Combination Products Workshop – Regulatory Overview for Drug/Device Combinations and Drug/Companio

Venue: Hotel Bildungszentrum 21

Location: Basel, Switzerland

Event Date/Time: Sep 18, 2012 End Date/Time: Sep 18, 2012
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Overview This one-day conference will provide delegates with an understanding of the regulatory framework for drug/device combinations and drug/companion diagnostics, taking into account the latest revision of the European medical device and in-vitro diagnostics (IVD) legislation. It will focus on the differences between device and pharma regulations and will highlight challenges facing manufacturers who operate on the drug/device borderline where it is not immediately obvious which regulatory framework applies.

Featured Topics
• Overview of regulatory framework in the EU and US for combination products
• Update on European law affecting drug/device/IVD regulations
• Competent authority and notified body views on their roles in regulating drug/device combinations and drug/companion diagnostics
• Regulatory challenges in developing combination products and drug/companion diagnostics
• Case studies

Who Should Attend
• Pharma, medical device and diagnostic industry professionals
• Health authority representatives
• Notified body representatives
• Regulatory, clinical and other professionals responsible for developing drug/device combinations and companion diagnostics

Learning Objectives
• Highlight regulatory options and routes that are available to manufacturers developing drug/device combinations and drug/companion diagnostics
• Give an overview how the latest EU regulatory developments impact drug/device combinations and companion diagnostics
• Provide an open forum to discuss the relative merits and drawbacks between the different regulatory frameworks

Program Committee
Carole Burnier
Regulatory Affairs Manager
Novartis Consumer Health SA, Switzerland
Shayesteh Fuerst-Ladani, MBA,MS
SFL Regulatory Affairs and Scientific Communication, Switzerland