Combination Products - Finding the Right Regulatory Strategy

Venue: Moevenpick Hotel Zuerich Airport

Location: Glattbrugg, Switzerland

Event Date/Time: Nov 09, 2010
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Description

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 framework 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



Event Code:
10114

Venue

Walter Mittelholzerstrasse 8
Glattbrugg
Switzerland
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