|Title||Workshop on the implementation of ISO standard for individual case safety reports (ICSRs)|
|Date||04/03/2016 - 04/03/2016|
|Location||European Medicines Agency, London, UK|
|Summary||This workshop will provide a forum for industry and regulators to discuss the technical implications of the implementation of the International Organization for Standardization (ISO) standard for ICSRs across Europe. It will focus on the IT aspects of implementing the HL7 XML message and is specifically aimed at software vendors, service provides and pharmacovigilance system implementers. Interested organisations should nominate up to two people to attend. Spaces are limited and will be allocated on a first come, first served basis. Attendees should have relevant IT experience and are expected to be familiar with published International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and European Union (EU) technical documentation on ISO ICSR. Expressions of interest should be sent to email@example.com with 'EU ISO ICSR workshop: March 2016' in the subject line, by 1 February 2016. Attendees will be confirmed before 15 February 2016.|
|Name||Language||First published||Last updated|
|Presentation - Session 1 – Documentation, resources and implementation milestones||(English only)||2016-05-12|
|Presentation - Session 2 – ISO ICSR Implementation technical aspects - Part 1||(English only)||2016-05-12|
|Presentation - Session 3 – ISO ICSR Implementation technical aspects - Part 2||(English only)||2016-05-12|
|Presentation - Session 4 – Testing with EMA new process||(English only)||2016-05-12|
|Call for expressions of interest, from software vendors, service providers and pharmacovigilance system implementers, to attend a workshop on 4 March 2016 on the implementation of international ICSR standard (ICH E2B(R3))||(English only)||2016-01-13|
- Registration open until 01/02/2016.
- Places limited.
A video recording will be made available after the event.
To view use the 'Multimedia' tab.