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DoubleTree Bethesdan

2019 年 09 月 19 日 7:00 上午 - 2019 年 09 月 20 日 3:15 下午

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, BSN, DDS

Session Chair Invited, BSN, DDS

Manager, DIA, Switzerland

Poster Presentations and Networking Reception

Speaker(s)

Michelle  Hellstern, BSN

Michelle Hellstern, BSN

Manager, Clinical Trial Disclosure & Transparency, CSL Behring, United States

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

Raina  Agarwal, MPHARM

Raina Agarwal, MPHARM

Senior Manager, Kinapse Ltd, A Syneos Health Company, United States

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

Cathal  Gallagher

Cathal Gallagher

Associate Director Clinical Transparency & Trial Disclosure, Regeneron, United Kingdom

Do You Know Your Risk?

Lucy  Mosquera, MSC

Lucy Mosquera, MSC

Senior Director, Data Science, Replica Analytics, Canada

Experiences Generating Synthetic Clinical Trial Data

Veera  Thota

Veera Thota

, MMS Holdings, United States

Automating Data Anonymization Procedures with Software

Pooja  Phogat, PHD

Pooja Phogat, PHD

Founder and Co-CEO, Krystelis Ltd., India

Actionable Insights for Plain Language Summary Implementation

Nirpal  Virdee, MSC

Nirpal Virdee, MSC

Head, Transparency & Disclosure, Certara, United Kingdom

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

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