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Holiday Inn London Kensington Forum

Nov 29, 2018 12:30 PM - Nov 30, 2018 4:30 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

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

NEW OFFERING! 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 29, 2018

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

PSUR/PBRER PLANNING EXERCISE

4:00 PM — 5:00 PM

PLANNING PROCESS AND INTERDEPARTMENTAL RESPONSIBILITIES

5:00 PM — 6:00 PM

NETWORKING RECEPTION

Day 2 Nov 30, 2018

8:30 AM — 9:30 AM

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

9:30 AM — 10:15 AM

PSUR/PBRER SECTION-BY-SECTION (PART 2) – PRESENTATION OF FINDINGS

10:15 AM — 10:45 AM

COFFEE BREAK

10:45 AM — 12:00 PM

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

12:00 PM — 1:00 PM

LUNCH

1:00 PM — 1:30 PM

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

1:30 PM — 2:00 PM

QUALITY CONTROL AND REVIEW

2:00 PM — 2:30 PM

EXERCISE

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:30 PM

MEDICAL WRITING EXERCISE

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

Agenda

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