Pharmacovigilance services for the Pharmaceutical Industry.

EVWEB and XEVMPD Training in Amsterdam (16th-20th September)

  • July 9, 2019

From the 16th to the 20th September, José Alberto Ayala Ortiz will be participating as an instructor on the EVWEB and XEVMPD training courses provided by the European Medicines Agency (EMA) in Amsterdam. From the 16th to the 18th September, a hands-on Training Course using the EudraVigilance System will be provided. This training course covers:-Explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B (R3).-The use of EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3).-Reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI "Management and reporting of…

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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)…

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EVWeb and XEVMPD Madrid (20th-24th May)

  • July 9, 2019

Our CEO, José Alberto Ayala Ortiz participated as an intructor in the EVWEB and XEVMPD training. The course was offered by The European Medicines Agency (EMA) and took place in Madrid from 20th to 24th May. The EVWEB hands-on training course "The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B (R3) format" was held from the 20th to the 22nd May. This training covered the functionalities of the new EudraVigilance web application (EVWEB) and it included practical examples for creating, sending and accessing individual case safety reports (ICSRs) in the new ISO/ICH…

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