Module 6

04/10/2024

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WHO are the Consumers? • ..can consumers effectively self-medicate for the indication?

● Safety, in-use studies ● Safety, in special populations ● Safety ❑ Current clinical issues ❑ Back-switches

● User testing ● Branding issues ❑ Avoid confusion

The Organisation for Professionals in Regulatory Affairs

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Internal STRATEGIC issues to decide in advance …. • In addition to your USP… ● Other Potential ISSUES? ❑ Manufacturing practicalities ❑ Safety – history – PSURs / PRAC recommendations ❑ Safety - in use?

• Key information for the consumer? ● The leaflet / labelling ● Advertising and promotion

The Organisation for Professionals in Regulatory Affairs

84

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