Large and small pharmaceutical companies alike face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The specialized operational configurations of firms present complex challenges to meeting international requirements effectively. Pharmacovigilance audits can contribute to regulatory compliance and support industry best practices. This course will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company’s pharmacovigilance operations to applicable best practices.
- Discuss why the pharmacovigilance audit is important to ensure Good Pharmacovigilance Practice
- Explain the impact of FDA regulations on international safety reporting and review methods
- Describe the objectives and components of a pharmacovigilance audit
- Describe the requirements of all applicable regulatory bodies for the company’s products
- Inspect company practices in relation to drug safety across the product lifecycle
- Review detailed documentation on AE case processing
- Clinical Safety/Pharmacovigilance
- Regulatory Affairs Professionals
- Quality Management Specialists
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Day 1: 8:30 a.m. – 5:00 p.m.
- The Pharmacovigilance Audit: Typical pharmacovigilance current process model; best practice approach to enhancing process model; achieving best practices through the pharmacovigilance audit; scope; company sources of information to be examined; representative findings from case study
- The Pharmacovigilance Risk Profile: Knowing which gaps to close; pharmacovigilance concepts; example of an effective supporting information architecture; example of how signaling supports Good Pharmacovigilance Practice
- Signaling Fundamentals: BCPNN – Bayesian Confidence Propagation Neural Network; PRR – Proportional Reporting Ratio; MGPS - Multi-item Gamma Poisson Shrinker
- Preparing for a Pharmacovigilance Inspection: Overview eight domains of pharmacovigilance; strategy; organizational structure and operating model; skills and training; quality management; SOPs/Documentation; business processes and communication; systems; surveillance; eight domains of pharmacovigilance
- Practical Tips: Importance of QPPV in Europe; need for oversight of the pharmacovigilance system; ensuring information on adverse events is accessible; suitability of people; requirements for SOPs; processing of ICSRs; electronic reporting; Periodic Safety Update Reports (PSURs); signal detection practical tips; quality assurance
- Series of Interactive Case Studies: Based on five real-world inspections
- Mock Audit Case Studies
- Requirements for active surveillance
- Expedited reporting in the US and EU
- Qualified Person for Pharmacovigilance - what they must do
- Signaling and data mining: laws, regulations, and guidances in the US and EU
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 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# 0778-0000-12-049-L01-P. Released 9/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.