Risk Management

Wendy Stephenson & Associates provide advice and support for the development and implementation of risk management plans, both pre- and post- approval, including:

• design and/or review of pre- or post-marketing risk management programs and plans, taking into account potential, anticipated or established risks based on pre-clinical and clinical data for the investigational or marketed product as well as known toxicities of other drugs in the class
• design and/or review of post-marketing pharmacovigilance plans, consistent with ICH E2E: Pharmacovigilance Planning and other local requirements
• design and/or conduct of epidemiology studies or registries for further evaluation of targeted safety issues
• labeling strategy, including core safety information, physician prescribing information and patient information
• review and/or development of educational plans and education materials for health providers, patients and caregivers, as well as a means for the ongoing evaluation of their effectiveness
• development of other risk minimization / risk mitigation strategies when needed, for example, limited distribution programs

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