Global Clinical Trials Authorization & Marketing Authorization Processes
Co-chairs: Daniela Drago, NDA Partners & Christine Garnett, US FDA
Details
- Type Event
- Date -
- Time -
- Location University of California Washington Center Multipurpose Room, 1st floor
About
Must be registered in advance to attend.
Topics
- US FDA applicable laws, regulations, and guidance documents
- FDA’s new drug clinical trial and marketing authorization review processes
- US benefit-risk methodology and considerations
- US labeling requirements
- US regulatory actions and outcomes for NMEs, NDAs, and BLAs
- US regulatory approaches to post-marketing
- US regulatory requirements for rare diseases, pediatric therapeutics, and cell & gene therapies
- Challenges with and approaches to multi-country clinical trials
- US FDA advisory committee meetings and CHMP oral explanations
- CMC section of regulatory applications
- FDORA, PDUFA VII, and their impact on US FDA-regulated industry and US FDA
- Starting a clinical trial and obtaining scientific advice in the EU, Japan, China, and the US
- Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency of Japan, National Medical Products Administration (NMPA) of China, and US FDA
- Enhancing diversity in clinical trial populations
- Real-world data and real-world evidence
- Artificial intelligence and machine learning
Topics subject to change