CRED 8 Presentations

01/07/2024

Developing Your Global Filing Strategy

Bob Clay Consultant, Highbury Regulatory Science Limited bob@bobclay.eu

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

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Agenda – Developing Your Regulatory Strategy

Regulatory strategy – what, why, when?

Influencing factors, e.g. product type, strength of data, internal & external initiatives

Scientific advice – where and how to obtain it

Utilising internal and external expertise

Integrating filing strategy with commercial objectives

Final remarks

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

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