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).
José Ortiz will be participating as a trainer in the next XEVMPD training for SPONSORS on 4-5 May 2023.
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.
Please read more and register in the link below:
PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.
