Module 6

02/10/2024

Learning Outcomes

• Key considerations in maintaining and extending brand awareness

• The input of the regulatory representative in shaping a successful product through to life-cycle management

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

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Maintaining and Extending the Brand Several elements during life-cycle management

MAA approval

Lifecycle Strategy

Benefit / Risk Assessment

Efficacy

Safety

PIP & ODD maintenance

New Indications

Minimizing risks

Maximizing Patients

Label enhancements

PAMs

PASS

PAES

Quality

Essential compliance activities: ▪ PSMF ▪ Marketing status reports ▪ GxP Inspections

New formulations

New dosage strengths

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

48

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