CRED ERP 25

02/07/2025

Integrating filing strategy with commercial objectives

Value proposition

Drivers for submission strategy

• New therapeutic approach • Therapeutic improvement / differentiation • Time • Commercially acceptable launch label • Market access strategy • Intellectual property and data exclusivity • Synergy within your portfolio • Enhancing company value and credibility

• Economic drivers • Development drivers • Competitive environment • Approval timelines • HTA strategy • Early market entry opportunities

The Organisation for Professionals in Regulatory Affairs

17

EU decreasing share of global clinical trials while China leads

Ref: https://efpia.eu/media/o2gjnmfu/efpia_ve_iqvia_assessing-the-clinical-trial-ct-ecosystem.pdf, Oct 2024

The Organisation for Professionals in Regulatory Affairs

18

9