eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
Feb 20 2014 9:00AM - Feb 21 2014 5:00PM | Novotel Bucharest City Centre
Calea Victoriei 37B Sector 1
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
Hotel & Travel
Please contact Ms. Madalina Nedelciu from Business Travel to book a hotel room, flight or airport transfer. She will be pleased to assist you.
S.C. BUSINESS TRAVEL TURISM S.R.L.
Aleea Alexandru nr. 9A, 1st Distict,
Tel. +4 021 2315619
Fax. +4 021 2315622
Mob.+4 0729 835 337
It is not possible to register online for this course. Please fill in the registration form at the back of programme (view pdf).
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.
CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:
- Industry (Member/Non-member) = €200.00
- Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
- Tutorial cancellation: €50.00
If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.