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

17

17

Final Remarks

Drug development is an increasingly complex activity

Approval times are converging with greater interdependence of the outcomes

HTA interactions should be integrated into development

Significant resources need to be applied effectively by applicant and regulators

Labelling drives development, the data should drive the labelling and the label supports access

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

18

18