Spring Intro 2023

30/03/2023

What is Regulatory Strategy ?

• Maps required regulatory activities to bring a product to market • Must at a minimum consider all mandatory regulatory requirements and should detail potential opportunities for regulatory intervention. • Defines associated timelines • Aligned with the company defined business strategy • Maximises chances of achieving the company desired goal for a product/portfolio

The Organisation for Professionals in Regulatory Affairs

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Overall Aim

To obtain the optimal license in as many countries as possible (in line with company objectives) ensuring patient access as quickly as possible. • Ensure successful regulatory approval of a product…with the optimum label • Ensure regulatory approval in as wide a geographical area as possible • Ensure best chance of patient access (appropriate clinical studies and endpoints to support reimbursement) • To do this as quickly as possible to ensure access to novel medicines

The Organisation for Professionals in Regulatory Affairs

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