CRED 8 Presentations

01/07/2024

Labelling Drives Development and Supports Promotion

Differentiation must be reflected in the label • therapeutic • commercial • regulatory Strategies for success • target profile • label development • regulatory intelligence • define what is essential or negotiable

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

5

5

Target Product Profile

Global Submission Strategy

Regulatory Pathways

Supporting Documentation

Scientific & Technical Data

Elements of a Regulatory Strategy

Market Exclusivity

Regulatory Risks and Mitigations

Patient Engagement

Approval Options

Scientific Advice and Regulatory Interactions

Development Plan

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

6

6