Agenda
1:00 PM — 5:30 PM
EU Clinical Trials Regulation: Anticipating the Changes8:30 AM — 9:00 AM
9:20 AM — 9:30 AM
9:30 AM — 11:00 AM
SESSION 1: CTREG IMPLEMENTATION STATUS IN MEMBER STATES11:00 AM — 11:30 AM
11:30 AM — 12:30 PM
SESSION 2:EXPERIENCES FROM PILOTS12:45 PM — 1:45 PM
1:45 PM — 3:00 PM
SESSION 3: TECHNICAL ISSUES3:00 PM — 3:30 PM
8:30 AM — 9:00 AM
9:00 AM — 9:15 AM
WELCOME & INTRODUCTIONS9:15 AM — 10:30 AM
SESSION 6: EU PORTAL & DATABASE10:30 AM — 11:00 AM
11:00 AM — 12:00 PM
SESSION 7: KEY ELEMENTS OF CT DATA TRANSPARENCY IN THE EU12:00 PM — 1:15 PM
1:15 PM — 2:15 PM
SESSION 8: EMA POLICIES 0070: FIRST EXPERIENCES AND IMPLICATIONS2:15 PM — 3:15 PM
SESSION 9: EMA Policy 0070: Challenges and Techniques for Sponsors3:15 PM — 3:45 PM
3:45 PM — 5:00 PM
SESSION 10: PROVISION OF RESULTS TO PATIENTS5:00 PM — 6:00 PM
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