Universal Medica Group accelerates its growth with the acquisition of SH Consulting
Universal Medica Group, a leader in consulting and outsourcing services to the healthcare industries, acquires SH Consulting, a recognized player in Good Manufacturing Practice (GMP) compliance support for the pharmaceutical industry. SH Consulting offers audits, operational support, and training to its clients to meet the requirements of health authorities. This acquisition opens new perspectives for Universal […]
Webinar: Engaging Your Delegates Towards Professional Excellence
You have filled in a form on the universalmedica.com website to receive access to the replay of the following webinar: “Engaging Your Delegates Towards Professional Excellence”. 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 hesitate […]
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
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?
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 […]
European Medicines Agency (EMA) strengthens PRIME (Priority Medicines) with new features
The EMA is introducing new features to its Priority Medicines Initiative (PRIME) to support the development of medicines in areas of unmet medical need and speed up the approval process in the European Union. The new features include: Establishing a roadmap and product development tracker for each PRIME development. Providing expedited scientific advice specific to […]
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 […]
