FDA Drug Approval Process
This web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH GCP E6 Guideline — Investigational Device Exemption (IDE) and abbreviated IDE processes. We will begin by reviewing the contents of an IND, and then follow the process of an IND submission. From there, the contents and approval process of an NDA submission will be discussed. This web seminar will also provide a foundation for those who require an understanding of the FDA new drug approval process, and help attendees become familiar with the regulatory landscape in which INDs and NDAs are developed and approved.
- Navigate the FDA approval process for a new drug
- Describe what an IND is, and identify the contents of an IND
- Describe what an NDA is, and identify the contents of an NDA
- Discuss the FDA IND and NDA review process
Who Should Attend
- Regulatory Affairs Personnel
- Quality Assurance Personnel
- Manufacturing Personnel
- Research Personnel
- Those that have to be familiar with the preparation of INDs and NDAs
- Those that have to understand the FDA new drug approval process
Marla Hoelle, BSN, RN, CCRA, ACRP-PM, PMP
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: firstname.lastname@example.org
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#: 0778-0000-20-035-L01-P. Released: 4/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.