Strategies for Minimizing Preclinical Testing: Meeting FDA Requirements without Breaking the Bank
Date: June 18, 2025
Duration: 60 Minutes
Time: 12 PM EST
This seminar will discuss strategies to minimize animal testing while maximizing the development goals for faster development to market. The author will also discuss minimal GLP requirements for animal and cell culture testing in support of an IND and NDA or BLA.
The trickiest part of planning animal studies in support of a given product is figuring out what is absolutely necessary and what will be “good to have as well”. This seminar will help establish criteria for the same. If you are planning to initiate a clinical trial with a new drug or biological product, this seminar will give you useful tips from the presenters extensive experience about which animal studies to prioritize and which ones to defer till much later. The key GLP requirements for animal studies will also be discussed. This seminar will discuss the current rules and practical tips for being compliant with the FDA expectations.
- Preclinical testing needed to support a new IND
- FDA guidance documents for preclinical testing
- Current FDA regulations governing quality requirements for preclinical studies
- GLP and non-GLP studies in support of an IND
- Quality systems applicable to preclinical studies
- Best practices for getting FDA advice on completed and planned preclinical studies
The following individuals or disciplines will benefit from attending this Webinar:
- Drug discovery scientists
- Safety pharmacologists
- Toxicologists
- Scientists in lead optimization
- Project Managers
- Regulatory Vice Presidents, Directors and Managers
- Lab testing professionals
- Compliance professionals
- Auditors
- 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
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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.
