Trial Master File and Inspection Readiness Conference
Training & Workshop Day
9:30 am - 10:00 am
Registration and Coffee
10:00 am - 1:30 pm
THE REALITIES OF INSPECTION READINESS (THE 20/80 RULE)
Dora Endreffy -
Director Data Privacy and Data Governance, Juvenescence and Chairperson, HSRAA,
HSRAA
Adriana Robinson - Senior Specialist, Global Trial Master File, BeiGene
In this workshop we will be looking at the crucial elements and rule that will support sustainable inspections readiness. The 20/80 rules states that approximately 80% of effects in any given situation results from 20% of causes. We will be discussing how different operations and elements of clinical trials, inspections and audits could be impacted when applying this rule.
Dora Endreffy
Director Data Privacy and Data Governance, Juvenescence and Chairperson, HSRAAHSRAA
1:30 pm - 2:30 pm
Networking Lunch
2:30 pm - 4:30 pm
A VOYAGE INTO THE GOLDILOCKS ZONE: SHIFTING EXPERIMENTAL DATA TO REAL WORLD DATA FOR NON-INTERVENTIONAL STUDIES
Stuart McCully, PhD -
Founder,
Phoenix-RWR Limited
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”
