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DIA, Europe, Middle East, and Africa

Jul 02, 2018 8:00 AM - Jul 03, 2018 3:30 PM

Kuechengasse 16, 4051 Basel, Switzerland

Benefit-Risk Management

Course venue: DIA, Europe, Middle East, and Africa office, Kuechengasse 16, 4051 Basel

Agenda

Day 1 Jul 02, 2018

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

WELCOME AND INTRODUCTION

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 Jul 03, 2018

8:30 AM — 10:00 AM

EVALUATION OF RISK MINIMISATION EFFECTIVENESS

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:30 PM

BENEFIT-RISK MANAGEMENT PLAN - CASE STUDIES

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 2:30 PM

BENEFIT OPTIMISATION

2:30 PM — 3:30 PM

USE OF BENEFIT-RISK MANAGEMENT PLANS IN REGULATORY SUBMISSIONS

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Benefit-Risk Management

Agenda

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