We are happy to announce that José Ortiz, PVpharm's CEO will be participating in one session of the 2021 Pharmacovigilance symposium organized by AEFI. During the session, José will be talking about outsourcing of pharmacovigilance activities. Please take a look to the program at this link: https://www.aefi2021.com/
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.…
José Ortiz will be participating as a trainer together with Dr. Calin Lungu in the next XEVMPD training on 19-21 April 2021. 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 and register in…
We are happy to inform that Jan Kolouch, Head of Pharmacovigilance and Clinical Safety at PVpharm, will be speaking at the pharmacovigilance seminar on January 21st , 2021. This seminar will be in Czech and organized virtually. Jan will be speaking together with other speakers, including representatives from national agency (SUKL). You can see the full information of this event at the link below: https://www.konferenceseminare.cz/farmakovigilance-aktualne-a-prehledne This online seminar will be conducted in the local language focusing on periodic safety reports and their evaluation, pharmacovigilance inspections and findings, pharmacovigilance reporting, signal management, EudraVigilance and Brexit. PVpharm also provides in-house trainings for pharmaceutical…
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…
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…
https://www.youtube.com/watch?v=fdfovftF_Zg&feature=youtu.be Today we share this interview in Spanish, where José Alberto Ayala Ortiz is invited in an interview on "Visitadores Médicos Digitales" by Miguel Ángel Martínez Barreira. Please watch the video here. PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.
We are delighted to announce that José Alberto Ayala Ortiz, PVpharm's CEO, will be participating in the European Pharmacovigilance Congress 2020 organized by the Pharma Education Center. You can find the link to the Congress here: https://www.pharmaeducationcenter.it/wp-content/uploads/2020/11/EUPV_Final_2020-1.pdf José will be participating in two round tables on the 27th of November:-Eudravigilance EVDAS updates-Local VS Global PV regulations Please see some screenshots of the sessions: PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.
José Ortiz will be participating as a trainer together with Raj K. Bains and Calin Lungu in the next XEVMPD training on 23-25 November 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…
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…