Clinical Trial Regulations MasterClass - US edition

This Masterclass will take you through the key regulatory requirements for clinical research in the United States

15-16 November, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

Clinical trial conduct in the United States must follow the US Food and Drug Administration’s (FDA’s) regulations as published in the Code of Federal Regulations (CFR). Following the regulations demonstrates to the FDA the clinical research stakeholders’ commitment to participant safety, clinical trial quality, and data integrity.

This Masterclass will take you through the key regulatory requirements for clinical research in the United States including regulations on human subject protection, the informed consent process, investigational product (drug and medical device), Institutional Review Boards, clinical trial essential documents, roles and responsibilities of the sponsor and the investigator, safety management and reporting, and HIPAA requirements related to clinical trials.

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RECOMMENDATION

Who should attend?

• Anyone involved in clinical trials in the United States
• Clinical Research Professionals
• Sponsors
• CROs
• Clinical Sites
• CRAs, Project Managers
• Clinical Operations
• Principal Investigators
• Study Coordinators
• Study Managers