Spring Intro 2023

30/03/2023

How do I Develop a Regulatory Strategy ?

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Good Regulatory Strategies are based on Research

Take into consideration the bigger picture and determine probability of regulatory success

• Consider precedents during drug development • Analysis of key competitor decisions (FDA SBA, EMA EPAR, etc) • Consider key elements of clinical trials : • Single-arm studies • Real-world evidence/natural history studies • Uncommon/novel primary endpoints • Limited safety database for rare diseases • Lack of animal model during nonclinical development • Post-approval study requirements • Recommend and prepare for regulatory meetings with HAs

The Organisation for Professionals in Regulatory Affairs

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