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

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:
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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​
Date: November 30, 2018
Time: 12 PM EST        
​Duration: 60 Minutes

Speaker: Mukesh Kumar
PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com