DRUG / DEVICE &
DEVICE / DRUG
COMBINATIONS IN THE
EU

Conference Date: 20-21 Oct 2010
Conference Ref: N10-8010
Fee: £1220 + VAT
Venue: The Rembrandt Hotel, London

INTRODUCTION

The demarcation between medicinal products and devices is becoming ever more important. In addition, with the convergence of emerging novel technologies the number of drug/device combination products and medical devices incorporating amedicinal substance are increasing. At the same time cell therapy and tissue engineered products are being combined with both pharmaceuticals andmedical devices. This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.

WHO SHOULD ATTEND

Development and regulatory personnel in the medical device, pharmaceutical and diagnostic industries, who are interested in medical devices incorporating ‘pharmaceutical’ ingredients, or pharmaceutical products incorporating a device or delivery system.

Chairman:

Dr David Jefferys Vice President. Global Regulatory, Eisai R & D Management Co. Ltd. UK

Speakers:

Elizabeth Baker Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA, UK
Dr Brian James Managing Director, Interface International Consultancy, UK
Theresa Jeary Certification Manager, BSI Product Services, UK
Mark Kramer President, Regulatory Strategies, Inc., USA
Alison Wilson Principal Consultant, CellData Services, UK

TOPICS TO BE COVERED

• Understand the European Regulatory Guidance
• Know What Your Competent Authority Expects
• Gain an Insight into Notified Bodies Considerations on Drug/Device Products
• Learn How to Define the Approval Route for your Product Take Away the Major Differences in Documentation and Approval Routes
• Consider Quality System Requirements for Combination Products
• Discover FDA’s Regulatory Approach to Combination Products
• Hear How to Deal with Human Tissue Engineered Products
• Stay Up-to-Date on Post Market Surveillance for Combination Products

Click here to book your place.

Discounted rate if booked with Biological Evaluation of Medical Devices on 18-19th October 2010.  Click here to find out more