departmental input in a company and at regulatory approval level. It is the key to applying the right methodology for the correctly identified problem.

This course offers insight into GVP Module VIII on PASS. It delivers insight into (pharmaco-)epidemiological methodology for non-interventional studies, and the concept of multi-departmental collaboration for the development and conduct of a PASS. There will be a chance to practice with real life examples.

What participants from previous course say:
"PASS preparation was a good exercise!!!"

What You Will Learn
GVP Module VIII: Post-authorisation safety studies
Principles of Pharmacoepidemiology
Study types
Study sources
Methodology
Protocol development

Who Should Attend
This course is aimed at professionals working within:
Clinical Safety and Pharmacovigilance
Research and Development
Medical Affairs and Medical Marketing
Regulatory Affairs
Comparative Effectiveness, Health Technology Assessment, Evidence-based Medicine

Level: Intermediate

Learning Objectives
At the conclusion of this course, participants should be able to:
To understand the concept of PASS
To discuss the proper study methodology and setting in relation to the safety topic(s) of interest
To deal with the latest EMA/CHMP/PRAC and EnCePP requirements for PASS studies

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Exhibitors

Gro Laier, Jan Petracek

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