Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap

Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap | Stegemann et al Read more…

Guidance for Patient Involvement in Regulatory Processes

Guidance for Patient Involvement in Regulatory Processes Guidance for Patient Involvement in Regulatory Processes | EUPATI “This guidance for PAGs covers patient involvement in the regulatory field and draws on the mature “Framework for interaction between the European Medicines Agency and patients and consumers and their organisations” “”Guidance for patient Read more…

How-to Guide on Patient Engagement in Clinical Trial Protocol Design

How-to Guide on Patient Engagement in Clinical Trial Protocol Design How-to Guide on Patient Engagement in Clinical Trial Protocol Design | PFMD “PFMD: The guide will give more clarity, instructions and the key terminology to Patients, Carers, Patient Organizations, Industry (Pharma, Biotech, Devices), Academia, Researchers, Contract Research Organisations (CROs) on Read more…

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