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…

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…

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…

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,…

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PVpharm’s offsite meeting 2020 (VIDEO)

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!

PVpharm’s team returning to the Office: Lessons learned from remote working under COVID-19 restrictions

Post published:June 19, 2020

After a period of working from home because of the COVID-19 situation, we are happy to announce the re-incorporation of the PVpharm's team members to the Almería office (HQ). The team will be back in the office by Monday 22nd June, after a period of full remote working initiated in April following the instructions of the Spanish Health Authority and the WHO recommendations. PVpharm office during remote working period of COVID-19 During this remote working period, we collected a number of lessons learned from remote working. We would like to share with the community some points: Communication is key. During…

Pharmacovigilance Audits

Post published:April 8, 2020

EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems. PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements. Our approach is risk and process based, our objective is to improve your pharmacovigilance system in order to achieve excellence in quality. We can perform face-to-face or remote audits. Our audit team consist of a group of experts in pharmacovigilance with several years of experience. Please contact us for more information.

Remote working instructions at PVpharm

Post published:April 7, 2020

COVID-19:REMOTE WORKING INSTRUCTIONS AT PVPHARM Due to the Coronavirus outbreak, PVpharm decided that all employees should work from home. Only under special circumstances it would be allowed to come to the physical offices. We would like to share with the community our rules, our tips, so everyone can benefit of this learning. Please, stay safe at home, try to avoid going out. Protect yourself and the rest of the society. It is a matter of civil responsibility and public health. Follow the recommendations of the Government and the WHO. Remote working instructions at PVpharm 1 - Stay focussed and committed…