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FDA Clinical Investigator Training Course (CITC) 2023 (Day 1)
December 6, 2023 @ 11:00 am - 4:30 pm EST
FDA Clinical Investigator Training Course (CITC) 2023
Day 1: Wed, Dec 6 2023 11:00 AM – 4:30 PM ET
Day 2: Thu, Dec 7 2023 11:00 AM – 4:00 PM ET
Click Here to register and learn more!
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
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
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