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 […]
Webinar: Outsourcing of the LEA, a Response to Regulatory Complexity
You have filled in a form on the universalmedica.com website to receive access to the replay of the following webinar: “LEA outsourcing, a response to regulatory complexity”. Click on the link below to view it: REPLAY If you have any questions or would like to have a brief discussion on this subject, please do not […]
National Requirements for the Local Person for Pharmacovigilance (LPPV) in the EU, UK and Switzerland
Thank you for downloading our updated guide on National Requirements for the Local Person for Pharmacovigilance (LPPV) in the EU, UK, and Switzerland. You can open the document by clicking on the link below. LPPV REQUIREMENTS IN EU, CH & UK GUIDE We hope you find this resource helpful in navigating the recent updates from […]
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?
You have filled in a form on the universalmedica.com website to receive access to the replay of the following webinar: Requirements for a local contact person for pharmacovigilance: where do you need one? Click on the link below to view it: REPLAY: WATCH NOW
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 […]
The implementation of the European regulation on medical devices
The implementation of the European regulation on medical devices has taken a major step forward with the adoption of a proposal by the European Commission to adapt its transitional provisions. The amendment to the Medical Device Regulation modifies Article 120 to maintain the validity of certificates issued under the directives and allow marketing of corresponding […]
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 […]
