CRED ERP 25

02/07/2025

Developing your Global Filing Strategy

Ming Ewe Smarter Biotech Solutions

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Learning outcomes

• To describe key strategic considerations for the development of a successful global strategy.

• Provides context for European regulatory strategy

• To cover the general approach and “regulatory philosophy”.

Subsequent presentations will specifically focus on developing and finalising your European regulatory strategy

The Organisation for Professionals in Regulatory Affairs

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