Online XEVMPD training 23-25 November 2020

Post published:November 11, 2020

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…

Vojtech Kvita from PVpharm participates as co-trainer in the Eudravigilance EVWeb training 16-20 November 2020

Post published: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…

Online XEVMPD training 21-23 October 2020

Post published: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…

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

Post published: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…

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

Post published: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…

PVpharm joins FAEEM

Post published:September 18, 2020

PVpharm recently joined FAEEM (Almeria Foundation for Business Excellence). On 18th September 2020, José Alberto Ayala Ortiz and Elena Marín Cassinello participated in the governing board meeting that formally accepted PVpharm into FAEEM structure. FAEEM was created in 2007 by the Commission for Business Excellence of the Chamber of Commerce of Almería. The Foundation chaired from its foundation until December 2019 by the businesswoman Pilar Martínez-Cosentino and from that date by Enrique de los Ríos of the UNICA GROUP company. FAEEM was born with the mission of carrying out and promoting training activities focused on the development of entrepreneurs and…

Vojtech Kvita from PVpharm participates as speaker in the Clinical Trial Regulation Information Day for CEE Countries

Post published:September 17, 2020

Vojtech Kvita from PVpharm participates as speaker in the Clinical Trial Regulation Information Day for CEE Countries. The Clinical Trial Regulation Information Day provides a forum to prepare stakeholders from Central and Eastern European Countries for the implementation and launch of the new EU Clinical Trial Regulation (536/2014) which will replace the European Clinical Trials Directive (2001/20/EC). The Information Day will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes. It further aims to provide a platform for discussion about the compliance with the new Regulation and associated implementing acts in…

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

Post published: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…

Faculty at Signal Management training by DIA

Post published: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,…

Golf

PVpharm’s offsite meeting 2020

Post published:August 14, 2020

https://youtu.be/M_0jKEjl6v4 PVpharm was holding the 2020 Offsite meeting at hotel Envia Golf in Almería. Watch the video here!