Course 3 Global Regulatory Strategy

OBJECTIVE

Prepare a regulatory file for a new health product to ensure its commercialization

CONTENTS

• The components of a regulatory strategy
• Innovation opportunities in an international regulatory environment,
• Converging synergies
• The relevance and pitfalls of a global approach
• Multiplicity of regulations
• The international context
• The leverage of a global regulatory strategy
• Regulatory leadership,
• Information sources and regulatory intelligence,
• The emergence of AI in regulatory affairs
• Legal status and registration procedures
• Analysis of a frontier product (solar, blenching products etc.)

BENEFITS

At the end of this course, participants will be able to :

• Apply what they have learned in theory to the regulatory filing of an international application.
• Ask the right questions at the start of a project and understand the objective
• Organize and structure ideas
• Plan milestones and use support materials
• Define key milestones
• Communicate/present internally and externally
• Assess risks and identify ways of managing them
• Working in a group