The EMA recently issued a Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease. The latest revision of the guideline dates from...
Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation...
The European Alliance of Associations for Rheumatology (EULAR) has recently published updated recommendations for the treatment of systemic sclerosis (SSc) (Del Galdo et al, 2025). This publication puts forward that “SSc is a rare connective...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation...
Pour la 14e édition de notre enquête annuelle sur l’attractivité de la France pour la recherche clinique, nous appelons à l’action. Si le pays n’attire pas davantage les essais cliniques, c’est l’accès aux innovations pour...
Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation...
FDA has issued a draft guidance which provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. This guidance includes the following: Definitions for protocol...
Article 77(5) Medical Devices Regulation requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation...
As set out in the interim report of the pilot: In 2020, the joint Big Data Task Force of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published ten priority recommendations...
Diversity Action Plans are intended to increase enrollment of participants who are members of historically underrepresented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended use population....
