Designing a patient-centric protocol

Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation

Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation | PFMD “A practical guide for collaborative development of plain language summaries (PLS) for peer-reviewed publications and conference Read more…

By Lindsey, ago

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…

By Lindsey, ago

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…

By Lindsey, ago

Patient Engagement in Medicines Development: Recommendations on how to find the right match for the right patient engagement activity

Patient Engagement in Medicines Development: Recommendations on How to Find the Right Match for the Right Patient Engagement Activity Patient Engagement in Medicines Development: Recommendations on how to find the right match for the right patient engagement activity | IHI (formerly IMI) PARADIGM PARADIGM: Guidance for Industry and PAGs providing Read more…

By Lindsey, ago

ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development

ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development | ICH Importance of bringing patient perspective in clinical research a series of drug development and regulatory decision-relevant questions that arise during the drug Read more…

By Lindsey, ago

Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials

Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials | CTTI and FDA Workshop on ideas for best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, Read more…

By Lindsey, ago