Regulatory Rapporteur September 2020
Focus: Patient-focused development Plus: • Early access schemes: A heterogenous landscape with room for harmonisation • ICH Q3E: Virtual symposium on extractables and leachables • Patient information leaflets: Conveying complex information to patients
Regulatory Rapporteur September 2020 (full issue)MEMBERS
Interview: Theo Raynor - Communicating complex drug information to patients via PILsMEMBERS
Early access in the EU: a heterogeneous landscape with room for harmonisationMEMBERS
Do we need to involve patients in clinical study report lay summaries?MEMBERS
General Data Protection Regulation and patients enrolled in EU clinical trialsMEMBERS
Interview: Robyn Bent - Incorporating patients’ voices in the drug development processMEMBERS
A look back at 30 years of changes in EU legislation in drug development for rare diseasesMEMBERS
Meeting report: ICH Q3E (extractables and leachables): Setting the scene – part 1 PUBLIC
Patients are the reason for all that we do PUBLIC