A Systems Approach to Good Pharmacovigilance Practice

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Course Information

Global, country and company specific events continue to challenge the ‘maturity’ of the PV system within each Marketing Authorisation Holder. There is a need to develop personnel to meet these challenges and improve how we provide information to support the safe use of medicinal products.

 We develop continuously how we think, communicate and plan globally and how to maintain the flexibility to act whether it is at a regional level, a specific country level, with a specific stakeholder including regulators or act on a person to person level. On top of this we need to assure that the PV system is functioning to plan.

 Many believe that the key to sustaining a mature PV system is the development of personnel to explore and appreciate the regulatory requirements and principles of design of the whole PV system with the purpose to operate effectively. An important part of this is how we share and deploy our experiences, how to manage risks and how to share issues.

 This course is an opportunity to explore the application of the European regulatory requirements to the global pharmacovigilance system and to share techniques for maintenance and improvement of the PV system in order to operate effectively, support improvement projects, and contribute to assurance of the operation of the global PV system.

The purpose of this course is to explore the complexity of the pharmacovigilance (PV) system, the purpose of activities within the PV system, what has to be done, how to monitor activities within the PV system, how to maintain the PV system and how to ensure compliance with regulatory requirements.

Delegates will explore the European Regulatory Requirements for PV. They will examine how the PV system and its quality system interact to achieve compliance with regulatory requirements to enable safe use of medicines. PV auditors will benefit from exploration of a systems approach to investigate systematically the Pharmacovigilance system and its quality system. Other Quality Assurance Personnel and PV practitioners will benefit from a ‘systems approach’ to implementing, monitoring and maintaining the PV system. The course uses presentations and workshops.

Who should attend?

• Auditors
• Pharmacovigilance Quality System Managers
• Pharmacovigilance scientists
• The QPPV

Benefits

Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to 

• A systematic investigation of the Pharmacovigilance System and its Quality System
• Examination of how the pharmacovigilance system and quality system interact to achieve compliance.
• The risk-based approach to auditing the PV system and quality system
• The maintenance of 'inspection readiness'
• Explore how to investigate the complex PV system
• Discussions about how to monitor and maintain the PV system and assure compliance

Course Objectives

Clarify what has to be done

• Explore application of the legal requirements

Explore how to do what has to be done:

• Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system.
• Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV.
• Explore how to investigate the complexity of the PV system.

Discus how to identify what is missing or what needs to be improved

• Discuss how to monitor and maintain the PV system and assure compliance

This course will assist delegates with:

• An understanding of key system principles,
• A practical approach to implementing, maintaining and monitoring the PV system and its quality system
• A procedure to share expertise to increase efficiency and confidence.

This course is structured to encourage delegates to:

• Discuss and develop ideas -  Share knowledge and experiences -  Solve specific problems.

 By the end of the course delegates will be able to:

• Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance.
• Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved.

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