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.


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

EVWEB and XEVMPD Basel (24th – 28th June)

From the 24th to the 26th June, the European Medicines Agency (EMA) provided an EVWEB training course in Basel, Switzerland. PVpharm’s CEO, José Alberto Ayala Ortiz had the honor to participate as one of the instructors.

The training focused mainly on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products. Practical exercises were also included on the training for a better understanding and put in practice the acquired knowledge.

In the same location, from the 2th to the 28th June, EMA also provided a XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) face-to-face training course.

The EMA has prepared this XEVMPD face-to-face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU.

The training also includes instructions for sponsors of clinical trials on how to provide information on investigational Medicinal Products (IMPs) in the medicinal product dictionary before compelting the clinical trials application form.

For more information, check the EMA or DIA websites.

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

Comments Off on EVWEB and XEVMPD Basel (24th – 28th June)

EVWeb and XEVMPD Madrid (20th-24th May)

Our CEO, José Alberto Ayala Ortiz participated as an intructor in the EVWEB and XEVMPD training. The course was offered by The European Medicines Agency (EMA) and took place in Madrid from 20th to 24th May.

The EVWEB hands-on training course “The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B (R3) format” was held from the 20th to the 22nd May. This training covered the functionalities of the new EudraVigilance web application (EVWEB) and it included practical examples for creating, sending and accessing individual case safety reports (ICSRs) in the new ISO/ICH E2B (R3). It also includes reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

On the other hand, The EMA aslo provided a XEVMPD “Extended EudraVigilance medicinal product dictionary” training. This training explained how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary.

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

Comments Off on EVWeb and XEVMPD Madrid (20th-24th May)

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.

Comments Off on PVpharm Pharmacovigilance Training II edition review
EVWEB Prague 15th-17th May
EVWeb training in Prague

EVWEB Prague 15th-17th May

José Alberto Ayala Ortiz, the CEO of PVpharm, will be participating as an instructor in the EVWEB training organized by the DIA association in Prague from the 15th till the 17th May.

This training, “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format”, will involve the functionalities of the new EVWEB application, practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B (R3) format.

For more information and registration, please visit DIA and EMA websites to find the full training programme.

PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

Comments Off on EVWEB Prague 15th-17th May

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.

Comments Off on PV Training II Edition is here!

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.

Comments Off on We are in the press!

EVWEB training in Amsterdam February 2019

The DIA is organizing an EVWEB training in which José Alberto Ayala Ortiz will participate as a trainer. The course will be taking place in Amsterdam, exactly at the BCN Amsterdam Arena from the 11th to the 13th February 2019.​SMLXL

 The hands-on training “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B (R·) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.
For more information and registration, please find the link to the EVWEB course and the complete courses program available on EMA website.PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

Comments Off on EVWEB training in Amsterdam February 2019

EVWEB training in Amsterdam December 2018

Amsterdam is the next place where the DIA is organizing an EVWeb training. The course will take place at the BCN Amsterdam Arena on December 10th to 12th. José Alberto Ayala Ortiz is participating as trainer for this course.

The EVWeb hands-on training  “The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam, The Netherlands” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.

Please find the link to the EVWeb course and the complete courses program available from the EMA website.

PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

Comments Off on EVWEB training in Amsterdam December 2018

EVWEB and XEVMPD training in London November 2018

The DIA is organizing an EVWeb and XEVMPD training course at EMA in London in June, respectively on the dates 12-14 and 15-16. José Alberto Ayala Ortiz is participating as trainer for these courses.

The EVWeb  hands-on training  “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI ‘Management and reporting of adverse reactions to medicinal products’ and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

The “eXtended EudraVigilance Medicinal Product Dictionary” 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). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

The course also includes instructions for sponsors of clinical trials on how to provide information on Investigational Medicinal Products (IMPs) in the medicinal product dictionary before completing the clinical trials application form.

Please find the link to the EVWeb course from the EMA website and the complete courses program available from DIA.

PVpharm is organizing in-house trainings for pharmaceutical companies and CROs, please contact us for further information.

Comments Off on EVWEB and XEVMPD training in London November 2018