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Session 4: Enforcement Initiatives by FDA and a UK Research Funding Agency
Session Chair(s)
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
Sponsors are required to register and report results of clinical trials according to regional laws and regulations. This session will focus on the enforcement initiatives by health authorities to ensure that sponsors are complying with clinical trial data disclosure requirements, while also highlighting the legal consequences of non-compliance. Note: Rachel Knowles will be participating virtually
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the initiatives health authorities are taking to encourage compliance
- Understand the potential civil and monetary penalties for non-compliance
Speaker(s)
Representative Invited
Deputy Director, Office of Scientific Investigations, Office of Compliance, FDA, United States
ClinicalTrials.gov: Meeting FDA Registration and Reporting Requirements
Rachel Knowles
Lead for Clinical Research Policy, Ethics and Government, Medical Research Council, United Kingdom
Compliance with Funder Requirements for Clinical Trials Transparency