Presenters: Ingrid Holmes, Vice President of Global Clinical Operations at Altasciences and Dr. Gary G. Kay, PhD, President of Cognitive Research Corporation
Join us for a complimentary webinar on when and how to use cognitive assessments, including the critical aspect of driving impairment, as a safety tool in early phase drug development.
What will you learn?
- Details about the FDA guidance and current trends from regulatory agencies for assessing cognition in first-in-human studies
- The classes of drugs that require CNS assessments, and methods for developing a robust CNS program in early stage clinical development
- How to determine the need for a dedicated driving study
- Types of study designs used for cognitive assessments
- The differences between dedicated driving studies using standardized driving simulators and European on-the-road driving tests
- How to ensure your drug meets the regulatory requirements
Vice President, Global Clinical Operations
Dr. Gary G. Kay, Ph.D.
Cognitive Research Corporation