PTI - international

• Understand the fundamentals behind product safety and risk management and identify all the components of effective risk management
• Assess risk effectively in the pre-clinical and clinical stages of drug development and protect patient safety
• Assess risk and monitor product safety in the post-approval marketing stage
• Establish a link between clinical and post-approval marketing teams to ensure generated safety data is a accurately communicated
• Institute good pharmacovigilance practices to ensure the proper detection and handling of adverse events
• Use data effectively to conclude reasonable management of risk
• Comply with FDA expectations for risk management programs and avoid regulatory citations
• Establish an effective risk management program and improve your standing with the agency

PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-04-080-L04, Initial release: 01/2004.