Pharmacovigilance services for the Pharmaceutical Industry.

Online XEVMPD training 21-23 October 2020

  • October 15, 2020

José Ortiz will be participating as a trainer together with Raj K. Bains and Calin Lungu in the next XEVMPD training on 21-23 October 2020. The training will be delivered online. The 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. Please read more…

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Jan Kolouch from PVpharm participates as co-trainer in the Eudravigilance EVWeb training 12-16 October 2020

  • October 6, 2020

PVpharm is pleased to inform that Jan Kolouch, will be participating as an co-trainer in the Eudravigilance EVWeb training, 12-16 October 2020, 14:00 – 18:30 The online course will provide the extensive information regarding EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS. This training course covers: In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR Implementation GuideThe use of the EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to practice examples for…

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José Ortiz to participate as a speaker in the DIA QPPV forum 2020

  • September 30, 2020

José Ortiz, PVpharm CEO will participate as a speaker in the next QPPV forum organized by DIA. You can find more information in the link: https://www.diaglobal.org/en/conference-listing/meetings/2020/10/global-forum-for-qualified-persons-for-pharmacovigilance-qppv About the QPPV forum: In a changing and expanding world, this is still the only forum designed for QPPVs by QPPVs, now in its 14th year and still going strong. The QPPV Forum focuses on international QPs’ role and gives a high-level approach to the discussed topics and continues to identify key trends requiring QPPV awareness, input and oversight. This year’s objectives are built on past successes and have been shaped by valuable feedback…

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QMS virtual course in September – NEW DATES – 22-25 September 09.00-13.00 CEST

  • September 16, 2020

José Ortiz will be participating together with Brian Edwards in the faculty of the QMS training course organized by DIA. At the conclusion of this virtual live course, participants will be able to: • Describe how to design, develop, and manage a Quality System related to Pharmacovigilance System • Explain the components of the Pharmacovigilance Quality Manual • Describe the process for the development and maintenance of the Pharmacovigilance System Master File • Analyze how the Pharmacovigilance Quality System integrates with the Pharmacovigilance System • Discuss the development, maintenance, and quality oversight of Pharmacovigilance SOPs and Pharmacovigilance related documents, including…

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Faculty at Signal Management training by DIA

  • September 7, 2020

On 7-10 September 2020, José Ortiz, and Jan Kolouch from PVpharm provided the training faculty for the Signal Management training organized by DIA. This training provides knowledge over Signal Management to the participants, so they can apply the basic concepts and principles of signal detection in pharmacovigilance, from simple visualisation and tabulation methods to sophisticated data mining techniques. • Design the signal management process for institutions and companies of various sizes, portfolios and geographical presence, based on the possibilities and limitations of their data and resources • Understand key messages from the current European and US regulations on signal management,…

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PHARMACOVIGILANCE TRAINING III Edition – Madrid 21-22 May 2020, Save the date! – UPDATE: postponed

  • March 20, 2020

PVpharm is organizing the III Edition of the PHARMACOVIGILANCE TRAINING, this year it will be held in Madrid. The training was originally scheduled for the 21-22 of May 2020, but it has been posponed due to COVID-19. We will publish the new dates very soon. The previous editions in 2018 and 2019 were really successful, so we continue with a similar format, giving the participants now the chance to send questions to the speakers in advance. This year again, we have the honour to count with very relevant and experienced Speakers that will share their PV knowledge with the participants: Doris…

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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System Madrid (25th-27th March)

  • January 31, 2020

PVpharm is pleased to inform that our CEO, Jose Alberto Ayala Ortiz, will be participating as an instructor in a hands-on training course on the ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU. The course will take place in Madrid from 25th to 27th of March and will provide the extensive information regarding EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS. This hands-on training course covers: In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR…

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PVpharm participates in Nordic PV Day

  • October 26, 2019

On Thursday 24th October 2019 PVpharm participated at the Nordic Pharmacovigilance Day conference in Copenhagen, Denmark. Jose Alberto Ayala Ortiz, PVpharm CEO, was talking about Signal Detection using EVDAS. It was very nice to meet with former colleagues from the Danish Medicines Agency! Jose Alberto Ayala OrtizDoris Irene StenverVibeke Nielsen PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.

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EVWEB training in Amsterdam February 2019

  • February 4, 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)…

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EVWEB training in Amsterdam December 2018

  • November 24, 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…

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