A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
Drug and Device Regulatory Submissions: A Comparison
Upcoming Courses
This web seminar is designed to provide details on what goes into FDA regulatory submissions for drugs and devices, and highlight the differences between the programs and Centers (CDER and CDRH) dealing with these products. Drug submissions may include an Investigational New Drug Application (IND), a New Drug Application (NDA), 505(b)(2) application, an Abbreviated New Drug Application (ANDA) for generic drugs, orphan drugs and supplemental filings, and contain information on manufacturing controls and clinical trial outcomes. Device submissions may include 510(k), PMA and PDPs, and de novo applications. Requirements for device submissions will depend on the device type and classification, as well as the available performance and safety information. The decision pathways needed to ensure the necessary information has been provided will be presented.
- Differentiate between drug and device FDA submissions
- Identify information and decisions needed to complete submissions
- Discuss the purpose of submission sections
- Discuss the impact of clinical data in submissions
- Regulatory Affairs Professionals who require an understanding of the pharmaceutical and medical device approval systems
- Management, Legal, and other personnel who must be familiar with the various approval process systems and submissions of related documents
Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.
Click here for complete trainer biographies
$695
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.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 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#: 0778-0000-15-080-L01-P. Released: 8/15.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
