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Session 8, Track A: Do You Have a Handle on Data Transparency? Best Practices for Management and Public Release of Clinical Data and Confidential Business Information
Session Chair(s)
Maria Anillo
Regulatory Affairs Project Manager
AstraZeneca Canada Inc., Canada
Brenda Gryfe, MSC
Regulatory Consultant
Brenda Gryfe Regulatory Consulting, Canada
Increased transparency requirements, with the need to protect personal information and confidential business information (CBI) have posed challenges. In this session, we will discuss obstacles faced by Sponsors to share best practices and key considerations for the public release of clinical data, which address feedback from Health Canada on data anonymization and redaction. We will also hear from an end user on use of data gathered from the platform.
Learning Objective : - Define transparency requirements for sponsors and expectations from regulators
- Describe challenges faced by Sponsors when dealing with data anonymization/redaction
- Discuss best practices and key considerations for public release of clinical data, during dossier preparation and post-approval
Speaker(s)
Public Release of Clinical Information Industry’s Experience and Challenges
Lama Abi Khaled, JD, MBA
Innovative Medicines Canada, Canada
Executive Director, Ethics, Legal and Regulatory
Best Practices in Protecting Personal and Confidential Business Information in Clinical Documents for Public Disclosure
Obaraboye Olude, MPH
Privacy Analytics, Inc., Canada
Clinical Trial Transparency Manager
Proactive and Reactive Strategies for Protecting Personal and Confidential Business Information in Clinical Documents for Public Disclosure
Honz Slipka
Certara, Canada
Sr. Transparency Specialist
Enhanced Information Access Supporting Decisional Transparency
Samantha Pollard, PHD, MS
BC Cancer, Canada
Senior Methodologist