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EudraVigilance Courses | Reference Documents | FAQs  

What is new in 2012? The European Medicines Agency (EMA) is implementing the electronic submission of information on medicines in the context of the new pharmacovigilance legislation. As required by this legislation, the Agency published the format for the electronic submission of information on medicinal products for human use on 1 July 2011. Marketing authorisation holders need to submit electronically to the Agency information on all medicinal products for human use authorised or registered in the European Union by 2 July 2012, using this format. Furthermore, marketing authorisation holders have to inform the Agency of any new or varied marketing authorisations granted in the EU as of 2 July 2012. In this context, the previous EudraVigilance Medicinal Product Dictionary training course was revised and a new training course on the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) was developed.

Until March 2012 a theoretical two-day course is offered in which participants will be provided with explanations of the Extended EudraVigilance Product Report Message (XEVPRM) data elements together with various examples as to how to populate the XEVPRM taking into account different types of medicinal products authorised or registered in the EU. Participants will also have the opportunity to learn how to describe the characteristics of substances based on various substance classes such as chemicals, polymers, proteins, nucleic acids and structurally diverse materials (e.g. vaccines, advanced therapies) using practical examples.

Starting April 2012 this course will be extended to a three day course including explanations on data entry through the newly developed web interface that the EMA offers.


How do I register with EudraVigilance at the European Medicines Agency? Please consult the EudraVigilance website for registration information or email: eudravigilanceregistration@ema.europe.eu.
What is the role of DIA Europe in the training? DIA Europe is acting as a conference organiser on behalf of the European Medicines Agency, taking care of all administrative matters including course registration, dissemination of competency assessment results and distribution of certificates.

Which courses are offered? 

Three-day Training course on Electronic Reporting of ICSRs in the EEA Two/Three-day Training course on the Extended EudraVigilance Medicinal Product Dictionary  One-day Introduction to Pharmacovigilance and Electronic Transmission of Individual Case Safety Reports (ICSR) for the use of Eudravigilance

Training Courses

How do I register for a training course? All scheduled courses in London and in Member States are published on the European Medicines Agency and DIA website. The courses in London take place at the Agency. The local courses take place at the address indicated on the programme. You can register online or by sending us the registration form via fax or email. If you register by fax/email, you will receive a confirmation together with an invoice within a week. The invoice has to be settled before the beginning of the course by credit card, bank transfer or cheque. If you register online, you will be asked for a credit card number in order to make an  immediate payment. You receive your confirmation and invoice approximately two weeks before the start of the course. You can profit from a multiple course discount if you register for more than one course at a time.

Training Courses

Do SMEs receive a special discount?

If your company is registered as an SME with the European Medicines Agency, you receive a special discount on the standard rate. Please include the confirmation of your status with your registration form. It is not possible to receive this discount when registering online. If you want to register your company as an SME with the European Medicines Agency, you will find more information on how to apply on the EMA website or you can contact Ms. Melanie Carr at

smeoffice@ema.europa.eu. Why should I register for this training course?

This course is the only EudraVigilance training programme officially recognised by the European Medicines Agency.


What is included in the registration fee? The registration fee includes training course material, use of IT equipment and refreshments.

How do I get to the European Medicines Agency
The European Medicines Agency is located at:

7 Westferry Circus,
Canary Wharf
London E14 4HB
Tel: (44-20) 74 18 84 00
Fax: (44-20) 74 18 84 16
http://www.ema.europa.eu/htms/aboutus/findus.htm

Please allow for 10-15 minutes to pass through the special security procedures required to enter the building.

The closest airport is London City Airport. Take a taxi to Westferry Circus or alternatively catch the Docklands Light Railway which goes to Canary Wharf or Westferry station. For further information on public transport, you can use the following journey planner.


What happens if I do not pass the Competency Assessment? The assessment consists of two sections. You have three attempts to pass each section of the assessment.

 
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