CRED ERP 25

02/07/2025

Timing of regulatory strategy

Target product profile (TPP) / label development

Ongoing regulatory input / interactions / intelligence

Discovery / candidate selection

Phase I-II / Early clinical development

Phase III / License application

Post-approval

Product grave

Regulatory accelerated mechanisms

Regulatory pathways for specific populations / therapeutic areas

Regulatory efficiency or support pilots / initiatives

GxP inspections, licences and compliance

The Organisation for Professionals in Regulatory Affairs

04/25/2022

Prepared by My Inner Voice for AstraZeneca & TOPRA

9

9

Corporate objectives

Formulating a global regulatory strategy

Target Product Profile (TPP)

Product exclusivity

Lifecycle management

Development plan

Scientific & technical data

Approval options

Elements of a Global Regulatory Strategy

Research!

•

• Cross-functional, multi-stakeholder input and discussion

Regulatory frameworks/ pathways

Patient engagement

• Governance and decision-making

Evolving, living document

•

Regulatory risk, mitigations and assumptions

Regulatory intelligence

Planned HTA interactions

Planned Agency interactions

The Organisation for Professionals in Regulatory Affairs

10

5