New Clinical Trials Information System (CTIS): key areas
The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR) and hence the go-live date for the CTIS will be on 31 January 2022.
Information about PVpharm
PVpharm’s offsite meeting 2021: a memorable event (VIDEO)
PVpharm has enjoyed several sessions where the team has enjoyed sailing on one of the most wonderful landscapes of Spain, the coast of Almeria.
PVpharm contributes to a recent article about the Covid vaccine
"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…
José Ortiz to participate in the AEFI Symposium 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/
PVpharm provides support to the UCLouvain for COVID-19 phase II study project
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 and Azierta agrees on a strategic alliance in Pharmacovigilance
PVpharm and Azierta agrees on a strategic alliance in the field of Pharmacovigilance. This alliance will make it possible to jointly design and commercialize advanced pharmacovigilance services both for the Spanish market and internationally. The alliance signed places both companies in a position of reference in the health consulting sector in the field of pharmacovigilance in Spain, currently providing its services to more than 2,000 clients that represent 80% of the pharmaceutical industry and a share close to 25 % of the market for pharmacovigilance services. PVpharm is supporting and helping organizations to improve their quality processes in Pharmacovigilance. Please…
PVpharm opens an office in Prague
We are happy to announce that PVpharm is opening an office in Prague (Czech Republic). For all our partners and collaborators we are welcoming you at our new location! PVpharm S.L. - Prague, Smichoff, Plzeňská 3350/18, 150 00 Praha 5-Smíchov, Chequia
PVpharm provides Local Contact Persons for Pharmacovigilance (LCPPVs) in the EU and the UK
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
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…
Entrevista a José Alberto Ayala Ortiz – Visitadores Médicos Digitales (Spanish Video)
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.