Pharmaceutical Risk Management

ParagonRx^® excels in supporting the development, approval, and commercial success of pharmaceutical brands that have been associated with serious and/or frequent adverse events. Increasingly, such products require additional monitoring and management activities by clinicians, pharmacists, and patients.

Risk management is an emerging regulatory requirement whereby FDA expects pharmaceutical companies to propose plans that proactively manage the safety risks of drugs as an integral part of the NDA submission or life-cycle management. Typical risk management issues have included fetal abnormalities, QTc prolongation, hepatotoxicity, drug-drug interactions, polymorphic metabolism, and drugs with abuse potential. This new discipline entails risk detection and assessment, intervention program development and implementation, and post-launch evaluation of program effectiveness.

RiskMAPs

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