Module 6

02/10/2024

Disclaimer

• Most statements and views expressed herein are those of the presenters.

• The focus and perspective taken with this lecture (Part 1 and Part 2):

o Regulatory Perspective

o Majority EU focused with some US thoughts in mind

o Key strategic thinking and planning of the regulatory pathway not operational planning

o Does not cover emerging markets

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

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This Presentation will Cover

Post-Approval & Life Cycle Management

Development Program MAA Approval & Launch

Maintain and Extend the Brand - Part 2

Define and Shape the Brand - Part 1

Key Marketing Considerations and Constraints

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Integrated Development Plan

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Disease Area Strategy

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Value Proposition

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Target Product Profile and Product Claims

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Regulatory Pathway

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EU Regulatory Early Access Tools

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Product Name

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Key Collaboration and Communication Plans

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Product Launch Activities

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• Future Product / Brand Developments – PART 2 Maintaining and extending the brand

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

4

2