Combination Products - Finding the Right Regulatory Strategy

Date(s) And Time(s):
Nov 9 2010 8:00AM - Nov 9 2010 5:00PM

Location:
Moevenpick Hotel Zuerich Airport
Walter Mittelholzerstrasse 8
8152 Glattbrugg
Switzerland

Overview:

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

Target Audience:
Who Will Attend
• Pharma and medical device industry
• Health authorities
• Notified bodies
• Regulatory, clinical and professionals responsible for developing combination products

Event Code:
10114

Contact Information:
DIA EUROPE
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG

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