Risk Management Plan (EU-RMP) Creation Virtual Live Training Course

Post published:August 24, 2021

Jan Kolouch will be participating as a trainer in the next Risk Management Plan training on 14-16 September 2021 organized by DIA. The training will be delivered online in the morning time (09:00-13:00 CEST). This virtual live course is aimed at the practical aspects of the EU Risk Management Plan (EU-RMP) creation process. We will demonstrate the various uses of the EU-RMP within the lifecycle of medicinal products, medical writing process and RMP management process. It will provide a detailed understanding of the GVP Module V (Rev. 2) with all potential implications for the marketing authorisation holders. The participants will…

PVpharm to participate at EUPV Congress in Milano

Post published:November 8, 2018

PEC – Pharma Education Center S.r.l. warmly invites PV professionals from all over the world to the “European Pharmacovigilance Congress – 2nd Edition” which will be held on November 29-30, 2018in Milan, Italy. The core of the 2nd European Pharmacovigilance congress are the significant changes and challenges due to the EUDRAVIGILANCE implementation. PVpharm will be participating in the Congress. José Ortiz, our experienced trainer, will present a session with focus on Pharmacovigilance Quality System and impacts from the new Eudravigilance requirements. Others key speakers will give out updates about latest Inspection Trends in Pharmacovigilance, how is changing the Signal Detection process, which is the impact of new requirements on the PV process as well as…

Signal detection training at CHEMO

Post published:October 26, 2018

Signal detection training at CHEMO October 26, 2018 |PVpharm José Alberto Ayala Ortiz has been training the CHEMO Signal Detection team in Signal Detection. The training was held earlier this week at CHEMO offices in Madrid. This was a one day training held in-house, the objective of the training/workshop was to focus on Chemo’s Eudravigilance profile, EVDAS and Signal Management and EVWeb ICSRs management from Eudravigilance. PVpharm is organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.