The EMA has prepared this eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU).
The training focuses on explaining the guidance, specifically the mandatory data elements necessary for the electronic submission of information on medicinal products applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool also known as EVWEB.
The course also includes instructions for sponsors of clinical trials as how to provide information on the IMPs in the EudraVigilance Medicinal Product Dictionary (‘EVMPD’) before completing the clinical trials application form.
Who Should Attend
The XEVMPD training programme is targeting personnel of marketing authorisation holders, consultants and other organisations, who are responsible for the electronic submission and maintenance of information on medicinal products authorised in the EU. It is also targeting sponsors of clinical trials responsible for providing information on IMPs in accordance with the CT-3 detailed guideline.
At the end of this course, participants should be able to:
Understand the concepts related to the electronic submission of information on medicines authorised in the EU
Describe the format and the data elements of the XEVPRM for authorised medicinal products
Discuss practical examples of different types of medicinal products
Get hands-on experience in working with the XEVMPD
Describe the format and the data elements of the XEVPRM for IMPs
- General Terms and Definitions
- Registration in EudraVigilance and Qualified Person Responsible for Pharmacovigilance (QPPV) registration
(incl. sponsor registration)
- XEVPRM XSD Schema
- XEVPRM data elements and examples including hands-on exercises
- Operation Types
- Data Quality
- Data Ownership
- XEVMPD technical validation rules
- Use of Controlled Vocabularies
DIA Europe, Middle East and Africa
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
For technical questions or registration to EudraVigilance:
EudraVigilance helpdesk for Sponsors
Eudravigilance registration team
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 EudraVigilance courses 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 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.
A special discount for SMEs on the standard rate is available. It is not possible to receive this discount when booking online. To proof your status as SME, a confirmation of the European Medicines Agency is necessary.
Multiple course discount available if booked together with the three-day EudraVigilance training course. Please contact email@example.com for more information.