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 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…
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…
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…
https://youtu.be/M_0jKEjl6v4 PVpharm was holding the 2020 Offsite meeting at hotel Envia Golf in Almería. Watch the video here!
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…
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.
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…
PVpharm is organizing the III Edition of the PHARMACOVIGILANCE TRAINING, this year it will be held in Madrid. The training was originally scheduled for the 21-22 of May 2020, but it has been posponed due to COVID-19. We will publish the new dates very soon. The previous editions in 2018 and 2019 were really successful, so we continue with a similar format, giving the participants now the chance to send questions to the speakers in advance. This year again, we have the honour to count with very relevant and experienced Speakers that will share their PV knowledge with the participants: Doris…
Let's help everyone stop COVID-19! At PVpharm we adopted business continuity actions in order to save the health of the people working in PVpharm and provide continuation of our PV services to our dear customers. PVpharm is following the recommendations of the Spanish Health Authority, that is recommending to restrict movement of people due to the COVID-19 outbreak. PVpharm decided that all employees should work from home starting on Monday 16th March 2020. Only under special circumstances it would be allowed to come to the physical offices. No disruption in our services is expected from this situation. Our team will…