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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