Module 6

02/10/2024

Key Marketing Constraints Throughout development stages

A stringent pre-launch environment.

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• Competitor awareness and intelligence on market share. • Uncertainties of the final indication and product claims. • Uncertainties of the product positioning in the market place. • Cannot promote a product or brand name prior to licence approval. • Cannot always make links to the drug tradename. • Can only make assumptions of expected data results • Can only make certain product claims if supported by data • Timing of publication of key clinical data. • Timing of the licence approval (dependent on filing strategy and other regulatory constraints) • Timing to achieve pricing and reimbursement in certain countries. • Timing of supply of medicinal product ready for launch

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

7

Integrated Development Plan Define and shape the brand

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

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