Module 1 2021

25/06/2021

Target Product Profiles (“xTPPs”)

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The Organisation for Professionals in Regulatory Affairs

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Target Product Profile(s)

The TPP should begin with the goal in mind… It should be a dynamic summary which changes as knowledge of the product increases… ideally, the draft labeling submitted with a new application should be similar with the final version of the TPP…

… prepared by all functions involved in product development and lead by Project Management …

50

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

50

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