Pharmacovigilance services for the Pharmaceutical Industry.

PVpharm contributes to a recent article about the Covid vaccine

  • September 23, 2021

"Pharmacovigilance in times of COVID-19 vaccines", is an article published in the Spanish journal Pharmatech and in which José Alberto Ayala Ortiz has been co-author. The world is facing the unprecedented challenge of the SARS-CoV-2 pandemic. The hope for a normal life relied on vaccines is compromised by messages that question them. For this reason, pharmacovigilance activities carried out by authorities, pharmaceutical laboratories, health professionals and patients are essential to assess information and not to rely on "fake news". In this regard, the article aims to highlight the role of pharmacovigilance. It is important that society, in addition to being…

Continue Reading

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…

Continue Reading

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/

Continue Reading

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

  • 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/

Continue Reading

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

  • 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…

Continue Reading

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…

Continue Reading

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

  • 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…

Continue Reading

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…

Continue Reading

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

  • 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.

Continue Reading

PVpharm joining ISoP

  • November 13, 2020

José Ortiz CEO of PVpharm has become member of the International Society of Pharmacovigilance (ISoP). The International Society of Pharmacovigilance (ISoP) is a professional, independent, non-profit society, open to anyone with an interest in the safe and effective use of medicinal products. The nature of the global pharmacovigilance landscape and societal context has been rapidly changing in recent years, and is still changing. ISoP considers it important that the aims of ISoP should reflect this wider scope. With this membership, PVpharm reinforces their commitment of working side by side with other PV experts and passionate professionals in order to improve…

Continue Reading