Insights from Master Protocol Expert Meeting
Discover key takeaways and instructions from the Master Protocol Expert Meeting, including details on facilities, breakout sessions, and strategies for developing effective tools and scopes in regulatory agencies. Learn about the importance of fit-for-purpose tools, enterprise-level strategies, and successful execution methods discussed during the event.
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Presentation Transcript
October 23, 2019 Master Protocol Expert Meeting
Welcome Restrooms: Outside meeting room and to the left (down hallway next to the elevators) Parking: See staff at registration desk for vouchers Push to talk microphones Please turn phones on vibrate or silent Please use room Wi-Fi not personal hotspot Wi-Fi instructions: Connect to WESTIN-MEETING wireless network 1. Browser should atomically open- if it does not open, you will need to open a Google browser 2. Enter Password: CTTI2019 3. Browser may say application is not available - please ignore. You should be connected.
October 22, 2019 Breakout Session Instructions Kimberly Fisher, CTTI
What makes a good tool? Fit-for-purpose: Responsive to the objectives of a specific strategy Responds to the needs of a specific audience Actionable: Facilitates strategic action to address a well-identified problem Flexible: Can be updated over time Not overly prescriptive
Strategy Scope Changing Hearts and Minds Broad capacity building Enterprise- Level NUTS AND BOLTS: How do we get it done? Study- Level
Tool Scope TOOL: Forum for international regulatory agencies to discuss using master protocol studies in diverse therapeutic areas Enterprise- Level Study- Level TOOL: Regulator Communications Toolkit
Tool Outline 1. Purpose: 2. Audience: 3. Format: 4. Data needed: 5. Metrics of success:
Day 2 Breakout Sessions Yellow Group: Planning Blue Group: Pre-Planning Green Group: Execution Facilitator: Karen Dimick, Genentech CTTI Staff: Annemarie Forrest Room: Crystal II Facilitator: Gene Vinson, Syneos CTTI Staff: Kimberly Fisher Room: Crystal III Facilitator: Rajeshwari Sridhara, FDA CTTI Staff: Laura Shannon Room: Crystal IV
