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Fast Facts

Conference on Combination Products

Finding the Right Regulatory Strategy
Nov 09,2010 - Nov 09,2010
Moevenpick Hotel Zurich-Airport, Glattbrugg, Switzerland
 

Highlights

This one-day conference will provide delegates with an understanding of the regulatory framework and highlight the 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 frame-work is not immediately obvious.

Key Topics
• Overview of regulatory framework in EU and US for combination products
• Challenges in developing combination products
• Competent Authorities and Notified Bodies view on their roles regulating combination products
• The political tug of war between drug and device regulations and strategic moves at European Commission level
• Case studies











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Event Profile

Theme: Finding the Right Regulatory Strategy
Attendees: Pharma companies and medical device manufacturers, Health authorities, Notified bodies, Regulatory, clinical, and project professionals responsible developing combination products

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