7 December 2016 EMA/805050/2016 Deputy Executive Director

Agenda – Update on the implementation of EMA policy on publication of clinical data (Policy 0070) and revisions to the guidance to industry – Industry Associations Webinar 9 December 2016, 10:00 to 12:00 GMT

Chair: Noël Wathion, Deputy Executive Director, EMA Item

Topic

Name

Time

1.

Welcome and introduction (meeting logistics), including

N. Wathion

10 mins

an update on the implementation of EMA policy 0070 and background to the revision of the guidance to industry 3.

Details of changes to the guidance to industry

A-S. Henry-Eude

20 mins

4.

Discussion

All

40 mins

5.

Update on the letters to industry regarding the submission of the redaction proposal document package

6.

Next steps & close of meeting

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F. Nuttall/S. Howard N. Wathion

10 mins

10 mins

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