Agenda
8:00 AM — 8:45 AM
8:45 AM — 9:15 AM
WELCOME, INTRODUCTION AND OUTLINE OF THE COURSE PROGRAMME10:00 AM — 10:30 AM
10:30 AM — 11:15 AM
SESSION 2: HEADLINES OF THE EU REGULATORY SYSTEM FOR MEDICAL DEVICES11:15 AM — 12:00 PM
SESSION 3: RISK CLASSIFICATION (INCLUDING AN EXERCISE)12:00 PM — 12:30 PM
SESSION 4: PRE-MARKETING: ESSENTIAL REQUIREMENTS12:30 PM — 1:30 PM
2:15 PM — 3:00 PM
SESSION 6: POSITION, ROLE AND RESPONSIBILITIES OF NOTIFIED BODIES3:00 PM — 3:30 PM
3:30 PM — 4:15 PM
SESSION 7: QUALITY MANAGEMENT4:15 PM — 4:45 PM
SESSION 8: ECONOMIC OPERATOR OBLIGATIONS4:45 PM — 5:30 PM
9:00 AM — 9:45 AM
SESSION 9: THE BASICS OF RISK MANAGEMENT IN THE DEVELOPMENT10:30 AM — 11:00 AM
11:00 AM — 11:45 AM
SESSION 11: POST-MARKETING SURVEILLANCE MEDICAL DEVICES11:45 AM — 12:30 PM
SESSION 12: INTRODUCTION TO CLINICAL EVALUATION AND CLINICAL12:30 PM — 1:30 PM
1:30 PM — 2:00 PM
SESSION 13: HIGHLIGHTS OF THE NEW MEDICAL DEVICE REGULATION2:45 PM — 3:15 PM
4:45 PM — 5:00 PM
5:00 PM — 6:00 PM
9:45 AM — 10:30 AM
SESSION 18: APPLICABLE REGULATIONS AND QUALITY STANDARDS10:30 AM — 11:00 AM
11:45 AM — 12:30 PM
SESSION 20: EXERCISE ON HOW TO GET TO MARKET12:30 PM — 1:30 PM
3:00 PM — 3:30 PM
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Ways to register
Registration fee includes refreshment breaks, lunches and training course material.
This course has limited capacity. Register early!