The Future of Safety Signal Detection and Risk Management

Pharmaceutical Executive Global Digest
August 2014
Author: Dr. Suhasini Sharma, Sciformix Corporation

New drugs are placed on the market with limited clinical experience of safety. Healthcare companies and regulators have an ethical and a legal obligation to monitor safety of drugs throughout their life cycle, and safeguard public health by identifying risks associated with their use and putting in place
appropriate risk mitigation measures.

Post-marketing pharmacovigilance helps detect new safety issues and rare adverse reactions associated with use of drugs in actual clinical use. Safety signal detection is an important component of pharmacovigilance. It is an ongoing process and plays a critical role in risk management for healthcare
products.

Safety signals thus identified, are evaluated, monitored and confirmed, mandating appropriate risk mitigation measures.

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