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

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.

Continue ReadingDevelopment substance data request from EMA – Action required by 01-09-2023
PVpharm starts a new collaboration with the International AIDS Vaccine Initiative (IAVI)

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

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).

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).
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…

Continue ReadingCTIS Reminder for Sponsors: Register your organization and Administrator!
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