CRED 8 Presentations

01/07/2024

Agenda

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

15

15

Filing Strategy and Commercial Objectives

Understanding value • new therapeutic approach • therapeutic improvement or differentiation • time • commercially acceptable launch label • access & health technology assessment strategy • intellectual property and data exclusivity • synergy within your portfolio

Drivers for submission strategy

• economic drivers • development drivers • competitive environment • approval times • HTA strategy • diagnostic requirements • early market entry opportunities

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

16

16