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!
Risk Management Strategies for International Regulatory Requirements
Upcoming Courses
This web seminar will explain the need for risk management, describe the different regulatory requirements in the U.S. and Europe, explain how to develop Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Programs (RiskMAPs), and give examples of approaches to risk assessment both pre- and post-marketing. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful risk management is vital to product longevity, consumer confidence, and regulatory compliance. This web seminar will also provide learners with the regulatory references, processes, best practices, and analysis techniques to assess, minimize, and manage risk, avoid product recall, and meet international regulatory requirements.
- Work to international standards by meeting regulatory requirements for risk management
- Perform risk assessment
- Develop REMS and RiskMAPs
- Identify differences between U.S. and European legal requirements
- Drug Safety Personnel
- Regulatory Affairs Professionals
- Clinical Development Personnel
Steve Jolley
Click here for complete trainer biographies
1.5 hours 1:00 – 2:30 p.m. Eastern
December 14, 2011
$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#: 0778-0000-11-063-L01-P. Released: 9/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
