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 CNIL guidelines for the processing of personal data in the healthcare sector: Compliance with the GDPR and French legislation
The CNIL (Commission Nationale de l’Informatique et des Libertés, the French data protection authority) has published guidelines for healthcare organisations on the processing of personal data. The guidelines outline the criteria that these organisations must meet in order to obtain valid consent from individuals for the processing of their data. They also specify the information […]
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 […]
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
The European Commission proposes an extension of the transitional period for the re-certification of medical devices
On 06 January 2023, the European Commission proposed an extension of the transitional period for the re-certification of medical devices in order to reduce any risk of shortages. There are at present more than 500,000 types of medical devices on the EU market, ranging from simple contact lenses and plasters to pacemakers and hip replacements, […]
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 […]
