Pharmacovigilance services provided by PVpharm

PVpharm extends the collaboration with the International AIDS Vaccine Initiative (IAVI)

  • Post published:March 18, 2024

We are so excited to announce the extension of our collaboration agreement with the International AIDS Vaccine Initiative (IAVI) to provide pharmacovigilance and regulatory consulting. IAVI is a nonprofit scientific research organization that develops vaccines and antibodies for HIV, tuberculosis, emerging infectious diseases (including COVID-19), and other neglected diseases, with a clear commitment to develop affordable and accesible solutions to these diseases. In the same way as our collaboration with the Leiden University Medical Center (LUMC) or with the Center for Human Drug Research (CHDR), PVpharm works to provide pharmacovigilance support in pre-approval phases of the development of innovative drugs. In this agreement, we also work…

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Development substance data request from EMA – Action required by 01-09-2023

  • Post published:July 14, 2023

As an owner of development substance data in the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD), the EMA is requesting an action by 1st of September 2023. For the unmapped substance data, the EMA is asking organizations to raise a request for the creation of new approved substance data. This activity requires time, expertise and experience with the xEVMPD. In PVpharm we are experts in xEVMPD, as well as xEVMPD trainers. We can help you to perform this activity on time. Please contact us.

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José Alberto Ayala Ortiz to participate in the AEFI Symposium 2023

  • Post published:June 1, 2023

We are happy to announce that José Alberto Ayala Ortiz, PVpharm's CEO will be participating in one session of the 2023 Pharmacovigilance symposium organized by AEFI. During the session, José will be talking about safety in food or food supplements. Please take a look to the program at this link: https://www.aefi2023.com/

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PVpharm starts a new collaboration with the International AIDS Vaccine Initiative (IAVI)

  • Post published:May 22, 2023

We are so excited to announce the new collaboration agreement signed by our company with the International AIDS Vaccine Initiative (IAVI) to provide pharmacovigilance and regulatory consulting. IAVI is a nonprofit scientific research organization that develops vaccines and antibodies for HIV, tuberculosis, emerging infectious diseases (including COVID-19), and other neglected diseases, with a clear commitment to develop affordable and accesible solutions to these diseases. In the same way as our collaboration with the Leiden University Medical Center (LUMC) or with the Center for Human Drug Research (CHDR), PVpharm works to provide pharmacovigilance support in pre-approval phases of the development of innovative drugs. In this agreement, we…

Continue ReadingPVpharm starts a new collaboration with the International AIDS Vaccine Initiative (IAVI)

PVpharm initiates a collaboration with the Leiden University Medical Center (LUMC) in the Netherlands

  • Post published:May 3, 2023

We are happy to announce that PVpharm have enter in a new agreement with Leiden University Medical Center (LUMC) to provide safety and regulatory consulting. LUMC was formed from a collaboration between the Academic Hospital Leiden and the Faculty of Medicine of Leiden University, and provides scientific and material support to first steps of the drug development in humans. As an innovator, the LUMC stands for improving healthcare and people's health. This is done on the basis of leading research and innovative education. The objective of the LUMC is to be one of the top 10 University Medical Centers in…

Continue ReadingPVpharm initiates a collaboration with the Leiden University Medical Center (LUMC) in the Netherlands

PVpharm to provide pharmacovigilance and CTIS support to the Centre for Human Drug Research of the Netherlands (CHDR).

  • Post published:January 24, 2023

We are happy to announce that PVpharm have enter in a new agreement with Centre for Human Drug Research (CHDR) to provide safety and regulatory consulting. This prestigious foundation, based in Leiden (NL) and with three decades of history, provide scientific and material support to first steps of the drug development in humans (phase I and II of Clinical trials). Our collaboration will focus on helping about EMA’s Clinical Trial Information System (CTIS) and pharmacovigilance tasks, essential in these steps of drug development. With different therapeutic areas of research, CHDR is a leading organization in this field, with projects as…

Continue ReadingPVpharm to provide pharmacovigilance and CTIS support to the Centre for Human Drug Research of the Netherlands (CHDR).

PVpharm at Farmaforum 2022 (Video)

  • Post published:October 18, 2022

PVpharm participated in the 2022 edition of FARMAFORUM. PVpharm presented their services. We created a VIDEO that you can see below. Pharmacovigilance and quality services GVP, GCP, GDP and GMP: As a Pharmacovigilance service provider, PVpharm offers a full range of PV services for the pharmaceutical industry, sponsors of clinical trials and other service provider companies. PVpharm also 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…

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Is the Local Medical Literature Search in Pharmacovigilance really an obligation?

  • Post published:January 19, 2022

It is well known that the medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products. However, we may have doubts about whether it is really mandatory or not. And indeed, yes, it is an obligation. The European Medicines Agency confirms this in the Good Pharmacovigilance Practices (GVP) Module VI: "The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties." "In addition, marketing authorisation holders should have procedures…

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CTIS Reminder for Sponsors: Register your organization and Administrator!
CTIS Highlights

CTIS Reminder for Sponsors: Register your organization and Administrator!

  • Post published:December 19, 2021

The go-live of CTIS on 31 January 2022 is now less than two months away, and organisations throughout Europe and beyond are undergoing preparations for CTIS. Users are reminded that certain preparatory steps must be taken before it is possible to use CTIS. Sponsor organisations opting for the organisation-centric approach that are not yet registered in EMA’s Organisation Management System (OMS) must do so before using CTIS. Registration in OMS can be done by visiting the OMS webpage of the Substances, Products, Organisations and Referentials (SPOR) portal. An EMA account with a SPOR user role is required in order to…

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