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Session 1: Regulatory Updates and Experiences
Session Chair(s)
Representative Invited
FDA, United States
The FDA has played a major role in guiding and collaborating with researchers to promote the efficient and safe development of drugs. This session focuses on regulatory updates, including a new FDA’s initiative and two recently published FDA guidance documents for industry on the design and conduct of clinical trials.
Learning Objective : - Describe structure and functionality of the FDA’s new initiative on clinical trial innovation
- Explain key elements of the adaptive clinical trials included ICH E20
- Apply statistical aspects of benefit-risk assessments for new drug and biological products
Speaker(s)
The Mission of the New Initiative on Clinical Trial Innovation (C3TI) at FDA
Representative Invited
FDA, United States
Guidance Document on ICH E20: Adaptive Clinical Trials
Representative Invited
FDA, United States
Guidance Document on Benefit-Risk Assessments for New Drug and Biological Products
Representative Invited
FDA, United States
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