Course Description

This web seminar will discuss the key aspects of managing a successful pre-IND or pre-IDE meeting with the FDA. Participants will learn strategic approaches to effectively communicate with regulatory authorities, including how to frame critical questions and present compelling scientific rationale for their development programs. The course emphasizes best practices for maximizing the value of these crucial regulatory interactions while minimizing potential delays or setbacks in the drug or device development process.

Learning Objectives

• Request a meeting with the FDA
• Prepare a meeting information package
• Anticipate the timeline needed for the pre-IND/IDE meeting

Who Should Attend

• Entry to Mid-Level Regulatory Professionals who have 0-5 years of regulatory experience and are looking to learn the “next level” of regulatory, beyond submission preparation
• Drug or Device Development Team Members that would like to learn more about regulatory meetings and regulatory strategy when negotiating with the FDA

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#:0778-0000-25-054-L99-P. Released: 8/25. 

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