C5112 A System Approach to GPvP - running on 26th-28th November 2024 - 20% off the registration fee , using the discount code C511220, please enter this in the discount code box at checkout.
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, from the perspective of the Qualified Person Responsible for Pharmacovigilance (QPPV), quality assurance person and a PV auditor.
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.
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:
• Explore application of the legal requirements.
• Understand the role and responsibilities in the implementation of the PV and quality system within an organisation.
• 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.
• Discuss how to monitor and maintain the PV system and assure compliance.
Tutors will be comprised of (click the photos for biographies):
Jana Hyankova is an expert on pharmacovigilance (PV) with almost 20 years of working experience from several global pharma and service companies. Jana joined iVigee in 2023 and currently holds position of Head of PV department. She serves in EU QPPV and UK QPPV role and conducts PV audits for clients. Prior to joining iVigee, she held managerial pharmacovigilance roles at service company PrimeVigilance (former PharmInvent) as well as pharma companies (Bristol Myers Squibb, PharmaSwiss SA later Valeant Pharmaceutical International). Jana is a Medical Doctor who gained her medical education at the Charles University in Prague, Czech Republic. Outside of iVigee Jana is chairing PV Committee under Research Quality Association (RQA). She is an active speaker on conferences and courses for various associations such as the RQA, PIPA, ISoP and Conforum. She has also numerous publications in various scientific journals.
Please note timings may be subject to alteration.
Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance.
Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module.
Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance.
Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders.
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. Common PV audit/inspection findings on Quality System for PV.
Exploring an organisational model of the pharmaceutical company - cooperation between PV and external stakeholders.
Exploration of the legal responsibilities of the QPPV and the Marketing Authorisation Holder (MAH). Common PV audit/inspection findings on QPPV.
Construction of the PSMF and its purpose.
Common PV audit/inspection findings on PSMF.
Description of PV System.
Understanding the management of an RMP, cornerstone of PV safety communications, and direct healthcare professional communication, and the required quality systems.
Safety communication strategies.
Common PV audit/inspection findings on Risk Management System.
Regulatory and quality requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. Common PV audit/inspection findings on PSURs.
To explore the compilation and submission of the PSUR.
Exploration of safety data collection, processing and reporting, quality and data management. Common PV audit/inspection findings on data collection, processing and reporting of safety data.
Exploration of regulatory requirements and good practice in signal management process and the quality requirements. Common PV audit/inspection findings on signal management.
Explorations of provisions for post-authorisation safety studies applicable in the European Union (EU), including legal framework, quality systems and PASS process. Common PV audit/inspection findings on PASS management.
Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals.
Exploration of types of PV and inspections, how to prepare for inspections and do's and don’ts.
Preparation for a regulatory inspection
Exploration of requirements regarding risk-based PV audits, defining risk-based approach, and how to prepare for audits. Common PV audit/inspection findings on PV Audits.
Preparation for the QPPV audit/inspection
Preparation of responses to inspection and audit findings, management of CAPA plans and effectiveness check. Common PV audit/inspection findings on CAPA management.
Preparation of a CAPA.
Course material will be available in PDF format for delegates attending this course. The advantages of this include:
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
Accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to stay for additional nights or double occupancy, please contact the us -courses@therqa.com in the first instance.
*These can be selected during the booking process, based on per person, per night.
As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.
Please note that all venue and accommodation enquiries should be sent directly to RQA.
23 Points
Develop
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet
Pharmacovigilance Auditing eBooklet