PVpharm provides Qualified Person for Pharmacovigilance Services (EU QPPV)

Post published:February 28, 2019

PVpharm provides EU Qualified Person for Pharmacovigilance (EU QPPV) and Deputy EU QPPV with large knowledge and experience of the industry. Besides, PVpharm has contact persons for pharmacovigilance in several EU countries Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH's PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with the legal requirements.The EU QPPV has the following responsibilities regarding…

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…

Audit on Signal Detection at Perrigo

Post published:November 8, 2018

José Alberto Ayala Ortiz has been performing an audit dedicated exclusively on the Signal Detectionprocess at Perrigo. The audit was held at their main offices. The Signal Detection process was reviewed during the two days, and opportunities for improvement were proposed to the team. The main objective was to to contribute to improving risk management, control, and governance processes. 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. Please contact us to request more information about independent PV 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…

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.