Webinars >>Clinical Trials
Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, even other personnel involved in the conduct of a given trial. Starting from the filing of an IND or IDE application, numerous documents need to be collected to demonstrate compliance with regulations; many of these need to be submitted to FDA and IRBs at predefined times for review, comments and approval; and all are required for FDA audits. Frequently events such as protocol deviations and violations, subject and site management issues, and investigational product handling issues could require clinical project managers to seek clarification on the regulatory implications of the said event and appropriate actions. Clinical Project Managers need to have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial data, and even other more severe penalties.
Why should you attend:
This course will provide an overview of regulatory management for clinical trials. We would discuss the key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements. Practical tips for regulatory management of a clinical trial project will be provided using case studies from the presenter’s personal experience. If you are aspiring to be a clinical project manager, are sponsoring a clinical trial, supervise clinical trial operations, or would like to become a clinical site, this course is a must for you.
Areas Covered in the Session:
At the end of the seminar, the attendees will be familiar with the following:
Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:
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