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ADVERSE EVENT MANAGEMENT DURING MEDICAL DEVICE CLINICAL STUDIES
(Seminar)
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.
Event Website : ADVERSE EVENT MANAGEMENT DURING MEDICAL DEVICE CLINICAL STUDIES
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44 1483 730071
