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!
Worldwide Fast Track, Priority Review, and Accelerated Approval Options
Upcoming Courses
After spending years on the development and clinical research phase, you want to minimize the time to approval of your compound. This can be done by ensuring that your filing is complete, well written, and uses any of the available accelerated approval options, if your compound qualifies. However, Fast Track, Priority Review, or Accelerated Approval options need to be planned for and negotiated with a Health Authority well in advance of a marketing application submission. In this web seminar, we will discuss the program and/or compound qualifications needed, on a global scale; how these programs are the same or different; and how they overlap. We will also examine how these programs, if planned into the development strategy, can help reduce marketing application review time.
- Describe Fast Track, Priority Review, and Accelerated Approval options globally
- Explore the criteria that needs to be met to qualify for these options
- Discuss the similarities and differences of these programs
- Discuss the benefits of each, including time savings during the application review process
- Obtain, write, and submit the appropriate information to be granted one or many of these approval mechanisms
- Discuss what needs to be done, prior to the marketing application, to help facilitate a speedy marketing application review using Gleevec and Jevtana as case studies
- Individuals who want an introduction to accelerated approval options on a global scale
- Regulatory Affairs Professionals
- Clinical Research Professionals
- Research and Development Professionals
- Project Managers
Meredith Brown-Tuttle, R.A.C.
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#: 0778-0000-11-066-L01-P. Released: 8/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
