Strategies for Minimizing Preclinical Testing: Meeting FDA Requirements without Breaking the Bank

Date: June 18, 2025
Duration: 60 Minutes
Time: 12 PM EST

Animal testing is required before a new drug or biological product can be tested in clinical trials and for market approval. There are several guidance documents to advice developers of the kind of animal testing to do for a given product. However, developers need to strategize what animal tests are needed, at which stage of development, and at what scale. Also, confusion exists about the use of new screening technologies such as in vitro assays and in vivo models to predict and detect adverse events. At early stages in development, the goal of the development team should be to maximize resources to clinical testing. At the same time, sufficient toxicity studies are needed to reasonably predict adverse events expected with a given drug or biologic. The balance between necessity and curiosity is needed at all stages in development.

​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.

Why should you attend:
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. 
 
Areas Covered in the Session:
  • 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
Who will benefit:
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

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.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com