CRED 8 Presentations

01/07/2024

Global Regulatory Strategies – What, Why, When?

Access to new medicines is dependent on successful approval

Ensure the development plan is focused on product approval in a diverse regulatory environment with commercially viable labelling

Begin at the beginning...follow through

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

3

3

Elements of a Global Regulatory Strategy

Strategic input during stages of development • discovery and early development • Phase III and filing • registration and life-cycle Consider an alternative/modern approach:

• Breakthrough Designation/PRIME • Early dialogue/Innovative Pathways

Eichler, H. et al. 2015. From adaptive licensing to adaptive pathways: Delivering a flexible life ‐ span approach to bring new drugs to patients. Clinical Pharmacology & Therapeutics . (2015).

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

4

4