Assessing the potential for impairment is an important and rapidly developing area of concern, both for the safety of patients, and those around them. Join us for a fact-based, timely examination of how assessing potential driving impairment or enhancement is performed, and what the results can mean for a new product in development.
What will you learn?
- FDA guidance details and what trends we have seen so far from regulatory agencies
- What classes of drugs require CNS assessments, when, how and their link to driving
- How to develop a robust CNS program in early stage clinical research
- How to determine when you will need a dedicated driving study
- Types of study designs used to evaluate different products
- Dedicated driving studies: standardized driving simulators vs. European on-the-road driving tests
- Sponsor perspective: meeting regulatory requirements, or differentiating your drug from the competition
Who may this interest?
- Drug development teams
- CNS researchers
- Clinical operations
- Outsourcing professionals
Dr. Ingrid Holmes
Vice President, Clinical Operations
Altasciences Clinical Research
Ingrid Holmes joined Altasciences Clinical Research in 2011, as Vice President of clinical operations of the Montreal site, a facility currently housing seven clinical units with 265 early phase beds, and a dedicated driving simulator unit. Additionally, Ingrid is responsible for the harmonization of clinical processes across Altasciences’ three sites, and acts as Global Compliance Lead within the Quality Management System.
Ingrid started her career in clinical research in 1995 at LAB Pharmacological Research. Over the years, Ingrid has held various management roles in Early Stage Clinical Operations, progressing to become Director of Business Operations and Continuous Improvement, overseeing the financial and quality performance of five international clinical sites. In her various roles, she has gained extensive experience in the conduct of Early Stage Trials, International Regulatory Requirements, Business Operations, Quality Management Systems and Lean Six Sigma.
Prior to joining Altasciences, Ingrid provided consulting services for early stage CROs and has successfully implemented company-wide management systems; including financial, client services and operational KPIs in a number of organizations.
Dr. Gary G. Kay
Cognitive Research Corporation
Gary G. Kay, PhD, is President of Cognitive Research Corporation, located in St. Petersburg, Florida. He is an Associate Professor of Neurology at Georgetown University School of Medicine. Dr. Kay is the author and publisher of the CogScreen-Aeromedical test battery and a pioneer in computer-based cognitive testing and development of driving simulation methodology for evaluating the impact of drugs on driving. Dr. Kay received his PhD in neuro-clinical psychology from Memphis State University and completed his clinical psychology internship at the U.S. Naval Hospital, Bethesda, Maryland. Dr. Kay is a diplomat of the American Board of Assessment Psychology and the American Board of Professional Neuropsychology. He is a Fellow of the National Academy of Neuropsychologists. He serves as a senior neuropsychology consultant to the U.S. Federal Aviation Administration and also serves as a consultant to airline medical departments, military medical organizations, other governmental agencies (e.g., National Highway Transportation and Safety Administration) and to the pharmaceutical industry. He has been an invited speaker at professional meetings across the globe. He was recognized by Medical Marketing & Media as one of the “Top 40 Healthcare Transformers of 2015.” He has published peer-reviewed articles that have appeared in American Psychologist, Archives of Internal Medicine, American Journal of Managed Care, Journal of the American Geriatrics Society, Human Psychopharmacology, Annals of Allergy, British Journal of Urology, and the British Journal of Pharmacology.
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