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Post-Authorisation Safety Studies (PASS)

Jun 18 2014 8:00AM - Jun 19 2014 1:00PM | NH Musica van Leijenberghlaan 221 1082 GG Amsterdam Netherlands

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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
  • Methodology
  • 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

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.

Hotel & Travel 

This training course will take place in:

Hotel NH Musica
van Leijenberghlaan 221
1082 GG Amsterdam
the Netherlands
Tel: +31 20 79 56 088
E-mail: nhmusica@nh-hotels.com

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.

Contact Information 

DIA Europe
Kuechengasse 16
4051 BASEL

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: diaeurope@diaeurope.org


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Registration Fees 


Charitable Nonprofit/Academia Member
Member Government
Member Standard


Charitable Nonprofit/Academia Nonmember
NonMember Government
NonMember Standard
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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