Journal américain de l'administration de médicaments et de la thérapeutique Libre accès

Abstrait

Global approach to Risk Management Plans �?? patient benefits with regulatory challenges

Robert Massouh

There are great advantages to implementing global risk management programs; from delivering core risk messages worldwide to implementing appropriate and robust risk minimisation measures. Health authorities worldwide are implementing risk management regulations at differing speeds, meaning Risk Management Plans and programs deriving from core company positions may have to be altered based on the local legislation. This may lead to regulatory and resource challenges in implementing risk management programs worldwide and commitments that do not align with the company position.