Date(s) And Time(s):
Nov 16 2011 8:00AM - Nov 16 2011 5:00PM
European Medicines Agency
7 Westferry Circus
ICH E2B guideline is changing in the frame of ISO and HL7 collaboration and its approval is expected by mid 2011. The new guidelines ICH E2B (R3) together with the implementation guide are presented and explained to all the stakeholders involved in the electronic transmission of ICSRs and related matters.
The detailed programme will be available some weeks before the 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
ELISABETHENANLAGE 25, POSTFACH
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52