In recent years, drug development has evolved to increasingly include the use of real-world data/evidence generated from non-interventional studies to support marketing authorisation applications and label extensions. 

In this workshop we’ll:

·       Explore the role of non-interventional studies in drug development

·       Highlight the applicable regulatory frameworks, resulting documentation and retention requirements

·       Introduce (and demonstrate) the TMF Reference Model designed specifically for non-interventional studies

·       Listen to your pain points and suggest practical and actionable solutions

Gain Practical Insight with Two Activities:

• Inspection Readiness Day: Brief exercise for trial teams!

• Quality Compliance Assessment: Mimic internal audits with a clear focus!

Session Objectives:

• Define the major topics for inspection readiness

• Understand the meaning of inspection readiness for your daily work

• Design strategies to ensure inspection readiness for individuals, departments and the whole company

Key take-homes:

• Understand how to plan and conduct inspection readiness activities

• Enforce lasting improvements by effectively implanting lessons learned

• Discover the importance of “Do it right the first time”