The New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2 Information Day (3rd)

Date(s) And Time(s):
Nov 16 2011 8:00AM - Nov 16 2011 5:00PM

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

Overview:

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:
11525

Contact Information:
DIA Europe
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG
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