Clinical Trial Disclosure and Data Transparency Conference

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

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Session 4: Preparing for Results Submission Under Final Rule and Other Global Requirements - Panel Discussion

Session Chair(s)

Erik Lakes, MS, MSc

Senior Director and Head, Data Disclosure & Transparency

Beigene, United States

Are you prepared for submitting results under the new Final Rule requirements? How do the final regulations impact your company’s disclosure timelines? Are your protocols and SAPs ready for public disclosure? What actions do you need to take now to ensure compliance in 2018? This panel discussion will include perspectives from both industry and legal, and will include impact on other global requirements.

Learning Objective :
Describe Final Rule results requirements and impact on your company’s existing disclosure policy
Review different perspectives on how other sponsors are preparing for submissions
Prepare a checklist of action items in preparation of 2018 implementation

Speaker(s)

Panelist

René Allard, PhD

CTC, Germany

Contractor

Panelist

David Peloquin, JD

Ropes & Gray LLP, United States

Senior Advisor, MRCT Center; Associate, Health care Group

Panelist

Ramona L Rorig

Astellas Pharma Global Development, United States

Associate Director Clinical Trial Disclosure

Clinical Trial Disclosure and Data Transparency Conference

Session 4: Preparing for Results Submission Under Final Rule and Other Global Requirements - Panel Discussion

Session Chair(s)

Erik Lakes, MS, MSc

Learning Objective : Describe Final Rule results requirements and impact on your company’s existing disclosure policy Review different perspectives on how other sponsors are preparing for submissions Prepare a checklist of action items in preparation of 2018 implementation

Speaker(s)

Panelist

Panelist

Panelist

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Learning Objective :
Describe Final Rule results requirements and impact on your company’s existing disclosure policy
Review different perspectives on how other sponsors are preparing for submissions
Prepare a checklist of action items in preparation of 2018 implementation