This one day course covers the pre-requisites for the three day training course on EudraVigilance – electronic reporting of ICSRs and is therefore recommended to newcomers in pharmacovigilance, in particular individuals dedicated to data entry and expedited reporting. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as the rules for expedited reporting in Europe for both Clinical Trials and Post-Marketing ICSRs.
Who Should Attend
This course is intended for newcomers in pharmacovigilance, who need to understand the basics of ICSRs
with main focus on EU requirements.
Participants who complete this course should be able to:
- Understand the ICSR reporting requirements
- Understand the basic vocabulary of pharmacovigilance
- Complete properly the components of an ICSR
- Compare ICSR components for post-authorisation and clinical trials
- Identify the resources available for further guidance
- Legal/regulatory basis
- Compliance with reporting requirements for ICSRs
- What is a pharmacovigilance case: scope, criteria for validity
- Classification of cases: Solicited/ unsolicited, serious/not serious, etc
- Overview of the ICH E2B requirements
- Main differences of data elements and adverse reaction reporting during clinical trials and in the postauthorisation phase
- Overview of the case flow in the EU
- Concepts and data elements of an ICSR (the main part of the training, focusing on content and quality
criteria of each important element)
- Case Follow-up: when and how it needs to be transmitted.
- Basic coding principles
- Data privacy requirements
Hotel & Travel
Attendees have to make their own reservation. Recommended hotel close to the EMA:
Hilton London Docklands Riverside
265 Rotherhithe Street,
London , SE16 5HW,
Telephone: +44 (0)20 7231 1001
Fax: +44 (0)20 7231 0599
Special negotiated rate for participants to the EudraVigilance training course for a limited number of rooms is GBP 139.00 per room (2014 rate) incl. breakfast and VAT. Please book your room at least 30 days before arrival through this online link:
The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. The landing stage is in walking distance to the EMA (2 min).
The training course takes place at the
European Medicines Agency (EMA)
7 Westferry Circus
London E14 4HB
Web site: www.ema.europa.eu
Please click here for a map on how to find the EMA.
Please click here for some useful transport information.
For the special security access procedure to enter the EMA building, please calculate a delay of up to 10-15 minutes. It is not possible to enter the building before 8.00 am.