EMA wants to strengthen the collaboration with HTAs to reinforce patient relevance in evidence generation
Highlights on EMA’s focus to advance patient-centred access to medicines in partnership with healthcare systems. In EMA’s Regulatory Science Strategy to 2025, the EMA presents...Read More
Increased interest from EMA to enhance the incorporation of patients’ voices into drug development. As part of the EMA’s Regulatory Science Strategy to 2025, EMA proposes…Read More
Are you developing drugs in accordance with regulatory guidances on Patient-Focused Drug Development?
The FDA and the EMA are strengthening Patient-Focused Drug Development. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both acknowledge that…Read More
The limitations of Patient Reported Outcome Measures (PROMs). Traditional PROMs (consisting of closed-end questions) have for many years been applied to reveal the patients’ experiences of effects…Read More
Get the full picture of a treatment. To ensure that you get a clearer picture of a treatment, we recommend interviewing the users who are exposed to a drug candidate as early as possible in the trial…Read More