Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.

Agenda

Day 1 Dec 05, 2016

1:00 PM — 5:30 PM EU Clinical Trials Regulation: Anticipating the Changes

Day 2 Dec 06, 2016

8:30 AM — 9:00 AM REGISTRATION AND WELCOME COFFEE
9:20 AM — 9:30 AM WELCOME & INTRODUCTIONS
9:30 AM — 11:00 AM SESSION 1: CTREG IMPLEMENTATION STATUS IN MEMBER STATES
11:00 AM — 11:30 AM Coffee Break
11:30 AM — 12:30 PM SESSION 2:EXPERIENCES FROM PILOTS
12:45 PM — 1:45 PM Lunch
1:45 PM — 3:00 PM SESSION 3: TECHNICAL ISSUES
3:00 PM — 3:30 PM Coffee Break
3:30 PM — 4:45 PM SESSION 4: RISK-ADAPTED TRIALS/ LOW-INTERVENTIONAL TRIALS / OBSERVATIONAL TRIALS
4:45 PM — 5:45 PM SESSION 5: SAFETY REPORTING IN THE EU CLINICAL TRIAL REGULATION- AN UPDATE ON DEVELOPMENTS AND INTERACTIVE Q&A SESSION

Day 3 Dec 07, 2016

8:30 AM — 9:00 AM REGISTRATION AND WELCOME COFFEE
9:00 AM — 9:15 AM WELCOME & INTRODUCTIONS
9:15 AM — 10:30 AM SESSION 6: EU PORTAL & DATABASE
10:30 AM — 11:00 AM Coffee Break
11:00 AM — 12:00 PM SESSION 7: KEY ELEMENTS OF CT DATA TRANSPARENCY IN THE EU
12:00 PM — 1:15 PM Lunch
1:15 PM — 2:15 PM SESSION 8: EMA POLICIES 0070: FIRST EXPERIENCES AND IMPLICATIONS
2:15 PM — 3:15 PM SESSION 9: EMA Policy 0070: Challenges and Techniques for Sponsors
3:15 PM — 3:45 PM Coffee Break
3:45 PM — 5:00 PM SESSION 10: PROVISION OF RESULTS TO PATIENTS
5:00 PM — 6:00 PM Networking Reception

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