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  • FDA offers webinar series on ClinicalTrials.gov

FDA offers webinar series on ClinicalTrials.gov

ClinicalTrials.gov website screenshot

The FDA has provided a three-part webinar series on ClinicalTrials.gov: a general overview and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements.

Participants will gain an understanding of CDER's role and responsibilities with respect to ClinicalTrials.gov oversight and will hear examples of compliance and enforcement activities CDER has taken to encourage compliance.

Intended Audience

  • Sponsors, sponsor-investigators and clinical investigators designated as responsible for submitting registration and results information to ClinicalTrials.gov

Topics Covered

  • FDA's roles and responsibilities with respect to ClinicalTrials.gov oversight
  • An overview of ClinicalTrials.gov definitions, laws, and regulations
  • An overview of CDER's compliance and enforcement activities with respect to ClinicalTrials.gov requirements, including case examples

FDA Resources

  • FDA's Role: ClinicalTrials.gov Information

Webinars

Topics & Presentations

Speakers

ClinicalTrials.gov: Part 1

Meeting Transparency and Reporting Requirements

Miah Jung, Pharm.D.
Supervisory Pharmacologist
Division of Enforcement and Postmarketing Safety (DEPS) | Office of Scientific Investigations (OSI) | Office of Compliance (OC) | Center for Drug Evaluation and Research (CDER) | FDA

ClinicalTrials.gov: Part 2

Definitions, Laws, and Regulations

Jan Hewett, J.D.
Regulatory Counsel
Policy Office (PO) | OSI | OC | CDER | FDA

ClinicalTrials.gov: Part 3

CDER's Compliance and Enforcement Activities

Rachelle Swann, Pharm.D.
Lead Pharmacologist
DEPS | OSI | OC | CDER | FDA

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