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

7

7

Influencing Factors

Patients & medical need

Product type

Strength of data

Internal & external initiatives

• Development programme is focussed on achievement of the target profile • Adapting to the results of your development programme • Understanding weaknesses in your data • Impact of competitors or regulatory decisions

• Demographics • Disease prevalence • Seriousness & severity • Differentiation • Precedent

•New Chemical Entities • Line Extensions • Biologics • Generics • Orphan Products • Advanced Therapeutics • Therapeutic Area • Devices and Diagnostics • Integrated Solutions

• Company Portfolio • Interactions with

Regulatory Authorities

• Emerging

Regulatory Environment • Market Access Strategies

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

8

8