EMA Information Day on Risk Management Planning

Agenda

Day 1 Oct 25, 2018

8:00 AM — 8:45 AM

Registration

8:45 AM — 9:00 AM

Welcome Note

9:00 AM — 10:45 AM

GVP V REVISION 2: PRACTICAL APPROACH ON IMPLEMENTATION OF REVISED RMP TEMPLATE REV 2 GUIDANCE

10:45 AM — 11:15 AM

Coffee break

11:15 AM — 12:30 PM

SAFETY SPECIFICATIONS FOR BIOSIMILARS

1:30 PM — 3:00 PM

GVP GUIDELINES ON SPECIAL POPULATIONS

3:00 PM — 3:45 PM

Coffee Break

3:30 PM — 4:30 PM

RISK COMMUNICATION

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