Global Clinical Trial Disclosure and Data Transparency Conference

Session Chair Invited

Manager

Redaction Impact and Efficiencies Assessed for Optimal Transparency Preparation for the EU Clinical Trial Regulation 536/2014

Michelle Hellstern, BSN

CSL Behring, United States

Manager, Clinical Trial Disclosure & Transparency

Assessment of Anonymization Methods, Processes, and Challenges for Clinical Information Submissions to Health Canada

Raina Agarwal, MPharm

Kinapse Ltd, A Syneos Health Company, United States

Senior Manager

Do You Know Your Risk?

Cathal Gallagher

Regeneron, United Kingdom

Associate Director Clinical Transparency & Trial Disclosure

Experiences Generating Synthetic Clinical Trial Data

Lucy Mosquera, MSc

Replica Analytics, Canada

Senior Director, Data Science

Automating Data Anonymization Procedures with Software

Veera Thota

MMS Holdings, United States

Actionable Insights for Plain Language Summary Implementation

Pooja Phogat, PhD

Krystelis Ltd., India

Founder and Co-CEO

The Future of Transparency: How Global Regulatory Authorities May Expect Patient and HCP Engagement During the Drug Approval Process

Nirpal Virdee, MSc

Certara, United Kingdom

Head, Transparency & Disclosure