FDA Drug Approval Process

This web seminar provides an overview of the drug development process and how the FDA approves new drugs. The Investigative New Drug (IND) contents and the New Drug Application (NDA) are described with reference to applicable FDA regulations and the phases of clinical trials required by the FDA.

Learning Objectives

• Describe the FDA’s role in drug development
• Describe the basics of the clinical trial process
• Describe the FDA review process for IND/NDA submissions
  

Who Should Attend

• Clinical Research Coordinators
• Clinical Research Associates
• Clinical Trial Managers
• Clinical Project Managers
• Regulatory Affairs Personnel
• Quality Assurance Personnel
• Manufacturing Personnel
• Research Personnel
• Personnel that have to understand the FDA new drug approval process
  

Instructor

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. 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 sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 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#: 0778-0000-21-060-L04-P. Released: 9/21. 

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