FDA Rules for the Content, Tone and Format of an Investigator’s Brochure
(Investigator Brochure template is provided to attendees.)
Date: February 19, 2025
Duration: 60 Minutes
Time: 12 PM EST
This webinar, presented by a leading industry expert who authored more than 50 Investigator’s Brochures, will discuss FDA expectations from IBs, writing styles, common errors, and review findings. The seminar will list the different areas of IB with tips and guidance for what kind of information to include and avoid in an IB. Writing tips for style, tone, citations, and presenting contextual information for an appropriate balance of encouraging information for an investigational product without creating undue hype for it will be discussed. The presenter will use case studies and examples to highlight how one can present all information in a precise, supportive and FDA-acceptable manner while maintain high level of appeal for the product in the eyes of the investigators and study teams. Dos and don’ts, common areas of concern, and potential solutions will be discussed. Best practices for formatting, reviewing, finalizing, revising, and training personnel will be presented. This seminar is a must for new clinical trial professionals and a good update for the experienced ones to understand the current regulatory requirements for IB.
Areas Covered in the Session:
- Essential components of an Investigator’s Brochure
- Components of SOP and other regulatory processes for IBs
- What information to include or avoid in an IB (Investigator’s Brochure Content and FDA guidance)
- Best practices for style, tone, formatting, and presentation of IBs
- Ways for balancing positive, negative and neutral information in an IB
- Common FDA findings of unacceptable IB statements
Who will benefit:
- 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.
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.
