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:
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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:
  • Overview of FDA requirements for clinical trials under an IND or IDE application.
  • Regulatory responsibilities of the clinical project manager
  • An ideal clinical trial protocol and processes to amend it
  • Addressing adverse events and safety reporting
  • Management of randomization, blinding, unblinding, and DSMB review
  • Managing investigational products: stability, storage, accountability, and expiry
  • IRB review and review of the IRB processes by sponsors
  • Recruitment strategies
  • What and what documents not to submit to FDA
  • When and how to seek regulatory clarification
  • Risk management: Key techniques in risk reduction, assessment, addressing, training and communication
  • Corrective and Preventive Actions (CAPA) for clinical trial projects
  • Do’s and don’ts of investigator meetings
  • Challenges of large-scale and international clinical trials 

Learning Objective: 

At the end of the seminar, the attendees will be familiar with the following:
  • Most common regulatory issues for clinical trial management
  • Documents required for FDA submission and trial master files
  • Processes to seek and document management decisions with regulatory implications
  • Do’s and Don’ts for regulatory management of a clinical trial 
Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • Clinical Project Managers
  • Clinical research associates
  • Clinical coordinators
  • Principal Investigators and sub investigators
  • IRB personnel.
  • Regulatory Vice Presidents, Directors and Managers
  • Attorneys – In-house or Outside Counsel
Date: August 2, 2023
Time: 12 PM EST
​Duration: 60 Minutes

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the webinar agenda and logistics, please call 410-501-5777 or email: info@fdamap.com