The New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2 Information Day

Date(s) And Time(s):
Apr 5 2011 8:00AM - Apr 5 2011 5:00

European Medicines Agency
7 Westferry Circus
Canary Wharf
E14 4HB
United Kingdom


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.

Target Audience:

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

Event Code:

Contact Information:
DIA Europe
TEL.: +41 61 225 51 51

FAX: +41 61 225 51 52