Regulatory Rapporteur November 2020
Focus: A look across the Atlantic - Exploring topics ranging from new FDA guidances and regulations to Health Canada’s current framework Plus: • Regulatory intelligence: Automated approach to text mining and curation • Early access schemes: Overview of programmes across EU member states • Medical devices/IVDs: Latest standards update
Regulatory Rapporteur November 2020MEMBERS
Meeting Report: TOPRA/RAPS Workshop on Alignment of Global Combination ProductsMEMBERS
Interview: Regulating healthcare products in CanadaMEMBERS
FDA issues guidance for 2017 final rule on penalties related to Clinicaltrials.gov databaseMEMBERS
Early access in the EU: a heterogeneous landscape with room for harmonisationMEMBERS
Medical device standards updateMEMBERS
How the modernisation of FDA’s New Drugs Regulatory Program enhances transparency and consistencyMEMBERS
Text mining for regulatory intelligence: taking an automated approach PUBLIC
Editorial: Winning the regulatory race against time PUBLIC