Tag Archives: REMS

New Focus of Pharma: Risk Management Throughout the Life Cycle of a Medicine

By Jim Mittler, PhD Creating a heightened focus on drug safety early in the drug development process is becoming the new paradigm for pharmaceutical companies. After hearing risk management...
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Building an Effective Global Risk Management and Drug Safety Program

By Jim Mittler, PhD Since 2007, the FDA has had the authority to require pharmaceutical companies to develop a risk evaluation and management strategy (REMS) for marketed products to ensure that...
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