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

Post published: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

Post published: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

Post published: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/

Online XEVMPD training 19-21 April 2021

Post published: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…

PVpharm provides support to the UCLouvain for COVID-19 phase II study project

Post published:March 30, 2021

We are happy to announce that PVpharm has been selected to provide safety support for a research project coordinated by the Catholic University of Louvain (UCLouvain) for a COVID-19 Phase II study. PVpharm will be supporting the clinical safety function with pharmacovigilance, report submission, safety report writing, Eudravigilance, CTIS and other PV and administrative related activities. PVpharm is providing support to Sponsors of clinical trials in the EU, please read more about our Pharmacovigilance services at https://pvpharm.com/pharmacovigilance/ Please contact us with any question https://pvpharm.com/contact/

PVpharm provides Local Contact Persons for Pharmacovigilance (LCPPVs) in the EU and the UK

Post published:January 22, 2021

PVpharm provides the Local Contact Person for Pharmacovigilance (LCPPV) in all EU countries and UK, besides we can also provide the EU Qualified Person for Pharmacovigilance (EU QPPV), UK QPPV and and Deputy persons with large knowledge and experience of the industry. Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH's PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with…

PVpharm selected as one of the top ten companies providing compliance services and transforming business

Post published:December 9, 2020

We are very glad to announce that PVpharm has been selected as one of the top ten companies providing compliance services and transforming business. The European edition of PharmaTech Outlook www.pharmatechoutlook.com has choosen us, a full article has been issued at the magazine website, it can be found here: https://compliance-europe.pharmatechoutlook.com/vendor/pvpharm-solving-the-riddle-of-pharmacovigilance-compliance--cid-1039-mid-107.html This recognition is coming in a very important moment for PVpharm. Thanks to the effort and good work of the team, PVpharm is growing and helping more companies. Also, PVpharm is initiating new strategic partnerships in order to support other companies in their Pharmacovigilance activities. Please read more about us…

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

Post published: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…

Entrevista a José Alberto Ayala Ortiz – Visitadores Médicos Digitales (Spanish Video)

Post published:November 26, 2020

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.

Jose Ortiz at the European Pharmacovigilance Congress 2020

Post published:November 19, 2020

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.