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Mercure Paris La Défense Grande Arche

Nov 14, 2017 8:00 AM - Nov 15, 2017 12:00 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre (Paris region), France

EU-RMP Creation

This course is sold out. Next EU-RMP Creation course takes place 26-27 February 2018 in Prague.

Agenda

Day 1 Nov 14, 2017

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

WELCOME AND INTRODUCTION OF FACULTY AND PARTICIPANTS

8:45 AM — 9:30 AM

INTRODUCTION TO BENEFIT-RISK MANAGEMENT

9:30 AM — 10:00 AM

OBJECTIVES AND STRUCTURE OF THE EU-RMP

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 11:00 AM

SOURCE DATA AND PLANNING PROCESS

11:00 AM — 12:00 PM

GROUP WORK - PROJECT MANAGEMENT

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:30 PM

CREATION OF THE EU-RMP – PRODUCT AND DISEASE/CONDITION OVERVIEWS

1:30 PM — 2:15 PM

CREATION OF THE EU-RMP – SAFETY SPECIFICATION MODULES SII-SVI

2:15 PM — 2:45 PM

COFFEE BREAK

2:45 PM — 3:45 PM

CREATION OF THE EU-RMP – IDENTIFIED/POTENTIAL RISKS AND SAFETY CONCERNS (MODULES SVII AND SVIII)

3:45 PM — 4:30 PM

CREATION OF THE EU-RMP – PHARMACOVIGILANCE PLAN AND POST-AUTHORISATION EFFICACY STUDIES

4:30 PM — 5:30 PM

NETWORKING RECEPTION

Day 2 Nov 15, 2017

8:00 AM — 9:00 AM

CREATION OF THE EU-RMP – RISK MINIMISATION PLAN

9:00 AM — 9:30 AM

CREATION OF THE EU-RMP - SUMMARY OF THE EU-RMP AND ANNEXES

9:30 AM — 10:00 AM

TEST

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

GROUP WORK – KEY PARTS OF EU RMP (WRITING EXERCISE)

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EU-RMP Creation

Agenda

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