108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins

On this episode I was joined by Margaret Jenkins, who's the Founder and Principal at Global Pharma Solutions. Margaret and I discuss: Clinical Data interpretation and authoring eCTD Module 2 Overview Learning drug assays with a device background Non-Clinical eCTD Module 4 Clinical eCTD Module 5 Margaret Jenkins is the Founder and Principal at Global Pharma Solutions where she works closely with clients to provide strategic solutions, allowing them to follow the most efficient pathway to registration and launch in their chosen markets. Margaret has more than 30 years’ experience in the Pharmaceutical industry both in the UK and Australia, spanning drug discovery, drug development and Regulatory Affairs.Margaret has hands-on experience in numerous successful global submissions in both the innovator and generic spaces for: US, EU, Asia Pacific and ANZ. Margaret has written all 5 modules of the CTD including writing clinical overviews and summaries, several module 3s (CMC), and summarizing pre-clinical reports.