How Generative AI is Transforming Pharmacovigilance
Pharmacovigilance, the science of monitoring and evaluating the safety and promoting the efficacy of medicines, plays a vital role in safeguarding public health. In the ever-evolving world of pharmacovigilance, cutting-edge technologies are reshaping safety monitoring as we know it. Artificial Intelligence (AI) is at the forefront of this transformation, and within AI, Gen AI (Generative […]
National Requirements for the Local Person for Pharmacovigilance (LPPV) in the EU, UK and Switzerland
LCPPV REQUIREMENTS IN EU, CH & UK GUIDE
Simplified reporting procedures for monitoring the safety of clinical trials: simplified procedures for sponsors
From 22 May 2023, clinical trial sponsors will be subject to new, simplified procedures for declaring the vigilance of the medicinal products tested, in accordance with the Jardé law. The changes are as follows: Reporting of Suspected Unexpected Serious Adverse Reaction (SUSAR): from now on, these incidents must be transmitted exclusively electronically to the European […]
Webinar – Requirements for a local contact person for pharmacovigilance: where do you need one?
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Shaping the future together: discover the Universal Medica Group’s new webinar series!
At Universal Medica, we firmly believe that the exchange of information and experiences is vital for establishing strong business partnerships. That’s why we are thrilled to announce our upcoming webinar series titled “Shaping the future together“. These webinars offer a unique opportunity to explore with you some of the key areas in life sciences. We’ll […]
Forthcoming changes to accessing and managing EudraVigilance
The EudraVigilance system will undergo several updates over the next few months to improve its security and user management processes. These updates include: Multi-factor authentication (MFA): The European Medicines Agency (EMA) has already implemented MFA for some of its systems and plans to enable it for access to EudraVigilance in March 2023, followed by EVDAS […]
The MDCG clarifies important vigilance terms and concepts in the new MDR
The Medical Device Coordination Group (MDCG) has clarified important vigilance terms and concepts used in the MDR in order to provide a common understanding of these terms and concepts necessary for an effective and harmonised implementation of vigilance requirements. Some of the definitions have been reintroduced from the Medical Devices Vigilance Guidance, modified where necessary […]
How does E2B improve stakeholders access to ICSR data electronically?
How does E2B improve stakeholders access to ICSR data electronically? The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published a short training video on the electronic transmission of ICSRs in E2B (R3) format. This video explains why this format was developed, and its advantages in the exchange of […]
Ways to reduce the influence of promotional activities on health products
The French National Authority for Health (HAS) has recently published a press release on possible ways to reduce the influence of promotional activities on health products. The meeting between health professionals and industry representatives for the promotion of health products is regulated in various ways around the world. In order to establish a state of […]
Re-evaluation of the “Pregnancy” pictogram
The ANSM has just created a temporary scientific committee (CST) “Re-evaluation of the pictogram on the outer packaging of teratogenic or foetotoxic medicinal products” for the re-evaluation of the process concerning the pictogram “Pregnancy” currently mentioned to certain boxes of medicinal products or products whose SmPC mentions teratogenic or foetotoxic effects. To learn more, please […]
