MEDICAL DEVICE
CLINICAL STUDIES

Conference Date: 14-15 May 2009
Conference Ref: N5-8209
Fee: £1100 + VAT
Venue: Harrington Hall Hotel, London

PLEASE NOTE THERE HAS BEEN A CHANGE OF VENUE ~ THIS MEETING IS NOW BEING HELD AT THE HARRINGTON HALL HOTEL, 5-25 HARRINGTON GARDENS, LONDON, SW7 4BJ

Benefits in attending:

• Understand the affect of regulatory requirements on medical device clinical studies
• Clarify what is involved in a Clinical Evaluation (Literature Review)
• Discover how to design pre market and post market studies
• Know what documentation is needed and what should go in a study master file
• Discover how to obtain Research Ethics approval in each European Country
• Plan how to prepare regulatory notifications to the Competent Authorities
• Understand the key aspects of pre and post market study setup, management, monitoring and close down
• Take away practical tools on how to write a final study report for a regulatory clinical investigation pre market study
• Discuss how to prepare a paper or presentation for publication and marketing