Each conference participant selects one topic from the following list to discuss in an intimate setting. You’ll be asked for your topic preferences via email a week or so out from the conference and sign-up sheets for the remaining slots will be available onsite.
- WHAT MAKES A QUALITY CULTURE? Discuss the Cultural Tenets Needed to Embrace Transparency and Fuel a Quality-First Mindset
- GLOBAL QUALITY CULTURE: Share Experiences on Transforming Quality Culture in a Global Organization where Cultural Norms are Quite Different
- EFFECTIVENESS CHECKS: Manage Issue Resolution to Mitigate Risk by Preventing Future Occurrences
- CLINICAL DATA INTEGRITY: Share Common Data Integrity Challenges and Oversight Strategies to Mitigate Them
- STORYBOARDS: Understand How Companies are Using Storyboards to Document Oversight
- OVERSIGHT AT SMALL COMPANIES: Engage with Other Small Companies on How to Execute Effective Oversight with Limited Resources
- CHANGE MANAGEMENT: Share Best Practices for Handling and Managing Change without Impacting Clinical Quality Oversight
- OVERSIGHT RESPONSIBILITY AND DOCUMENTATION: Discuss Varying Approaches for Assigning who Owns, Manages and Documents the Oversight Process to Evaluate the Best Fit for Your Company
- QUALITY AGREEMENTS: Discuss the Utility of a Quality Agreement and How it Relates to Other Documentation
- MOCK INSPECTIONS: Evaluate Varying Approaches for Leveraging Mock Inspections as an Oversight Tool
- CLINICAL DATA GOVERNANCE: Recognize the Significant Expansion of Sponsor Responsibilities Related to Clinical Data Governance and Data Quality in ICH E6 (R3) and How this Impacts Oversight
- OVERSIGHT OF COMPUTERIZED SYSTEMS: Evaluate Access and Operational Best Practices for Ensuring Accurate Data is Entered Correctly and in a Timely Manner