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…

Jan Kolouch from PVpharm to speak at conforum – pharmacovigilance seminar January 21, 2021

Post published: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…

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.

PVpharm joining ISoP

Post published: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…

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…

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,…

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.