Overview

Sponsors of clinical trials are responsible for providing information on Investigational Medicinal Products (IMPs) in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) in accordance with the CT-3 detailed guideline on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (“CT-3”, chapter 7.9, paragraph 104).

The EMA has prepared this live virtual training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on development medicinal products (DMPs) by commercial and non-commercial sponsors of clinical trials in the European Economic Area (EEA).

The training focuses on explaining the guidance and mandatory data elements necessary for the electronic submission of information on development medicinal products (DMPs), applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes practical exercises in EVWEB for the electronic submission and maintenance of development medicinal product information.

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. This notification is requested from at least one user from the sponsor organisation during the registration with EudraVigilance for the electronic submission of information on DMPs. The aim is to ensure the quality of data submitted to the XEVMPD.

Who should attend?

The XEVMPD training programme is intended for 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.
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, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (“CT-3”, chapter 7.9, paragraph 104).

COURSE PREREQUISITIES
Participants are expected to have:
• Requested access to the training environment as per instructions provided upon registration
• Completed technical setup and have ActiveX and IE Tab extension installed on their computers before the start of the training course, as per instructions provided upon registration
• Basic background knowledge of the EU legislation and be familiar with guidance documents published by the EMA, specifically Chapter 3.II: XEVPRM User Guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004

Learning objectives

At the conclusion of this training course participants will be able to:

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)
Use the eXtended EudraVigilance Product Report Message (XEVPRM) format used for electronic submission of information on 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 DMPs
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 submission of clinical trial information in the Clinical Trials Information System (CTIS)

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eXtended EudraVigilance Medicinal Product Dictionary for Sponsors virtual training course

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.