PVpharm to provide pharmacovigilance and CTIS support to the Center 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 Center of 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 Center 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!