Pharmacovigilance services for the Pharmaceutical Industry.

EVWEB and XEVMPD Training in Amsterdam (16th-20th September)

From the 16th to the 20th September, José Alberto Ayala Ortiz will be participating as an intructor on the EVWEB and XEVMPD training courses provided by the European Medicines Agency (EMA) in Amsterdam.

From the 16th to the 18th September, a hands-on Training Course using the EudraVigilance System will be provided.

This training course covers:
-Explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B (R3).
-The use of EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3).
-Reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products”
-How to comply with the EudraVigilance business rules and the EudraVigilance Gateway, including WebTrader.
-Instruction on using the ICSR download functionality for MAHs to access ICSRs.

On the other hand, a face-to-face training course on eXtended EudraVigilance Medicinal Product Dictionary is provided on the days 19th and 20th September.

This training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB).

For more information and registration, please check EMA or DIA website.

PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.


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PVpharm Pharmacovigilance Training II edition review

On 9th and 10th  May 2019, PVpharm provided a pharmacovigilance training in Madrid.

We had the honour to have as trainers:

  •  Mariano Madruga: a well known professional with more than 30 years 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. He has done more than 140 PV audits and trained more than 250 Eudravigilance and XEVMPD courses at the EMA
  • Albert García Rierola: The EU-Qualified person responsible for pharmacovigilance (QPPV) at Ferrer International. He has experience in different areas such as regulatory affairs and price and reimbursement,
  • Maite Vázquez: economist and lawyer, with training in Biotechnology and Pharma Law. She is the secretary of the Board of the Spanish Biotechnology Association (ASEBIO) and legal advisor in the Pharma and Health group of the Bar Association of Madrid (ICAM) and she has been advising companies in pharma and bio industry in regulatory, contracts, corporate and compliance matters.
  • José Alberto Ayala Ortiz: Pharmacist with specialty in IT who has been working more than 16 years in Pharmacovigilance and Drug Safety in multiple places including the Danish Agency and also as a trainer for EVWEB and XEVMPD trainings at the EMA and other locations.

During this course, we focused on different aspects and areas such as how a PV department is organized, the role of the QPPV and how this function is audited, personal data protection issues in PV, latest updates in the use of EVDAS for signal detection, ICSRs, PSURs, etc.

The training was held in Madrid, at the emblematic Hotel Emperador. The course was held in English, and there were participants coming from several locations across Europe. We could enjoy a fantastic atmosphere during the training and we would like to thank the participants for their valuable and professional contribution to the training.

Just like in the 1st edition, after the training, an anonymous questionnaire was administered to the participants in order to assess their satisfaction and to improve our performance on the coming editions. We would like to highlight 2 questions form the reviews:

Question 1. This course was…

As we can see, most of the participants, around 88%, describe the course as “excellent” or “very good”.

Question 2: How likely would you recommend this course to a friend or colleague (from 0 “not likely at all” to 10 “extremely likely”.

Participants assess the possibility of recommending this course to a friend or colleague as 9 (mean of the total answers).

The results were quite positive and we are very delighted and thankful to everyone for their inputs. We are looking forward to the 3rd edition!

PVpharm team.

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PV Training II Edition is here!

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.

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We are in the press!

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.

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PVpharm to participate at EUPV Congress in Milano

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: 

https://www.eupharmacovigilance.com/

REMEMBER!
PVpharm is always keeping up with the last changes in pharmacovigilance and organize trainings adapted to every necessity. Take a look to our training page for more information.

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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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