A Framework for Pharmaceutical Risk Management

Jeffrey E. Fetterman, Wendy K. Nickel, Wayne L. Pines, Gary H. Slatko, M.D.

Risk management is an emerging regulatory requirement for pharmaceutical companies. Risk management means that companies must assess the degree of risk posed by adverse events and implement interventions around their products to assure safe use by the patient.

Risk management programs can be as simple as educational outreach, or as complex as restricted distribution and informed consent requirements. They will have a significant impact on the way pharmaceutical products will be developed, filed and marketed.

A Framework for Pharmaceutical Risk Management explores the history and current status of pharmaceutical risk management programs, and puts them in the context of risk management practices in other industries. It also recommends a systematic way for pharmaceutical company executives, the government, and healthcare providers to approach risk management.

The book helps to answer key questions and provide direction for program development, such as:

• How do pharmaceutical companies conduct a risk assessment?
• What have other risk-intensive industries done in the areas of risk assessment and risk management?
• Why haven't elements from previous or existing pharmaceutical risk communication programs been effective?
• What do I need to know about measurement and reporting systems, and intervention programs?

Now available from FDLI:

The complete table of contents and order information is available at the FDLI web site, www.fdli.org.

FDLI is a nonprofit educational organization dedicated to improving the understanding of the laws, regulations and policies affecting food, drugs, medical devices, biologics and cosmetics.

Source: Food and Drug Law Institute