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Agenda

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ABOUT THIS CONFERENCE

This course is designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.

TOPICS COVERED

• Design and conduct of clinical trials
• Determining appropriate endpoints in clinical trials
• Efforts to advance diversity in trial populations
• Statistical evaluation of clinical trials
• Innovative trial designs
• Interpretation of the investigator brochure
• Clinical trial quality

INTENDED AUDIENCE

This is a clinical investigator training course targeted to all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local and foreign).The course is designed for clinical investigators, health care professionals (physicians, nurses, pharmacists, other healthcare workers), and individuals involved in biomedical research and the development of medical products.

FDA RESOURCES

• Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biologic Products Guidance for Industry – Draft Guidance
• Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biologic Products – Draft Guidance
• Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations – Draft Guidance