Post-Authorisation Studies (PAS)

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.

会议日程

天 1 2016 年 06 月 13 日

8:00 AM — 8:30 AM

REGISTRATION

8:30 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: DETAILS ON EU GUIDELINES

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: CONCERNS OF THE AUDIENCE AND STUDY REVIEW

4:30 PM — 5:30 PM

NETWORKING RECEPTION

天 2 2016 年 06 月 14 日

8:30 AM — 10:00 AM

SESSION 5: NON-GVP GUIDELINES

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 12:00 PM

SESSION 6: PASS PREPARATION

Post-Authorisation Studies (PAS)

会议日程

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