4 Courses

COURSE INFORMATION In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. WHO SHOULD ATTEND? * Auditors * Pharmacovigilance Quality System Managers * Pharmacovigilance scientists * The QPPV. COURSE 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. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): JANA HYANKOVA Head of PV Department, IVIGEE Services a.s. -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 08:30 WELCOME, REGISTRATION, COURSE OBJECTIVES AND INTRODUCTION TO WORK GROUPS Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 THE REGULATORY FRAMEWORK FOR PHARMACOVIGILANCE Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 THE PHARMACOVIGILANCE SYSTEM Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 BREAK 11:00 WORKSHOP 1 AND FEEDBACK Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 THE QUALITY SYSTEM FOR PHARMACOVIGILANCE Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 LUNCH 14:00 WORKSHOP 2 AND FEEDBACK The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 THE QUALITY SYSTEM FOR PHARMACOVIGILANCE Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 DESCRIPTION OF PV SYSTEM 15:30 BREAK 15:30 WORKSHOP 3 AND FEEDBACK The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 THE PHARMACOVIGILANCE SAFETY MASTER FILE Construction of the Pharmacovigilance System Master File and its purpose. 17:00 WORKSHOP 3 AND FEEDBACK Description of PV System. 18:00 END OF DAY DAY 2 08:30 DRUG SAFETY IN THE CLINICAL TRIAL ENVIRONMENT - PART 1 Information flow and responsibilities of the sponsor. 09:30 WORKSHOP 4 AND FEEDBACK Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 BREAK 11:00 DRUG SAFETY IN THE CLINICAL TRIAL ENVIRONMENT - PART 2 Information flow and responsibilities of the sponsor. 12:00 LUNCH 13:00 WORKSHOP 5 AND FEEDBACK Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 PROCESSING OF SAFETY DATA Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 BREAK 15:30 EUDRAVIGILANCE Exploration of how EudraVigilance supports the PV system. 16:15 SIGNAL DETECTION AND EVALUATION/RISK BENEFIT ASSESSMENT: PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 RISK MANAGEMENT PLANS A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 END OF DAY DAY 3 08:30 THE PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 DEVELOPMENT SAFETY UPDATE REPORTS (DSURS): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 PERIODIC SAFETY UPDATE REPORTS (PSURS)/PERIODIC BENEFIT RISK EVALUATION REPORTS (PBRERS) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 BREAK 11:00 PERIODIC SAFETY UPDATE REPORTS (PSURS)/PERIODIC BENEFIT RISK EVALUATION REPORTS (PBRERS) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 WORKSHOP 6 AND FEEDBACK To explore the compilation and submission of the PSUR. 13:00 LUNCH 13:30 ROLE OF THE QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 BREAK 15:00 WORKSHOP 7 AND FEEDBACK To explore the challenges faced by the QPPV. 15:30 END OF COURSE -------------------------------------------------------------------------------- EXTRA INFORMATION Face-to-Face Course COURSE MATERIAL This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. THE ADVANTAGES OF THIS INCLUDE: * Ability for delegates to keep material on a mobile device< * Ability to review material at any time pre and post course * Environmental benefits – less paper being used per course Access to an online course group to enhance networking You will need a stable internet connection, a microphone and a webcam. CPD POINTS 23 Points   DEVELOPMENT LEVEL Develop

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

Proactive risk management is a major component of good pharmacovigilance practice. This module sets out the principles of risk management planning and outlines regulatory requirements for risk management plans in regions that are major markets for medicinal products.