Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials
Date: June 4, 2025
Duration: 60 Minutes
Time: 12 PM EST
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.
- 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
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
We accept credit card, debit card, and PayPal.
Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
