Medical Device Clinical Investigations and Evaluations
15th March - 16th March 2010 | UK
Category: Devices & Diagnostics
Address: The Rembrandt Hotel, 11 Thurloe Place, London, SW7, UK
Organiser: Management Forum
Website: CLICK HERE to open.BENEFITS IN ATTENDING
This course has been designed specifically for those involved in gathering clinical data to support regulatory approval and marketing of medical devices. With the recent amendments to the Medical Device Directives there are more stringent requirements to ensure the quality of the data submitted for CE marking of devices, and the data which needs to be generated once the device is on the market. In addition, the institutions that purchase products, the National Health Authorities throughout Europe and other countries are asking for cost effective and health economic data. There is increasing pressure on manufacturers to provide more clinical evidence and make sure that the evidence is both applicable and robust. This course will cover all of these issues and provide you with the tools you need to enable you to meet the requirements for clinical data.
The seminar will include interactive sessions and workshops to help you build your tool kit, and there will be plenty of time for case studies and group discussions. If you require any further information, please contact Andrea James on andrea.james@management-forum.co.uk
WHO SHOULD ATTEND
This course will be of interest to those who are involved in collating clinical data; this includes Regulatory and Clinical personnel conducting Literature Reviews/ Clinical Evaluations and Clinical Investigations. It will also be of use to staff working in Quality departments and Research and Development departments, particularly where you are involved in CE Marking and Post Market Surveillance. Personnel involved in setting up, managing and monitoring Medical Device Studies will also benefit from this seminar
TOPICS TO INCLUDE:
- Why Clinical Data is Required by Competent Authorities
- Clinical Investigation Notifications to Competent Authorities
- Notified Body Expectations
- How to Provide the Data
- Health Economics: Achieving Successful Reimbursement Studies for Medical Devices
- Collecting Post Market Surveillance Data
- Conducting a Clinical Evaluation / Literature Review
- Regulatory References and Background to Clinical Evaluation
- The Process for Determining the Need for Clinical Data
- How to Determine Which Route to Follow
- Conducting the Literature Review
- Getting Data Accepted for CE Marking
- Preparing the Clinical Evaluation Report
To be chaired by:
Janette Benaddi CEO of Medvance Limited
Speakers:
Suzanne Halliday Global Team Leader – Orthopaedic & Dental Devices, Healthcare Division of BSI Product Services
Professor Paul Trueman Professor of Health Economics, University of Brunel MHRA Representative (invited)
All Management Forum events count towards 5.5 CPD Points per day.
For more information on this event, please contact leigh@management-forum.co.uk or for a brochure, please visit:
