19 September 2017 EMA/620344/2017

Agenda – Forum on bioequivalence inspections 5 October 2017 – Continental Hotel Budapest, 14:00-18:00, Budapest, Hungary

Chair: Olivier Le Blaye (ANSM) Co-Chair: Maria Bonafonte (EMA) Item

Preliminary draft agenda

Initials

Mins

1.

Welcome and practical information

Introduction

14:00-14:05

2.

Data integrity – early signal detection

Presentation

14:05-15:35

Presentation

15:35-16:05

- data patterns/trends in data - similar PK profiles - etc. 3.

Statistic applied to BE trials

Picture and coffee break

16:05-16:20

4.

eCRF and other electronic systems

Presentation

16:20-17:00

5.

Inspections of Ligand Binding Assays (in

Presentation

17:00-17:30

particular ELISAs) 6.

Q&A

Discussion

17.30-17.45

7.

AOB

Discussion

17.45-17.50

8.

End of Forum

17:50-18:00

For preparation of the Forum: please bring any useful inspection tools (excel, word etc based, on USB stick) with you, if you like to present and share them.

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