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.
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.
Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system
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.
The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system.
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.
The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system.
Construction of the Pharmacovigilance System Master File and its purpose.
Description of PV System.
Information flow and responsibilities of the sponsor.
Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor.
Information flow and responsibilities of the sponsor.
Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor.
Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management.
Exploration of how EudraVigilance supports the PV system.
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.
A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication
Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals.
Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution.
Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution.
Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution.
To explore the compilation and submission of the PSUR.
Exploration of the legal responsibilities of the QPPV and the MAH.
To explore the challenges faced by the QPPV.
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.
You will need a stable internet connection, a microphone and a webcam.
23 Points
Develop
Management of the Training and Competency of Personnel in GxP and Research Environments
Pharmacovigilance Auditing