Module 6

02/10/2024

Module 6: To Better Equip You Focused Key Topics to Assist with your Regulatory Strategy

DEFINING THE PRODUCT AND ITS PLACE ON THE MARKET • Developing the Brand and Shaping its Market Place.

LEGAL FRAMEWORK: PROTECTING THE BRAND • Protecting the Brand: Intellectual Property and Data Exclusivity

SUCCESSFULLY LAUNCHING THE PRODUCT ON THE MARKET • Demonstrating Value and Market Access • Pharmacovigilance and Risk Management • Health Authority Engagement and Assessment COMMUNICATING WITH THE MARKET • Advertising and Controls on Prescription Only Medicines • Issue Management • Communicating with Patients and Prescribers

EXTENDING THE LIFECYCLE OF THE PRODUCT • Extend and maintain the brand • OTC Switching

The Organisation for Professionals in Regulatory Affairs

Module 6: Welcome and Introduction

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Student / Delegate Participation

Interactive;

• Ask questions to further understand the subject;

• Speakers will naturally pause to check for questions;

• Attendees online - Use the chat functionality to ask a question;

• Teamwork during case studies;

• A platform to further your knowledge

Enjoy the module ☺

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The Organisation for Professionals in Regulatory Affairs

Module 6: Welcome and Introduction

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