Clinical Trials Information System (CTIS) training 8-11 April 2024
The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR)
PVpharm initiates a collaboration with the Leiden University Medical Center (LUMC) in the Netherlands
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…
Training Online XEVMPD for SPONSORS 4-5 May 2023
This training will focus on explaining the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB).
Clinical Trials Information System (CTIS) training 2-5 May 2023
The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR)
PVpharm to provide pharmacovigilance and CTIS support to the Centre for Human Drug Research of the Netherlands (CHDR).
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…
CTIS for sponsors of clinical trials
Sponsors of clinical trials in the EU should be aware that the EMA’s Management Board, on 31 January 2022 established a harmonized approach to submission, assessment, and authorization of clinical trial applications.
New training Online XEVMPD for SPONSORS 17 Feb 2022
This training will focus on explaining the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB).
CTIS Highlights
CTIS Reminder for Sponsors: Register your organization and Administrator!
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…
New Clinical Trials Information System (CTIS): key areas
The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR) and hence the go-live date for the CTIS will be on 31 January 2022.