June 13, 2012
Pharmaceutical Risk Management Lessons from the Airline Industry
In May 2012, the Institute of Medicine issued a Report Brief describing the content of a new report they released in a pre-publication version entitled, Ethical and Scientific Issues in Studying the Safety of Approved Drugs. The document provides many recommendations to the FDA that, if implemented, would significantly change the way the benefits and risks of medications are proactively evaluated, tracked, and periodically reported in the United States. Importantly, these recommendations are consistent with pharmacovigilance legislation being implemented in the EU beginning in July 2012. This report is a "must-read" for risk management professionals and all pharmaceutical industry leaders.
Context of the IOM report
Summary of recommendations
Implications for risk management professionals and policy in the pharmaceutical industry
- Jeff Fetterman - President, ParagonRx
Watch the video
About the Speakers
Captain Ben Berman is a senior research associate at San Jose University/NASA Ames Research Center and a recognized expert in the area of risk mitigation and management in the airline industry. The former Chief of Major Investigations of the U.S. National Transportation Board, Captain Berman previously led the Operational Factors Division, serving as a member of the major accident go-team responsible for flight operations and safety studies.
Jeff Fetterman is President and CEO of ParagonRx. As co-author of two pharmaceutical risk management books and consultant for numerous risk management programs, he is helping to pioneer this emerging field in our industry. Having led the pre-startup safety assessment of the only nuclear reactor to be renovated following deactivation, Jeff is familiar with the cross-industry implications of risk management techniques.
To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email email@example.com