Risk Management in premarketing phase . Anshu Vashishtha MD PhD [email protected] (in individual capacity employer : Watson Pharmaceuticals). Role of Investigator Brochure in Risk Management in Development. Major instrument of risk management during this phase is the investigator’s brochure(IB).
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Major instrument of risk management during this phase is the investigator’s brochure(IB).
Organization of safety information in the IB needs to be enhanced to improve risk management using CIOMS concept of Developmental Core Safety Information (DCSI).
Investigators need to accurately understand likelihood of risk and frequency of risk to be able to understand and manage it
*Guidelines for preparing Core Clinical Safety Information on Drugs, Second Edition Report of CIOMS Working Groups III and V including New Proposals for Investigator’s Brochures , Geneva 1999