Clinical Trial Regulations MasterClass - US edition
15-16 November, 2023
Clinical trial conduct in the United States must follow the FDA’s regulations as published in the CFR
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
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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Who should attend?
• Anyone involved in clinical trials in the United States
• Clinical Research Professionals
• Clinical Sites
• CRAs, Project Managers
• Clinical Operations
• Principal Investigators
• Study Coordinators
• Study Managers
"High attention to detail in course content and very well delivered"
Product Development Manager
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Manager, Senior Investigator
MT Sword Laboratories (BMS)
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