ADVERSE EVENT
MANAGEMENT DURING
MEDICAL DEVICE
CLINICAL STUDIES

Conference Date: 08 Dec 2009-11 Feb 2010
Conference Ref: N12- 8009
Fee: £540 + VAT
Venue: The Rembrandt Hotel, London

BENEFIITS IN ATTENDING:

• Understand the Significance of the Revision of the MDD In Relation to Adverse Incident Reporting
• Gain an Overview of the Current System In Europe
• Keep Abreast with GHTF Progress
• Know the Role of the Data Safety Monitoring Board
• Understand the Definitions and Classification of Adverse Events
• Get an Insight into Competent Authorities Expectations
• Learn What Happens After CE Marking

COURSE OBJECTIVES

At the end of the course delegates will be able to:-

• Explain the regulations governing the monitoring and reporting of adverse events
• Produce an appropriate adverse event form for use during a study
• Define and classify adverse events occurring during a study
• Understand the changes in the regulations and how they impact onadverse event reporting

WHO SHOULD ATTEND

Those responsible for monitoring medical device clinical studies and those involved in adverse event management and reporting in house and in the field, including; clinical and regulatory staff.  Clinical Investigators and clinical site staff who conduct medical device clinical studies and would like to learn more about identifying, interpreting and reportingadverse events during the conduct of a device study.

With:
Janette Benaddi, Chief Executive Officer, Medvance Ltd.

To book your place, please click here.