POST CONFERENCE
WORKSHOP ON DRUG /
DEVICE & DEVICE
/ DRUG COMBINATION
PRODUCTS IN THE EU

Conference Date: 24 Mar 2010
Conference Ref: N3-8110
Fee: £545 + VAT
Venue: The Cavendish Hotel, London

Discounted rate if booked with INJECTABLE DRUG DELIVERY on 22 March 2010 - Ref N3-8010

Introduction/Aim 

This seminar will focus on the EU regulations for drug/device and device/drug combination products including needle-free, pen and auto injectors in addition to other combination products. It will provide an excellent opportunity for delegates to understand the complex regulations and will assist in establishing the best regulatory route for their product to achieve success in the European market.

Delegates will have the opportunity to send specific queries in advance of the event to ensure they are addressed at the seminar.

With:
Dr David Jefferys, Vice President, Global
Regulatory, Eisai R&D Management Co. Ltd, UK
Dr Brian James, Managing Director, Interface
International Consultancy, UK

PROGRAMME

Welcome and Introduction

EU Regulatory Framework andGuidance

Roles of Key Bodies

• Notified Body expectations
• Member States
• EMEA’s view point

Defining the Regulatory Approval Route for Your Product Differences in Documentation

• Device
• Drug and device
• Device and drug

Quality Systems for Combination Products

• Quality, pre-clinical and biocompatibility issues: how to address these for combination products
• What kind of non-conformance can we expect if you combine a drug and device?

Clinical Trial Considerations

Vigilance vs Pharmacovigilance

European Approvals Outside the EU

• Life Cycle management
• Global structure
• Using the EU as part of a wider global strategy

Close of Forum

Click here to book your place.