Module 1 2021

28-6-2021

What is a Regulatory Strategy?

• Regulatory Strategy: • Plan for developing the product with the goal of obtaining initial regulatory approval in desired markets • Plan also for lifecycle management including post approval maintenance

The Organisation for Professionals in Regulatory Affairs

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Why a Regulatory Strategy?

• For alignment of development, commercial and regulatory goals: • Development: CMC, non-clinical and clinical development plan • Commercial: key product label attributes and positioning, pharmacovigilance and “fourth hurdle” • Regulatory: scientific advice, procedure, legal basis, exclusivity

The Organisation for Professionals in Regulatory Affairs

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