Improved Development and Regulation of Transdermal Systems

Venue: Sheraton National Hotel Arlington

Location: Arlington, Virginia, United States

Event Date/Time: Sep 15, 2011 End Date/Time: Sep 16, 2011
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The first US transdermal drug delivery system (TDDS) was approved by the FDA more than 30 years ago. Despite this length of time and the advancement of science in many other pharmaceutical fields, little has changed or evolved in the development, control and regulation of these products. Over the years, various product quality problems have been reported by patients and practitioners. Some of these quality problems have safety and efficacy implications that have led to the recall of numerous batches of products and, in some cases, the temporary or permanent removal of the product from the market. This FDA-cosponsored workshop will offer a multidisciplinary and crossfunctional look at TDDSs to improve the development, design, manufacturing, quality, clinical performance, safety and regulation of these products.

Featured Topics
• FDA Perspective on Clinical Development, Regulatory Consideration, Safety and Quality Considerations
• Challenges in Development of TDDS and New Technologies
• Regulatory Issues
• QbD Aspects

Co-sponsored by FDA and DIA

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