Clinical trial sponsors who have to tell EudraVigilance about an unauthorised, "development" medicinal product get a dedicated two-session course from EMA itself — –, online, walking through the XEVPRM submission format inside the XEVMPDweb interface.
Dates and format
- Date: 3–4 November 2026, 09:00–13:30 CET (Amsterdam time) each day
- Format: online, live virtual instruction
- Organizer: European Medicines Agency (EMA)
- Registration: open enrollment, booked through DIA's EMA course-listing platform (credit-card payment for EMEA registrations)
What it covers
This session targets sponsors specifically — the XEVMPD submission obligations that fall on a clinical trial sponsor under Article 81(3), distinct from the broader marketing-authorisation-holder version of the same training. It walks through the guidance and data elements needed to submit information on unauthorised "development" medicinal products in the XEVPRM format, with hands-on exercises inside the XEVMPDweb data-entry interface. EMA's own training overview describes a knowledge check that, once passed, clears the way for EudraVigilance registration for electronic submissions.
Who should attend
Regulatory operations and pharmacovigilance staff at trial sponsors who own EudraVigilance submissions for development products, and staff at contracted third-party service providers who file on a sponsor's behalf. For the broader EudraVigilance signal-detection side of the same system, see EMA's EudraVigilance Signal Detection Forum; for hands-on audit and inspection readiness, DIA's Advanced PV Audits and Inspections course covers adjacent ground.
Frequently asked questions
When does EMA's XEVMPD training course for sponsors run?
Online, 3-4 November 2026, 09:00-13:30 Amsterdam time (CET) each day.
Who should attend?
Clinical trial sponsors (commercial and non-commercial) who need to submit information on unauthorised "development" medicinal products to EudraVigilance via the XEVMPD. A staff member of a contracted third-party service provider can attend in a sponsor's place.
Is registration open to any company, or restricted?
Open enrollment — sponsors register via DIA's EMA course-listing platform, unlike EMA's by-nomination industry stakeholder platform meetings. It is a paid course, not a free public briefing.
What does the course cover?
The data elements and submission format (XEVPRM) for development medicinal products, with hands-on exercises in the XEVMPDweb user interface, per EMA's own course description.
Is there a fee to attend?
EMA's training is fee-based and booked through DIA's course listing; this listing could not confirm the exact fee for this specific sponsor session as of verification. Confirm current pricing on the registration page before booking.
Sources & further reading
- EMA. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - November 2026. ema.europa.eu
- DIA. eXtended EudraVigilance Medicinal Product Dictionary Training Course — registration. diaglobal.org
Event details are published by the organizer and can change. This listing was corroborated via web search rather than a direct fetch of the organizer's page (network egress was blocked this session); confirm dates, time and current fees with EMA/DIA before registering. Last verified 13 October 2026.
