DIA Pharmacovigilance QMS virtual course (21-24 September)

September 14, 2021

José Ortiz will be participating as a trainer together with Wendy Huisman in the Pharmacovigilance Quality Management System course organized by DIA. The training will be delivered online from 1:30 PM to 6:00 PM (CEST). The course will employ a mix of informative sessions, real case studies, and hands-on interactive exercises where attendees will be able to apply what they have learned. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance. Course Highlights Quality and the Quality SystemQMS OverviewPV SystemSystem, Processes, Quality DocumentsPSMF and PV…

Online XEVMPD training 13-15 September 2021

September 3, 2021

José Ortiz will be participating as a trainer in the next XEVMPD training on 13-15 September 2021. The training will be delivered online in the morning time (9:00-13:00 CEST). 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…

Risk Management Plan (EU-RMP) Creation Virtual Live Training Course

August 24, 2021

Jan Kolouch will be participating as a trainer in the next Risk Management Plan training on 14-16 September 2021 organized by DIA. The training will be delivered online in the morning time (09:00-13:00 CEST). This virtual live course is aimed at the practical aspects of the EU Risk Management Plan (EU-RMP) creation process. We will demonstrate the various uses of the EU-RMP within the lifecycle of medicinal products, medical writing process and RMP management process. It will provide a detailed understanding of the GVP Module V (Rev. 2) with all potential implications for the marketing authorisation holders. The participants will…

Online XEVMPD training 14-16 June 2021

May 19, 2021

José Ortiz will be participating as a trainer in the next XEVMPD training on 14-16 June 2021. The training will be delivered online in the afternoon time (14:00-18:00 CEST). 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…

José Ortiz to participate in the AEFI Symposium 2021

May 7, 2021

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/

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.…

Online XEVMPD training 19-21 April 2021

April 7, 2021

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…

Jan Kolouch from PVpharm to speak at conforum – pharmacovigilance seminar January 21, 2021

January 18, 2021

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…

QMS virtual course – 26-29 January 09.00-13.30 CEST

December 9, 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…

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…