Module 1 2021

25/06/2021

Bringing a new product through various stages of product development is a mammoth task [1]… Receiving then a license is a big step forward … Work does not end with the grant of a license… …it‘s just the beginning of the Life Cycle of a medicinal product

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

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Overview Product Lifecycle & RA projects Integrated Drug Development?

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Seek SA?

Support Product Development

Submit PIP

Dossier Creation

Clinical Development Program (CTAs)

Successful completion of Phase 3

Seek SA?

Submission of MAA

Renewal

Grant of license

Questions & Answers from Assessors

* Patent Application

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

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