Combination Products - Finding the Right Regulatory Strategy
|Event Date/Time: Nov 09, 2010|
challenges developing combination products. It will focus on the differences between device and pharma regulations and will provide examples of issues faced by manufacturers already operating on the medicinal product/medical device borderline, designing products where the regulatory framework is not immediately obvious.
â€¢ Overview of regulatory framework in EU and US for combination products
â€¢ Challenges in developing combination products
â€¢ Competent Authorities and Notified Bodies view on their roles regulating combination products
â€¢ The political tug of war between drug and device regulations and strategic moves at European Commission level
â€¢ Case studies