In November 2012, step 4 of ICH E2B (R3) package has been signed off including the awaited implementation guide accompanied by several technical appendices. This step opens the way for the worldwide implementation of the new ICSR replacing progressively the current E2B (R2). This information day will present and explain the main and latest changes to E2B and its appendices as well as what, how and when they will be required in the EU and the US.
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) Implementation Guide and the ISO/HL7 messaging standards
- Update medicines regulatory authorities in the EU, pharmaceutical companies and IT vendors on the international standardisation work and the impact in the context of the new pharmacovigilance legislation
- 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 MedDRA for reporting of medication errors, misuse, abuse and occupational exposure
- Key differences between the ISO ICSR International Standard and the current ICH E2B(R2)guideline/M2 messaging format
- Initiation of pilot testing in collaboration between US FDA and EU
ICH E2B(R3) Implementation Guide and consolidated comments from an EU and US perspective
- Health Level Seven (HL7) standard for electronic information exchange
- Use of MedDRA in the context of the new ICSR reporting – impact on coding and data retrieval
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
DIA was able to negotiate a special rate for participants to the EudraVigilance training course. Room rate is GBP 145.00 (2012 rate) per room incl. breakfast excl. VAT
Please click here to book your accommodation at the designated hotel. In order to profit from our special rate we would kindly ask you to use our corporate number (481223696).
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).