Risk Management and Drug Safety Summit

Dozens of drug and biologics manufacturers are required to submit Risk Evaluation and Mitigation Strategy (REMS) plans by Sept. 21. New international regulations are under development to shape effective global risk management programs. Improved tools, including registries and large streamlined studies, are being utilized to improve postapproval safety surveillance. And with penalties for failure to adhere starting at $250,000 and potentially reaching $10 million, lacking proper drug safety protocols is not an option.