Pharmacovigilance services provided by PVpharm
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.
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…
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…
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 José Ortiz, PVpharm's CEO will be participating in one session of the 2021 Pharmacovigilance symposium organized by AEFI. During the session, José will be talking about outsourcing of pharmacovigilance activities. Please take a look to the program at this link: https://www.aefi2021.com/
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/
PVpharm provides the Local Contact Person for Pharmacovigilance (LCPPV) in all EU countries and UK, besides we can also provide the EU Qualified Person for Pharmacovigilance (EU QPPV), UK QPPV and and Deputy persons with large knowledge and experience of the industry. Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH's PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with…
Vojtech Kvita from PVpharm participates as speaker in the Clinical Trial Regulation Information Day for CEE Countries. The Clinical Trial Regulation Information Day provides a forum to prepare stakeholders from Central and Eastern European Countries for the implementation and launch of the new EU Clinical Trial Regulation (536/2014) which will replace the European Clinical Trials Directive (2001/20/EC). The Information Day will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes. It further aims to provide a platform for discussion about the compliance with the new Regulation and associated implementing acts in…
PVpharm provides EU Qualified Person for Pharmacovigilance (EU QPPV) and Deputy EU QPPV with large knowledge and experience of the industry. Besides, PVpharm has contact persons for pharmacovigilance in several EU countries Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH's PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with the legal requirements.The EU QPPV has the following responsibilities regarding…