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 You Will Learn
- GVP Module VIII: Post-authorisation safety studies
- Principles of Pharmacoepidemiology
- Study types
- Study sources
- Protocol development
Who Should Attend
This course is aimed at professional working within:
Clinical Safety and Pharmacovigilance
Research and Development
Medical Affairs and Medical MarketingRegulatory Affairs
Comparative Effectiveness, Health Technology Assessment, Evidence-based Medicine
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.
Hotel & Travel
This training course will take place in:
Hotel NH Musica
van Leijenberghlaan 221
1082 GG Amsterdam
Tel: +31 20 79 56 088
DIA has blocked a limited number of rooms at the rate of EUR 128.33 per room/night, including VAT and tax, excluding breakfast. To make the reservation, please click here.
Important: The room rate is available until 22 April 2014 or until the group block is sold-out, whichever comes first. Please make your reservations as soon as possible.
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52