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AGENDA

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ABOUT THIS EVENT

This course is designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products. Participants will acquire a practical understanding of:

• FDA’s approach to trial design
• Safety concerns in the development of medical products
• Statistical issues in the analysis of trial data
• Clinical investigator responsibilities

INTENDED AUDIENCE

This is a clinical investigator training course targeted at all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign). The agenda is designed for:

• Clinical investigators
• Health care professionals (physicians, nurses, pharmacists, other healthcare workers), and
• Individuals involved in biomedical research and the development of drugs and biological products.

TOPICS COVERED

• Design and conduct of clinical trials
• Innovative trial designs
• Considerations for rare disease drug development
• Enhancing diversity in clinical trials
• Addressing specific populations in drug development
• Statistical evaluation of clinical trials
• Understanding the investigator brochure
• Clinical trial quality

FDA RESOURCES

• Draft Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
• Final Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

Session Recordings:

• Day One YouTube Livestream Recording
• Day Two YouTube Livestream Recording