Course Description

This web seminar will describe the content expected in the toxicology section of an IND application. Participants will learn how to effectively present nonclinical safety data, including dose-response relationships, target organ toxicity findings, and safety margins that support the proposed clinical trial design and starting dose selection. The course will also cover regulatory guidelines for toxicology study design, data interpretation strategies, and methods for addressing potential safety concerns to facilitate FDA review and approval of the IND application.

Learning Objectives

• Identify appropriate content for an IND toxicology section
• Describe examples of well written IND toxicology sections
• Discuss clinical toxicology considerations for different patient populations

Who Should Attend

• Entry-Level Regulatory, Clinical, Manufacturing, Technical, and Quality Personnel who desire a basic understanding of drug toxicology details to include in an IND application
• Management, Legal, and other Personnel who must be familiar with the essentials of the drug approval system and the preparation and submission of related documents

Instructor

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S., F.R.A.C.P.

Click here for complete trainer biographies

Registration Fees

$835*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1 hours (0.1 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-056-L99-P. Released: 8/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.