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Results for: High-quality studies - Regulatory - Europe
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Competitive Edge - Ulcerative Colitis
Case Study — February 2, 2011
Although faced with the challenge of recruiting for this small patient population, enrollment was completed two months ahead of schedule. -
25 Years of Regulation - and Still Failing - Risky Business, Chapter 4
Hear from the Experts — February 2, 2011
Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter four identifies two simple principles needed for the improvement of quality management in pharmaceuticals today: managing consistency and maintaining responsiveness. -
The Value of Reviewing Existing EU Risk Management Plans
Media Coverage — February 12, 2010
Drug Safety experts Cheryl Key, Barry Mulchrone and Karen Wai describe an electronic database for tracking RMPs for drugs approved in the European Union and explain why it is crucial for sponsors submitting marketing applications to have a thorough knowledge of safety plans already required for similar products.
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