The Clock Starts on DAY ZERO For Medical Literature Reports
“Marketing Authorization Holders (MAHs) are expected to review and assess reports of suspected adverse reactions from the medical literature to identify and record Individual Case Safety Reports (ICSRs).” If a pharmacovigilance case is detected in a journal, the clock starts on day ZERO of the receipt of the physical/hard copy of the local journal by […]
Proposals for MA annexes / registrations (SmPC, package leaflet, labelling)
ANSM is updating its MA style sheet to the « full » T10 format. This new version is dated January 19, 2023. The changes concern the address of the adverse reaction reporting site updated by the Ministry of Health https://signalement.social-sante.gouv.fr/ to replace www.signalement-sante.gouv.fr Find the new model to download on https://ansm.sante.fr/documents/reference/recommandations-relatives-a-la-redaction-des-projets-dannexes-de-lamm
Key Areas Addressed At Pharmacovigilance Conferences In 2022
2022 has been a busy year for the life sciences sector as we arise from the restriction and major impact of COVID. We had the opportunity to attend many events in person and online, and to learn, share and discuss a wealth of information and ideas with key stakeholders from all over the world. Here we […]
Revision of Good PharmacoVigilance Practices in France
We are pleased to share our summary of the revision of the Good Practices of PharmacoVigilance in France: although this revision does not bring major changes to the national system, it adds clarifications on the processes in place as well as an update of the description of the processes that have evolved since the previous […]
How to qualify for orphan designation in the European Union?
There are more than 7000 rare diseases affecting over 400 million people worldwide and 30 million people in European Union. However, only about 5% of rare diseases currently have approved treatments. As many of these diseases are life-threatening, there is a serious need to develop new drugs for rare diseases. Historically, drug development for rare […]
Webinar – 7 key points for a successful pharmacovigilance inspection
Language – French The pharmacovigilance inspection is one of the most important practice in terms of workload (preparation, implementation of action plans, etc.) and/or in terms of image (in the event of an injunction, for example). During a PV inspection, the pharmacovigilance system, and the involvement of all those stakeholders are scrutinized. This webinar aims […]
New incoming regulation update: In Vitro Diagnostic Regulation (IVDR) 2022
After a five year-long transition period, the IVDD (In Vitro Diagnostic Directive) will be replaced by the IVDR (In Vitro Diagnostic Regulation) on 26th May 2022 and will apply to all in vitro diagnostic devices marketed in EU Member States. The IVDR has the same basic requirements as the IVDD, but with some important improvements […]
Ask the Expert! A quick chat with Merih DURAMAZ, International Project Manager
Tell us about yourself and your job role at Universal Medica? I am a woman with multiple identities: first and foremost a mother of two toddlers, a life companion, a sister, a daughter, a third culture kid, a pharmacist, a manager of my team, an international project manager in medical information and vigilances and a […]
Strengths and limitations of remote pharmacovigilance audit
The emergence of COVID-19 and the economic consequences and travel restrictions that this pandemic has caused have led pharmaceutical companies to review their audit methods. Remote pharmacovigilance auditing has been implemented exponentially, but what are its Strengths and limitations? Strengths: Maintain audit planning (internal, contractors) in any circumstances (pandemic or other crisis situations…), more flexibility […]
Webinar – Universal Medica Group presents its solutions in Pharmacovigilance
PHARMACOVIGILANCE,
7 key points for a successful pharmacovigilance inspection
On 18/06/2020 at 17h30 (30 minutes).
Pharmacovigilance is one of the cornerstones of a drug’s life. On a daily basis, it enables the monitoring and prevention of the risk of adverse effects resulting from their use. The announcement of a pharmacovigilance inspection is an important step in the life of a pharmaceutical laboratory…
