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.
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).
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…
PVpharm is pleased to inform that José Ortiz, will be a speaker in the online 8th Annual Pharmacovigilance Symposium webinar with the theme “Redefining Pharmacovigilance Frontiers for Augmenting Healthcare”, carried out by Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR).
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.
We are happy to announce that PVpharm has been selected to provide safety support for a research project coordinated by the Catholic University of Louvain (UCLouvain) for a COVID-19 Phase II study. PVpharm will be supporting the clinical safety function with pharmacovigilance, report submission, safety report writing, Eudravigilance, CTIS and other PV and administrative related activities. PVpharm is providing support to Sponsors of clinical trials in the EU, please read more about our Pharmacovigilance services at https://pvpharm.com/pharmacovigilance/ Please contact us with any question https://pvpharm.com/contact/