ACDRS 2024 Session 5 - Global Clinical Trials Authorization and Marketing Authorization Processes

This is Session 5 of 6. Must register for the entire 2024 Course and not per session.

Session Co-chairpersons:
Daniela Drago, PhD RAC FRAPS FTOPRA, Expert Consultant, NDA Partners
Christine E. Garnett, PharmD, Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (US FDA)

Topics (subject to change)

• US FDA applicable laws, regulations, and guidance documents
• FDA’s Center for Drug Evaluation and Research (CDER) new drug clinical trial and marketing authorization review processes
• US benefit-risk methodology and considerations
• US labeling requirements
• US regulatory outcomes and appeals
• US regulatory approaches to post-marketing
• US regulatory requirements for rare diseases and gene therapies
• Challenges with and approaches to multi-country clinical trials
• US FDA advisory committee meetings and CHMP oral explanations
• FDORA, PDUFA VII, and their impact on US FDA-regulated industry and US FDA
• Starting a clinical trial and obtaining scientific advice in the European Union, China, and other countries
• Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), National Medical Products Administration (NMPA) of China, and the US FDA
• Corporate social responsibility
• Real-world data and real-world evidence
• Artificial intelligence and machine learning