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)…

Continue ReadingEVWEB and XEVMPD Basel (24th – 28th June)

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…

Continue ReadingEVWeb and XEVMPD Madrid (20th-24th May)

PVpharm Pharmacovigilance Training II edition review

  • Post published:July 9, 2019

On 9th and 10th  May 2019, PVpharm provided a pharmacovigilance training in Madrid. We had the honour to have as trainers:  Mariano Madruga: a well known professional with more than 30 years dedicated experience in pharmacovigilance, being an official of the Ministry of health/AEMPS and developing the pharmacovigilance Network in Spain.Calin Lungu: Dr. Lungu has worked more than 20 years in drug development, clinical research, pharmacovigilance and quality assurance. He has done more than 140 PV audits and trained more than 250 Eudravigilance and XEVMPD courses at the EMAAlbert García Rierola: The EU-Qualified person responsible for pharmacovigilance (QPPV) at Ferrer…

Continue ReadingPVpharm Pharmacovigilance Training II edition review
EVWEB Prague 15th-17th May
EVWeb training in Prague

EVWEB Prague 15th-17th May

  • Post published:April 25, 2019

José Alberto Ayala Ortiz, the CEO of PVpharm, will be participating as an instructor in the EVWEB training organized by the DIA association in Prague from the 15th till the 17th May. This training, "The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format", will involve the functionalities of the new EVWEB application, practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B (R3) format. For more information and registration, please visit DIA and EMA websites to find the full training programme. PVpharm is also organizing in-house trainings in pharmacovigilance for…

Continue ReadingEVWEB Prague 15th-17th May

PV Training II Edition is here!

  • Post published:March 20, 2019

After the success of the first edition of the I Pharmacovigilance Training, PVpharm is organizing its Pharmacovigilance Training II Edition on the 9th and 10th of May 2019 in Madrid.The course will cover different trending topics in PV; focusing on Audits, Inspections, the QPPV role and Eudravigilance and Signal Detection. We will also cover the new GDPR from the perspective of Pharmacovigilance!Our speakers include: Mariano Madurga (Ex-Head of Co-Ordination Unit of the Spanish Pharmacovigilance System. Spanish Medicines and Healthcare Products Agency)Calin Lungu (Lead EV and XEVMPD trainer, expert pharmacovigilance auditor, PV QA consultant, CEO of DDCS)Maite Vazquez (Partner Life Sciences DA…

Continue ReadingPV Training II Edition is here!

We are in the press!

  • Post published:March 14, 2019

Last Sunday, 10th March 2019, the news diary “La Razón” published an article about PVpharm; where our CEO, José Alberto Ayala Ortiz, introduces our company, explains what pharmacovigilance is and how does PVpharm deal with different regulations. You can follow us on Linkedin and learn more about us clicking here.

Continue ReadingWe are in the press!