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Enhanced Approach and ICH Q14

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Posts: 37
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(@event-participant)
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Joined: 6 months ago

Are there specific parts of the enhanced approach that the panelists would recommend provide the most added value?


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Posts: 29
(@quality-experts)
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Joined: 6 months ago

The cornerstone of the whole approach is the ATP. If priority has to be given to a "part", then definitely the ATP. The ATP alone is not enough for the enhanced approach, though.

 

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