Post-Authorisation Safety Studies (PASS)
About This Event
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.
URLs
Booking: http://atnd.it/28280-1
Price:
Member Charitable Nonprofit/Academia/Government:EUR 605
Member Standard:EUR 1210
Charitable Nonprofit/Academia/Government:EUR 765
Standard:EUR 1370
Speakers: Gro Laier, Jan Petracek
Time: On Monday September 21, 2015 at 10:00 am and ends Tuesday September 22, 2015 at 3:00 pm