Workshop on the implementation of ISO standard for individual case safety reports (ICSRs)

• Date:
  Friday, 4 March 2016, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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 [e-mail] with 'EU ISO ICSR workshop: March 2016' in the subject line, by 1 February 2016. Attendees will be confirmed before 15 February 2016.

Documents

Presentation - Session 1 – Documentation, resources and implementation milestones

Presentation - Session 2 – ISO ICSR Implementation technical aspects - Part 1

Presentation - Session 3 – ISO ICSR Implementation technical aspects - Part 2

Presentation - Session 4 – Testing with EMA new process

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)...

Reference Number: EMA/847935/2015