Pharmacovigilance services for the Pharmaceutical Industry.

Audit on Signal Detection at Perrigo

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.

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Pharmacovigilance training 1st edition review.

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 EMA and other locations). 

Our trainers focused on the latest regulatory changes involving Eudravigilance, Signal Detection and EVDAS, resolving doubts and showing real life examples on how the legislation should be applied in different situations.

The training was held at the heart of Madrid, the emblematic Hotel Emperador, where we could even enjoy the sunset on the terrace of the building after the 1st day of the course. This, and the rest of the breaks during the session, allowed the participants to network in a multicultural environment, as the participants came from many different locations.  

After the course, an anonymous poll was presented to each participant. We would like to highlight two questions from the anonymous reviews:

– The results from question 1 showed more than half of the participants rated the course as Excellent, and the rest considered the course was very good (Figure 1). 

 Figure 1. Question 1 results from the anonymous poll. 

– Question 2 results are the following:

How likely is it that you would recommend this course to a friend or colleague (from 0 “not likely at all” to 10 “Extremely likely”)Being 0 “not likely at all” and 10 “extremely likely”, participants assessed the possibility of recommending this course to a friend or colleague as 9,4 (mean of the total answers).

We are very pleased with the results from the course and we are already looking forward to prepare a second edition of this training. Thanks to all the participants!

Hope to see you all there to share more Pharmacovigilance knowledge! 

PVpharm Team.

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Signal detection training at CHEMO

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.

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