Dr. Van Doren has over 22 years of industry clinical development, drug safety and risk management experience, has headed safety departments in several companies and is currently President & CEO of BioSoteria, a drug safety consultant services company.
Dr. Van Doren has over 22 years of industry clinical development, drug safety and risk management experience, has headed safety departments in several companies and is currently President & CEO of BioSoteria, a drug safety consultant services company.
Kala Paul is a neurologist with over 25 years of industry experience in product development/safety and expertise in risk communication with emphasis on health literacy. She received her MD Magna Cum Laude from the University of Texas and is a member of the FDA Risk Communication Advisory Committee.
Herbert Lee, Medcomm Solutions, LLC, United States
Dr. Lee has over 24 years of industry experience in drug information, medical affairs, clinical, regulatory and marketing. He has headed up medical information departments in several companies. Currently he is President of MedComm Solutions, an outsource contact center company for industry.
Description
This session will discuss and present information on which REMS communication tools have actually been shown to positively influence prescriber and patient knowledge and behaviors leading to mitigation of product risk in patients. Published papers on past communication effectiveness will be reviewed. The importance of what and how a communication is written will be discussed for effective communication practices. New innovative approaches to communication beyond paper information leaflets will be presented.
Learning Objectives: Discuss the current recommended REMS tools for mitigating risks to patients Compare what tools have been shown in past published studies to be effective (or not) in mitigation of patient risks Describe effective communication methods and new non-paper based patient and health care provider communication tools being used in practice.