Product/Service
Conference On Drug & Device Combination Products - Finding The Right Regulatory Strategy
•Event Brochure: Conference On Drug & Device 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 - Zurich
Switzerland
Interest Area(s):
Pharmacology,Regulatory Affairs,Research & Development,Clinical Research,Project Management,Quality Assurance/Quality Control,Strategic Planning
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 Authority and notified body views on their roles in regulating combination products
- Strategic moves affecting drug and device regulations at the European Commission level
- Case studies
•Event Brochure: Conference On Drug & Device Combination Products – Finding The Right Regulatory Strategy
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