Module 1 2021

25/06/2021

Submission Planning (RA projects) Some considerations

 During licensing procedures o Prepare back up plans ( +gap analysis) o Drive preparation of responses (incl. strategy) o Organise meetings/ TCs with assessors o Be prepared for Oral Explanations o Last minute labeling negotiations & commitments (post approval)

… all to support the development/ maintenance of safe & effective medicinal products

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

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… is a temporary endeavour with a definite beginning & end … creates a unique product, service, or result [9] A Project …

Meet Regulatory, Legal, or Social Requirements

Satisfy Stakeholder Requests or Needs

Project

Create, Improve, or Fix Products, Processes or Services

Implement or Change Business or Technological Strategies

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

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