Module 1 2021

25/06/2021

The Emerging Markets Regulatory Challenge

Across a wide number of countries and internal/external systems:

Drive consistency of approach (efficiency/compliance) While Building and executing strategy for key business drivers

BROAD range of reqts/systems across many 50-100 countries

DEEPENING technical, clinical, regulatory expertise in key countries

The Organisation for Professionals in Regulatory Affairs

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Challenges at Agency Level

• Building capability • Access to more info than ever before • Resources / Capacity building varied • Govt, society, industry pressure • Flexible: good & bad • Reliance on others • Focus on initial approval – life cycle capabilities developing

The Organisation for Professionals in Regulatory Affairs

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