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"Safety and Risk Management in the Pharmaceutical Sector"
The pharmaceutical industry is caught in a safety storm that has gained strength since Merck pulled Vioxx from the market in 2004. This document by Best Practices, LLC looks at how the pharma industry has responded to heightened regulatory concerns surrounding safety and risk management. Additionally, the study examines the Risk Evaluation and Mitigation Strategy section of the Food and Drug Administration Amendments Act of 2007 and its implications for the industry. Regulatory leaders can use this study to see how other organizations approach the issues of safety and risk management.
Pharmaceutical; Biotech; Manufacturing; Consumer Products; Diagnostic; Medical Device; Health Care; Chemical
Alcon; Eli Lilly; United Therapeutics; Amgen; Bristol-Myers Squibb; Boehringer Ingelheim; Bayer; AstraZeneca Pharmaceuticals; Merck; Genentech; Valeant; Roche; Novartis; Solvay Pharmaceuticals; Medtronic