Pharmacovigilance Audits

  • Post published:April 8, 2020

EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems. PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements. Our approach is risk and process based, our objective is to improve your pharmacovigilance system in order to achieve excellence in quality. We can perform face-to-face or remote audits. Our audit team consist of a group of experts in pharmacovigilance with several years of experience. Please contact us for more information.

Continue ReadingPharmacovigilance Audits

Pharmacovigilance training 1st edition review.

  • Post published:October 28, 2018

PVpharm organized a Pharmacovigilance training course on October 18th and 19th 2018. We had the honour to have as trainers: Mariano Madurga (a well known professional with more than 30 years of 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) and Jose Alberto Ayala Ortiz (pharmacist with specialty in IT who has been working more than 15 years in Pharmacovigilance and Drug safety in multiple places including the Danish Agency and also as trainer for EVWeb and XEVMPD trainings at the…

Continue ReadingPharmacovigilance training 1st edition review.

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.

Continue ReadingSignal detection training at CHEMO