Drug Development and FDA Regulations

Course Description

This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.

Learning Objectives

• Describe the FDA’s role in drug development
• Review the logic behind the drug development process
• Discuss IND/NDA submissions
• Describe the basics of the clinical trial process
• Describe the FDA review process for IND/NDA submissions
• Navigate the three major FDA regulations: GCP, GLP and GMP

Who Should Attend

• Those who want an understanding or greater understanding of the drug development process
• Clinical Research Associates
• Auditors
• Regulatory Affairs Professionals
• Quality Assurance Personnel
• Manufacturing Personnel

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

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 3 hours (0.3 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#: 0778-0000-22-012-L04-P. Released: 3/22. 

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