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Hotel Grand Majestic Plaza

Feb 26, 2018 8:00 AM - Feb 27, 2018 12:15 PM

Truhlarska 16, 110 00 Prague 1, Czech Republic

EU-RMP Creation

The participants will learn the best practice in medical writing of the EU-RMP. The solutions will be demonstrated in practical exercises included throughout the course.

Agenda

Day 1 Feb 26, 2018

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

WELCOME AND INTRODUCTION OF FACULTY AND PARTICIPANTS

8:45 AM — 9:15 AM

INTRODUCTION TO BENEFIT-RISK MANAGEMENT

9:15 AM — 10:00 AM

OBJECTIVES AND STRUCTURE OF THE EU-RMP

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 11:15 AM

GROUP WORK - PROJECT MANAGEMENT

11:15 AM — 12:00 PM

SOURCE DATA AND PLANNING PROCESS

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:30 PM

PRODUCT AND DISEASE/CONDITION OVERVIEW

1:30 PM — 2:15 PM

SAFETY SPECIFICATION MODULES SII-SVI

2:15 PM — 2:45 PM

COFFEE BREAK

2:45 PM — 4:15 PM

IDENTIFIED/POTENTIAL RISKS AND SAFETY CONCERNS (MODULES SVII AND SVIII)

4:15 PM — 4:45 PM

PHARMACOVIGILANCE PLAN AND POST-AUTHORISATION EFFICACY STUDIES

4:45 PM — 5:45 PM

NETWORKING RECEPTION

Day 2 Feb 27, 2018

8:00 AM — 8:45 AM

RISK MINIMISATION PLAN

8:45 AM — 9:30 AM

SUMMARY OF THE EU-RMP AND ANNEXES

9:30 AM — 10:00 AM

EXERCISE ON IDENTIFICATION OF SAFETY CONCERNS

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

GROUP WORK - WRITING EXERCISE

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EU-RMP Creation

Agenda

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