Safety and Risk Management in the Pharmaceutical Sector

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"Safety and Risk Management in the Pharmaceutical Sector"

STUDY OVERVIEW
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.

KEY TOPICS

• Refocusing on Safety
• Risk Evaluation and Mitigation Strategies
• Changing Safety Landscape

• Program Changes in Response to FDA's Increased Emphasis on Safety
  

• Consider Hiring more Safety Experts to Address FDA Safety Priorities
• Pay more Attention to FDA Safety-Related Requests to Speed Review Process
• If Safety Issue comes up, go to FDA with a Plan to Address it

Industries Profiled:
Pharmaceutical; Biotech; Manufacturing; Consumer Products; Diagnostic; Medical Device; Health Care; Chemical


Companies Profiled:
Alcon; Eli Lilly; United Therapeutics; Amgen; Bristol-Myers Squibb; Boehringer Ingelheim; Bayer; AstraZeneca Pharmaceuticals; Merck; Genentech; Valeant; Roche; Novartis; Solvay Pharmaceuticals; Medtronic

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