Event Date/Time: May 08, 2012
End Date/Time: May 08, 2012
The finalisation of the five new international Identification of Medicinal Product (IDMP) standards and the development of the ICH Implementation Guide (topic M5) will further progress in 2012. The final draft international standards (FDIS) were released for ballot by 16 of April 2012, with the final standards expected by end of 2012. The key features of the new standards, the results of the ICH alpha testing and the key principles outlined in the ICH IDMP Implementation Guide will be presented and explained. In ad dition,the technical and process related aspects will be addressed to allow pharmaceutical companies to prepare for a coordinated, well organised approach in putting the new standards into operation, taking into account the timelines and requirements as set out in the new pharmacovigilance legislation in the EU. The latest developments in the context of the implementation of Article 57 will also be addressed.
A detailed agenda will be available some weeks before this Information Day.
Representatives of IT departments of medicines regulatory authorities, pharmaceutical companies,
and service providers
EU Qualified Persons Responsible for Pharmacovigilance (EU QPPVs)
Pharmacovigilance staff of pharmaceutical companies and medicines regulatory authorities
Pharmacovigilance software vendors
Sponsors of Clinical Trials