Development substance data request from EMA – Action required by 01-09-2023

Post published:July 14, 2023

As an owner of development substance data in the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD), the EMA is requesting an action by 1st of September 2023. For the unmapped substance data, the EMA is asking organizations to raise a request for the creation of new approved substance data. This activity requires time, expertise and experience with the xEVMPD. In PVpharm we are experts in xEVMPD, as well as xEVMPD trainers. We can help you to perform this activity on time. Please contact us.

IV PV TRAINING: unique pharmacovigilance training experience

Post published:July 11, 2023

PVpharm led the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training. This 3rd edition was hosted on May, 2022.

III PV TRAINING: Leading experts make success possible

Post published:June 22, 2022

PVpharm led the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training. This 3rd edition was hosted on May, 2022.

Time to meet in person again: PV TRAINING III EDITION

Post published:March 24, 2022

PVpharm organizes its successful Pharmacovigilance Training. This 3rd edition will be hosted in Madrid on May 30 and 31, 2022, with the option of attending online.

PVpharm on the EMA course: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU

Post published:September 28, 2021

PVpharm is pleased to inform that José Ortíz, will be a trainer in the course "Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Practical training course with the EudraVigilance system" carried out by the European Medicines Agency (EMA).

PHARMACOVIGILANCE TRAINING III Edition – Madrid 21-22 May 2020, Save the date! – UPDATE: postponed

Post published:March 20, 2020

PVpharm is organizing the III Edition of the PHARMACOVIGILANCE TRAINING, this year it will be held in Madrid. The training was originally scheduled for the 21-22 of May 2020, but it has been posponed due to COVID-19. We will publish the new dates very soon. The previous editions in 2018 and 2019 were really successful, so we continue with a similar format, giving the participants now the chance to send questions to the speakers in advance. This year again, we have the honour to count with very relevant and experienced Speakers that will share their PV knowledge with the participants: Doris…

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System Madrid (25th-27th March)

Post published:January 31, 2020

PVpharm is pleased to inform that our CEO, Jose Alberto Ayala Ortiz, will be participating as an instructor in a hands-on training course on the ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU. The course will take place in Madrid from 25th to 27th of March and will provide the extensive information regarding EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS. This hands-on training course covers: In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR…

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

Post published: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…

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

Post published: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)…

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

Post published: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…