Conference Date: 28-29 Jan 2010
Conference Ref: N1-8310
Fee: £1180 + VAT
Venue: The Rembrandt Hotel, London
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
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