10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development
Date: July 16, 2025
Duration: 60 Minutes
Time: 12 PM EST
At the end of this webinar, you would understand:
- Key element of a clinical protocol (scientific rationale, design, endpoints, etc.)
- Creating protocol team and SOPs
- Using templates and other tools
- Best practices for writing different components of the clinical protocol
- Ways to assure stakeholder involvement
- Practical issues with protocol writing and potential solutions
- Strategies for the protocol review, using key opinion leaders
- Ways to assure FDA and IRB approval of clinical protocols
If you are involved in writing a clinical trial protocol, this seminar will provide valuable suggestions about various aspects of a clinical protocol from initial synopsis to various elements of the protocol, role of various personnel in finalizing the protocol, and troubleshooting common issues. The basic elements of a clinical trial protocol, the dos and don’ts of clinical trial procedures, development of a new protocol, amending protocols, scientific and ethical review of clinical protocols will be discussed. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.
The following individuals or disciplines will benefit from attending this Webinar:
- Sponsors of INDs
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Drug discovery and development professionals (R&D and CMC)
- Clinical trial managers
- Project Managers and Clinical trial specialists
- Regulatory Compliance Associates and Managers
- People investing in FDA-regulated product development projects
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.
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.
