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Mercure Paris La Défense Grande Arche

Nov 28, 2017 8:00 AM - Nov 29, 2017 3:15 PM

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

Benefit-Risk Management

2ND OFFERING THIS YEAR DUE TO HIGH DEMAND! Our best-in-class instructors teach you the Do’s and Don’ts for BRM over the lifecycle of the product, and the course includes the Rev 2 of the GVP Modules V and XVI.

Agenda

Day 1 Nov 28, 2017

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

WELCOME AND INTRODUCTION OF FACULTY AND PARTICIPANTS

8:45 AM — 10:30 AM

INTRODUCTION TO BENEFIT-RISK MANAGEMENT

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 11:45 AM

INTRODUCTION TO BENEFIT-RISK METHODOLOGIES

11:45 AM — 12:15 PM

EXAMPLES OF APPLICATION OF BENEFIT-RISK METHODOLOGIES

12:15 PM — 1:15 PM

LUNCH

1:15 PM — 1:45 PM

DESIGNING RISK MANAGEMENT SYSTEMS

1:45 PM — 2:00 PM

DOS AND DON’TS IN SAFETY SPECIFICATION

2:00 PM — 2:45 PM

TOOLBOX FOR PHARMACOVIGILANCE PLANNING

2:45 PM — 3:15 PM

COFFEE BREAK

3:15 PM — 4:00 PM

EFFICACY SPECIFICATION AND FOLLOW-UP PLAN

4:00 PM — 5:00 PM

OPTIONS FOR RISK MINIMISATION

5:00 PM — 6:00 PM

NETWORKING RECEPTION

Day 2 Nov 29, 2017

8:20 AM — 9:45 AM

EVALUATION OF RISK MINIMISATION EFFECTIVENESS

9:45 AM — 10:15 AM

COFFEE BREAK

10:15 AM — 12:15 PM

BENEFIT-RISK MANAGEMENT PLAN – CASE STUDIES

12:15 PM — 1:15 PM

LUNCH

1:15 PM — 2:15 PM

BENEFIT OPTIMISATION

2:15 PM — 3:15 PM

USE OF BENEFIT-RISK MANAGEMENT PLANS IN REGULATORY SUBMISSIONS

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Benefit-Risk Management

Agenda

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