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Mercure Paris La Défense Grande Arche

Nov 15, 2017 12:30 PM - Nov 16, 2017 4:30 PM

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

Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)

ONLY 1 SEAT LEFT! This course introduces essential aspects of medical writing of aggregate safety reports in the context of current legal framework in the EU and globally.

Agenda

Day 1 Nov 15, 2017

12:30 PM — 1:15 PM

REGISTRATION

1:15 PM — 1:30 PM

WELCOME AND INTRODUCTION OF FACULTY AND PARTICIPANTS

1:30 PM — 2:15 PM

INTRODUCTION TO THE PSUR/PBRER

2:15 PM — 3:00 PM

GENERAL PRINCIPLES AND STRUCTURE OF THE PSUR/PBRER

3:00 PM — 3:30 PM

COFFEE BREAK

3:30 PM — 4:00 PM

PLANNING PROCESS AND INTERDEPARTMENTAL RESPONSIBILITIES

4:00 PM — 5:00 PM

PSUR/PBRER PLANNING EXERCISE

5:00 PM — 6:00 PM

NETWORKING RECEPTION

Day 2 Nov 16, 2017

8:30 AM — 9:30 AM

WRITING OF THE PSUR/PBRER SECTION-BY-SECTION (PART 1) – INTRODUCTORY SECTIONS

9:30 AM — 10:15 AM

WRITING OF THE PSUR/PBRER SECTION-BY-SECTION (PART 2) – PRESENTATION OF FINGINDS

10:15 AM — 10:45 AM

COFFEE BREAK

10:45 AM — 12:00 PM

WRITING OF THE PSUR/PBRER SECTION-BY-SECTION (PART 3) – DATA EVALUATION

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:30 PM

WRITING OF THE PSUR/PBRER SECTION-BY-SECTION (PART 4) – BENEFIT-RISK ANALYSIS

1:30 PM — 2:00 PM

QUALITY CONTROL AND REVIEW (WITH A CASE STUDY)

2:00 PM — 2:30 PM

TEST

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:30 PM

EXERCISE IN MEDICAL WRITING OF CRITICAL PARTS

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Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)

Agenda

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