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!
FDA Review of Integrated Safety Summaries (ISS) During the NDA Review
Upcoming Courses
The FDA has a detailed and complex set of instructions for its medical reviewers assigned to review the clinical (and non-clinical) safety sections of an NDA. They explain what is important and what is not important; what to look for; what to disbelieve and take with a grain of salt; and how to put together an analysis of the clinical safety section of an NDA submission. These instructions are complicated and “eye-opening” for the industry and those who prepare NDAs. All companies should be aware of the “ground rules” and what the FDA is expecting to see from companies. Some of the areas that companies labor over are systematically given little weight by the reviewer or even ignored. In this web seminar, we will go over the instructions the FDA follows in their safety reviews and assist learners to better handle safety analyses and NDA preparation.
- Identify what the FDA looks for in the safety section of an NDA
- Describe what is important and what is given less weight during the safety review
- Critically review company procedures used to prepare the safety section of an NDA
- Structure a better corporate procedure to prepare an NDA safety section
- Medical Personnel preparing NDA safety submissions/Integrated Safety Summaries
- Regulatory Personnel
- Drug Safety Personnel handling clinical trial safety reports
- Drug Safety Operations Personnel
Barton Cobert, M.D., F.A.C.P., F.A.C.G.
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 1-800-856-2556 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 mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-14-078-L01-P. Released: 10/14.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
