Pharmacovigilance services for the Pharmaceutical Industry.
CTIS Reminder for Sponsors: Register your organization and Administrator!
CTIS Highlights

CTIS Reminder for Sponsors: Register your organization and Administrator!

  • December 19, 2021

The go-live of CTIS on 31 January 2022 is now less than two months away, and organisations throughout Europe and beyond are undergoing preparations for CTIS. Users are reminded that certain preparatory steps must be taken before it is possible to use CTIS. Sponsor organisations opting for the organisation-centric approach that are not yet registered in EMA’s Organisation Management System (OMS) must do so before using CTIS. Registration in OMS can be done by visiting the OMS webpage of the Substances, Products, Organisations and Referentials (SPOR) portal. An EMA account with a SPOR user role is required in order to…

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Vojtech Kvita from PVpharm to train EudraVigilance Data Analysis System (EVDAS): Practical approach on use for signal management in the EU

  • April 29, 2021

PVpharm is pleased to inform that Vojtech Kvita, will train the EudraVigilance Data Analysis System (EVDAS): Practical approach on use for signal management in the EU in the following dates: 24 Jun 2021 9:00 AM – 25 Jun 2021 1:00 PM 08 Jul 2021 9:00 AM – 09 Jul 2021 1:00 PM The online course will provide the extensive information regarding concepts, access policy, and use of the EudraVigilance Data Analysis System (EVDAS) for signal detection. Experienced trainers using EVDAS on a regular basis will share practical advice on how to download and interpret the data and use it for signal detection from a marketing authorisation holder perspective.…

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Jan Kolouch from PVpharm participates as co-trainer in the Eudravigilance EVWeb training 7-11 December 2020

  • December 4, 2020

PVpharm is pleased to inform that Jan Kolouch, will be participating as an co-trainer in the Eudravigilance EVWeb training, 7-11 December 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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Vojtech Kvita from PVpharm participates as co-trainer in the Eudravigilance EVWeb training 16-20 November 2020

  • November 9, 2020

PVpharm is pleased to inform that Vojtech Kvita, will be participating as an co-trainer in the Eudravigilance EVWeb training, 16-20 October 2020, 9:00 – 13:30 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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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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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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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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