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DoubleTree Bethesdan

19 sep 2019 7:00 a.m. - 20 sep 2019 3:15 p.m.

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

Poster Presentations and Networking Reception

Session Chair(s)

Session Chair  Invited

Session Chair Invited

Manager

DIA, United States

Poster Presentations and Networking Reception

Speaker(s)

Michelle  Hellstern, BSN

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

Raina  Agarwal, MPharm

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

Cathal  Gallagher

Do You Know Your Risk?

Cathal Gallagher

Regeneron, United Kingdom

Associate Director Clinical Transparency & Trial Disclosure

Lucy  Mosquera, MSc

Experiences Generating Synthetic Clinical Trial Data

Lucy Mosquera, MSc

Replica Analytics, Canada

Senior Director, Data Science

Veera  Thota

Automating Data Anonymization Procedures with Software

Veera Thota

MMS Holdings, United States

Pooja  Phogat, PhD

Actionable Insights for Plain Language Summary Implementation

Pooja Phogat, PhD

Krystelis Ltd., India

Founder and Co-CEO

Nirpal  Virdee, MSc

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

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