EudraVigilance is an EU web-based information system, designed to manage safety report data created by the European Medicines Agency (EMA) containing adverse reaction reports (ADRs) for medicines authorised in...
HTA bodies carry out clinical effectiveness assessments, in which new technologies are compared with the standard of care and other existing treatments.
In Phase II trials, the investigational medicinal product is tested for efficacy (and safety). The studies conducted are typically therapeutic exploratory studies which try to discover whether the medicine...
Published and available for citation: Hunter A, Facey K, Thomas V, Haerry D, Warner K, Klingmann I, May M and See W (2018) EUPATI Guidance for Patient Involvement in...
When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability,...
Introduction A Polish breast cancer patient’s organisation contacted Novartis for information on conducted clinical trials with the aim to publish the information in their site. Investigators were informed and...
Raising Awareness on Managing Competing Interests in a Multi-Stakeholder Environment: Guidance to Patients and Engaging Stakeholders – download the guidance below Background/Rationale for the document Managing competing interests and...
The development of Medical Devices should involve patients and the public throughout each stage: innovation, assessment, implementation and evaluation.This is essential in order to ensure that Medical Devices address...
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