Pharmacovigilance services for the Pharmaceutical Industry.
EVWEB and XEVMPD Basel (24th – 28th June)

EVWEB and XEVMPD Basel (24th – 28th June)

  • July 9, 2019

From the 24th to the 26th June, the European Medicines Agency (EMA) provided an EVWEB training course in Basel, Switzerland. PVpharm’s CEO, José Alberto Ayala Ortiz had the honor to participate as one of the instructors.

The training focused mainly on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products. Practical exercises were also included on the training for a better understanding and put in practice the acquired knowledge.

In the same location, from the 2th to the 28th June, EMA also provided a XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) face-to-face training course.

The EMA has prepared this 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 also includes instructions for sponsors of clinical trials on how to provide information on investigational Medicinal Products (IMPs) in the medicinal product dictionary before compelting the clinical trials application form.

For more information, check the EMA or DIA websites.

PVpharm is also organizing in-house trainings for pharmaceutical companies and CROs, please contact us for further information.