Module 3 Presentations

07/05/2024

Putting Dossier Development in Context

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

33

Integration of RA: Components of a Regulatory Strategy -> RA-CMC

• Understanding the product and its target markets

• Understanding data and information requirements for different types of applications in the target markets

• Establishing regulatory milestones and submission timelines

• Developing a plan for outreach to regulatory agencies and to other external stakeholders

• Developing a publication plan (scientific literature or other)

In the end it is about a scientific sound story telling and justifications in terms of safety and efficacy - a patient centric approach

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

34