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

Event Website : MEDICAL DEVICE CLINICAL STUDIES - Understand How to Conduct Pre and Post Market

Location:	The Rembrandt Hotel, London
Contact:	Leigh White info@management-forum.co.uk 44 1483 730071
Organization:	Management Forum Ltd
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