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 Lawyers)
Albert García Rierola (EU-QPPV / Head of Pharmacovigilance at Grupo Ferrer Internacional)
José Alberto Ayala Ortiz (PVpharm CEO, EU-QPPV, PV consultant)
For more information and to download our training brochure, please click here. You can also contact us for any further information, we will be glad to help you.
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.
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 deepen PV quality system and a lot more! In-depth analysis will be given on Patients Support Programmes (PSP) and engagement for the set up of appropriate risk management and risk minimization measures.
This 2 day Congress will offer in total 12 sessions of oral talks and keynotes presentations, including round-tables, networking lunch sittings, exhibit area to showcase new and emerging technologies.
WHY TO ATTEND
The European Pharmacovigilance Congress represents a great opportunity for professionals and stakeholders to meet targeted audience and fully interact with participants from the Pharma, Clinical and Regulatory community. This European event is a unique opportunity for exhibitors and sponsors to engage with global industry partners!
For more information take a look at the Congress website:
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.
Comments Off on Audit on Signal Detection at Perrigo
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!
Comments Off on Pharmacovigilance training 1st edition review.
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.
Comments Off on Signal detection training at CHEMO
October 26, 2018