• Structures and processes of a quality system and a pharmacovigilance system
• Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Quality Manual requirements, content, and maintenance
• Safety Data Exchange Agreements across clinical study programs and post-marketing, including the development, regulatory requirements, and quality oversight
• Recommendations for Pharmacovigilance System Inspection Readiness
• Design of strategy and methodologies for Risk Based Audits
• Corrective and Preventative Action (CAPA) Plan preparation and effectiveness checks

This program is designed for professionals involved in:

• Quality assurance and compliance of the pharmacovigilance system
• Pharmacovigilance auditors
• Drug safety and  pharmacovigilance personnel responsible for compliance, training, pharmacovigilance agreements, and/or pharmacovigilance quality documents
• Pharmacovigilance activities at a pharmaceutical company or service provider
• Pharmacovigilance personnel who are considering the Pharmacovigilance Quality Management System field as a future career path

A working knowledge of safety and pharmacovigilance principles is necessary in order to gain maximum benefit from the course.

At the conclusion of this course, participants should be able to:

• Describe how to design, develop, and manage a quality system related to your pharmacovigilance system
• Explain the components of the Pharmacovigilance Quality Manual
• Describe the process for the development and maintenance of the Pharmacovigilance System Master File
• Analyze how the pharmacovigilance quality system integrates with the pharmacovigilance system
• Discuss the development, maintenance, and quality oversight of pharmacovigilance SOPs and pharmacovigilance related documents, including Safety Management Plans and Pharmacovigilance Agreements across clinical study programs and post-marketing
• Assess the effectiveness of the Quality Management System
• Explain Quality Risk Management Planning for risk-based audits of the Pharmacovigilance System and Quality System
• Define the scope of pharmacovigilance audits, including process audits, drug specific pharmacovigilance audits, and business partner pharmacovigilance audits
• Describe how to prepare for audits and inspections
• Practice preparing responses to a pharmacovigilance audit and inspection findings