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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Clinical Trial Regulation Conference

Agenda

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