In November 2012, step 4 of the ICH E2B (R3) package has been signed off based on the ISO ICSR standard including the awaited implementation guide (IG) accompanied by several technical appendices. This step opened the way for the worldwide implementation of the ISO ICSR standard replacing progressively the current E2B (R2) version. The first package (version 1.01) was made available on 12 April 2013 to the users in order to begin the testing phase and the implementation of data exchange between partners.
In the context of the EU implementation, a regional IG is being prepared addressing EU specific requirements in relation to the application of the ISO ICSR standard and the E2B(R3) package.
This Information Day will address and explain the key changes expected in relation to the application of the new ISO ICSR standard and how those will impact the EU adverse reaction reporting and electronic transmission activities.
What You Will Learn
Key differences between the ISO ICSR International Standard and the current ICH E2B (R2) guideline
The ICH safety message flow in the EU
Processing of safety and acknowledgement messages in case of technical or system failures
EU specific business rules and technical ICSR validation
ICSR specific concepts and their application in the EU (e.g. amendment report, causality assessment)
Coding of medicinal product information
Use of MedDRA in the context of the new ICSR reporting
Handling of attachments
EMA testing procedures with stakeholders
Who Should Attend
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
At the conclusion of this course, participants should be able to:
Recognise the new requirements as regards the ICH E2B (R3) and EU region specific implementation
Prepare for the implementation of the new ICSR standard and the adaptation of internal pharmacovigilance systems by all stakeholders involved (medicines regulatory authorities in the EU, IT vendors and pharmaceutical companies)
Understand the use of the new ICSR format in line with EU pharmacovigilance legislation
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52
Hotel & Travel
Attendees are kindly requested to make their own reservation. Recommended hotel close to the EMA:
Hilton London Docklands Riverside
265 Rotherhithe Street
London SE16 5HW
Tel: +44 20 7231 1001
Fax: +44 20 7231 0599
Special negotiated DIA rate for participants of the Information Day is GBP 139.00 per single room incl. breakfast and VAT (GBP 149.00 for double occupancy). Please book your room at least 30 days before arrival through this link.
For reservations after that date, please contact Beatriz Martinez at: beatriz01.martinez@Hilton.com.
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 Information Day takes place at the
European Medicines Agency (EMA)
7 Westferry Circus
London E14 4HB, UK
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.