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Holiday Inn London Kensington Forum

Feb 21, 2017 8:00 AM - Feb 22, 2017 12:00 PM

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

Post-Authorisation Studies

This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed.

Agenda

Day 1 Feb 21, 2017

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 9:00 AM

INTRODUCTION

9:00 AM — 10:00 AM

SESSION 1: INTRODUCTION TO PAS

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

SESSION 2: EU GUIDELINES/REGULATION – ONGOING CHANGE

12:00 PM — 1:00 PM

LUNCH BREAK

1:00 PM — 2:30 PM

SESSION 3: METHODOLOGY

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:30 PM

SESSION 4: PAS WORKSHOP I

4:30 PM — 5:30 PM

NETWORKING RECEPTION

Day 2 Feb 22, 2017

8:30 AM — 10:00 AM

SESSION 5: NON-EU GVP GUIDELINES, GVP RELEVANT GUIDANCES, DATA SOURCES ETC.

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

SESSION 6: PAS WORKSHOP II

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Post-Authorisation Studies

Agenda

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