EMA Information Day on Risk Management Planning – Implementation of GVP V and RMP Template Rev 2 Guidance

REGISTER EARLY! This Information Day is aimed at providing MAHs and MAAs with practical advice on RMP drafting using the principles of risk assessment and management included in GVP V Rev 2.

Agenda

Día 1 19 dic 2017

8:00 AM — 9:00 AM

Registration

9:00 AM — 9:15 AM

Welcome Note

9:15 AM — 10:30 AM

RISK MANAGEMENT PLANNING IN THE EU: DESIGNING FIT FOR PURPOSE RISK MANAGEMENT PLANS – GVP V AND RMP TEMPLATE REV 2 GUIDANCE

10:30 AM — 11:00 AM

Coffee break

11:00 AM — 12:45 PM

CHALLENGES IN IMPLEMENTING THE UPDATED RMP GUIDANCE – STAKEHOLDERS’ PERSPECTIVE

12:45 PM — 1:30 PM

Sandwich lunch

1:30 PM — 3:00 PM

THE EU RISK MANAGEMENT SYSTEM: STAKEHOLDERS INTERACTION – AREAS OF FUTURE FOCUS

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EMA Information Day on Risk Management Planning – Implementation of GVP V and RMP Template Rev 2 Guidance

Agenda

Be informed and stay engaged.