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

13

13

Internal and External Expertise

Existing products and therapeutic areas On-going development projects Competitor activity Investigators and academic experts Conferences, scientific societies and expert groups Regulatory consultants Regulatory agencies Health technology assessment Personalised medicine/diagnostic requirements

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

14

14