How to Make Efficient FDA-Compliant Clinical Protocol Amendments
Date: March 24, 2025
Duration: 60 Minutes
Time: 12 PM EST
This webinar, presented by a leading clinical protocol expert will discuss FDA expectations from protocol amendment process, and best practices for avoiding errors and accidents. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for clinical project teams using case studies and examples from the presenter’s vast experience helping large and small clinical trials in dealing with deviations, safety issues, and operational limitations that lead to protocol amendment. The webinar will provide tips for deciding when an amendment is necessary, the best practices for creating and implementing a protocol amendment without disrupting the study. Amendment to conventional, adaptive design, compassionate-use, and investigator-led clinical studies will be discussed with suggestions from a FDA-acceptance perspective. The seminar is designed to provide a well-rounded training to all stakeholders in all aspects of the creating and implementation of clinical protocol amendment.
- Five common reasons for amending a clinical protocol
- When a protocol should not be amended
- FDA expectations from protocol amendment process
- Operational aspects of protocol amendment
- Statistical issues that must be considered when amending protocols
- Differences between protocols for drugs, biologics and medical devices
- Best practices for training and monitoring clinical sites during and after protocol amendment
- Common FDA audit findings for improperly amended protocols and potential solutions
- Clinical research associates
- Clinical project managers
- Medical writers
- Sponsors
- Regulatory affairs personnel
- Quality assurance personnel
- Vice presidents, Directors and Managers
- People interested in investing in the FDA-regulated industry
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
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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.
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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.
