FDA REQUIREMENTS FOR
COMBINATION PRODUCTS

Conference Date: 29 Sep 2010
Conference Ref: N9-8110
Fee: £545 + VAT
Venue: The Rembrandt Hotel, London

Discounted rate of £1,500 + VAT if booked with FDA APPROVAL PROCESS FOR MEDICAL DEVICES (N9-8110) on 27 September 2010

Introduction:

This course provides a comprehensive review of the FDA Combination Product process. The course provides approaches to the preparation and submission of documents to the Office of Combination Products. Delegates will receive essential guidance and information about the Combination Product process, submission preparation and the underlying scientific and regulatory principals involved.

Who Should Attend

This seminar is intended for Regulatory, Technical and Quality Personnel who require an understanding of the FDA Combination Products process. Management, Legal and other personnel who must be familiar with the essentials of the combination product approval process and submission of related documents will also benefit in attending.

Benefits in Attending:

• Know what combination products are
• Learn the structure and how to best navigate the Office of Combination Products
• Understand how to determine the primary mode of action
• Gain a comprehensive overview of the FDA combination product process
• Be in a position to prepare a request for designation submission

Speaker:

Albert A. Ghignone - FDA Regulatory, Quality & Clinical Consultants, AAG Incorporated, USA
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