ADVERSE EVENT
MANAGEMENT DURING
MEDICAL DEVICE
CLINICAL STUDIES IN
EUROPE

Conference Date: 27 Jan 2012
Conference Ref: N1-8212
Fee: £575 + VAT
Venue: The Cavendish Hotel, London

DISCOUNT OFFERED IF BOOKED WITH EC MEDICAL DEVICE VIGILANCE SYSTEM AND POST MARKETING SURVEILLANCE MEETING (N1-8112) ON 25 & 26 JANUARY. CLICK HERE FOR FURTHER INFO

KEY TOPICS TO INCLUDE:

• The Regulatory Requirements for Monitoring and Reporting Adverse Events During Regulatory and Post Market Studies
•  How to Define and Classify Adverse Events
•  Handling of Adverse Events During Clinical Investigations 
• How to Design A Data Collection Form for Recording Adverse Events 
• The Role Of The Data Safety Monitoring Board 
• The Role Of The Competent Authority (CA)

This seminar provides a comprehensive overview of adverse event reporting issues during medical device clinical trials across Europe and is suitable for those with some experience of conducting medical device studies. 

The seminar will include case studies of different types of adverse events, highlight the different approaches across Europe and provide practical advice on how to manage these.

Please click here  to contact  Andrea James if you have any queries.