eXtended EudraVigilance Medicinal Product Dictionary training course
The submission of data on medicines by marketing-authorisation holders is a legal requirement from Article 57(2) of Regulation (EC) No. 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012.
The EMA has prepared this eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training 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) and European Economic Area (EEA) countries outside the EU.
The training focuses on explaining the guidance and 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 (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.
Participants who successfully pass the knowledge evaluation following the training course will receive a notification of successful completion of this training course from the European Medicines Agency that will allow them to register with EudraVigilance for the electronic submission of information on medicinal products. At least one user from each marketing-authorisation holder organisation should receive training. The aim is to ensure the quality of data submitted to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
The course also includes instructions for sponsors of clinical trials on how to provide information on Investigational Medicinal Products (IMPs) in the medicinal product dictionary before completing the clinical trials application form.
Please visit the dedicated XEVMPD training and support webpage on the EMA website for more information.
Who should attend?
The programme content is also geared towards sponsors of clinical trials responsible for providing information on IMPs in accordance with the CT-3 detailed guideline on the collection, verifi cation and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (“CT-3”, chapter 7.9, paragraph 104).
At the conclusion of this training course participants should be able to:
- Understand the legal requirements for marketing authorisation holders to comply with the provisions set out in Article 57(2) of Regulation (EC) 726/2004, as amended by Regulation (EU) 1235/2010 and Regulation (EU) 1027/2012
- Understand the requirements for sponsors of clinical trials as outlined in the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use’ (‘CT-3’) (OJ 2011/C 172/01)
- Be familiar with the eXtended EudraVigilance Product Report Message (XEVPRM) format used for the electronic submission of information on authorised medicinal products as well as investigational medicinal products
- Understand the controlled vocabularies and terminologies to be used during the submission process
- Use the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products
- Explain the data structure of the eXtended EudraVigilance Product Dictionary (XEVMPD) for data entry and data retrieval
- Understand the importance of the XEVMPD to support the pharmacovigilance activities in the EU