| Starts: | Thursday December 03, 2009 at 8:00am |
|---|---|
| Ends: | Friday December 04, 2009 at 3:30pm |
| Event Type: | Training/Seminar |
| Region: | Washington D.C. Metro Area |
| Location: |
PERI Training Facility Arlington, VA US |
| Price: | $1025 until 10/19/2009! |
| Website: | http://www.peri.org/course_details.cfm?course=1962 |
| Industry: | pharmaceuticals |
| Keywords: | Rems, Risk Evaluation Strategy, Risk Mitigation Strategy, Rems Program, Program Evaluation, Risk Management, Risk Assessment, Risk Communication |
| Intended For: | Those involved in clinical research, clinical safety, marketing and marketing research, medical affairs, pharmacoepidemiology, pharmacovigilance and drug safety, project management, and regulatory affairs as well as anyone interested in learning more abou |
| Organization: | PERI |
This hands-on training focuses on developing risk evaluation and mitigation strategies (REMS). It will help attendees plan and develop REMS programs in their company. The course is built around case studies and interactive sessions, with supporting intermittent didactic presentations on risk assessment, risk management planning, risk communication, and program evaluation. Participants will be divided into groups to design elements of their own risk management program and present various elements of their programs throughout the course.
Key Topics: • Interactive Group Workshops • REMS definition and elements • Key issues in REMS evaluation • Current Regulatory Status of Risk Management • Internal/External Communication & Stake holder Analysis • Components of Risk Minimization Action Plan (RiskMAP) • Risk Communication & Tools • Other Interventions in Risk Minimization • Evaluation of RiskMAP Effectiveness • Financial & Legal Implications of Risk Management