Adverse Event Management In Medical Device Studies
MEDV11 - October 25 2012
Who would benefit?
Those responsible for monitoring medical device studies, adverse event management and reporting. CRAs, regulatory staff and clinical investigators who conduct medical device clinical studies and would like to learn more about identifying, interpreting and reporting adverse events during the conduct of a device study.
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 occuring during a study.
Programme
This course provides an excellent overview of adverse event reporting issues and is suitable for those with some experience of conducting medical device studies. The day will include case studies of different types of adverse events.
- What are the regulatory requirements for monitoring and reporting adverse events during regulatory and post market studies.
- How to define and classify adverse events.
- How to design a data collection form for recording adverse events.
- How to obtain follow-up information from investigators.
Training course booking form
Microsoft Word .doc - Click here to download
Adobe Acrobat .pdf - Click here to download
The form contains the prices and terms & conditions. Please return the completed form either:
As an attachment e-mailed to enquiries@medvance.co.uk,
By fax: +44 (0)1757 270055
By post to: Medvance Ltd, Medvance House, Burn Grange, Doncaster Road, Burn, Selby, North Yorkshire, YO8 8LA, United Kingdom
(NB: Please note that .pdf can only be printed, and then faxed or posted, and not re-edited. Some users may need to right click on the above links and click 'Save target as...'. In order to open/view PDF documents you will need Adobe Reader software installed which can be obtained free from Adobe's Website (click here))
