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YT 16 minutes 56 seconds U.S. Food and Drug Administration Orange Book: 101 An Overview (11of27) Generic Drugs Forum 2018 YT 46 minutes U.S. Food and Drug Administration Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017 YT 4 minutes 12 seconds U.S. Food and Drug Administration The Basics of Biosimilars

YT 29 minutes 45 seconds U.S. Food and Drug Administration Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020 YT 58 minutes 43 seconds U.S. Food and Drug Administration So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020 YT 58 minutes 49 seconds Duke University School of Medicine Investigational New Drug Application (IND) Forms: Updates and Best Practices

YT 1 hour 19 minutes 35 seconds U.S. Food and Drug Administration Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018 YT 1 hour 31 minutes 6 seconds GlobalCompliance Panel The FDA Drug Development Process: GLP, GMP and GCP Regulations YT 1 hour 50 seconds U.S. Food and Drug Administration CDER FDA Exclusivity – Which One Is for Me? - June 10, 2019

YT 34 minutes 20 seconds U.S. Food and Drug Administration A Medical Officer’s Approach to NDA/BLA Review (8of15) REdI Annual Conference – May 29-30, 2019 YT 41 minutes 30 seconds U.S. Food and Drug Administration Meetings: Pre-submission and Special Programs (4of15) REdI Annual Conference – May 29-30, 2019 YT 45 minutes 22 seconds U.S. Food and Drug Administration Application Case Studies on FDA’s Action Letter Timing (16of16) GDF 2020

YT 5 minutes 20 seconds U.S. Food and Drug Administration Data Requirements for Biosimilars YT 1 second [Private video] YT 21 minutes 6 seconds European Medicines Agency Quality aspects in investigational medicinal product developments

YT 1 hour 6 minutes 44 seconds European Medicines Agency Module 05 - Clinical trials in the EU YT 1 hour 11 minutes 26 seconds European Medicines Agency Module 01 - Setting the scene: introduction to the EU regulatory network YT 1 hour 13 minutes 29 seconds European Medicines Agency Module 04 - ATMPs

YT 31 minutes 50 seconds inglasia pharma solutions An Introduction to Good Manufacturing Practice - Pharmaceutical and Biotechnology Industry YT 1 hour 12 minutes 3 seconds Compliance Insight 21 CFR, Parts 210 and 211