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Drug Safety Research Unit

EU Regulations and Guidelines for Pharmacovigilance

Practical Information

Commencing Date:
tba
Language:
English
Location:
London United Kingdom


Teaching Methodology:
Blended Learning


European Fees:
1190 British Pound (GBP)
Scholarship Possibilities:
No

Course Contact

Fiona Coxsell

eandt@dsru.org


Website

Drug Safety Research Unit

University Accreditation: No

Individual Course

Description

Introduction In 2007 pharmacovigilance regulations were brought together in an update of Volume 9A of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use. It brings together guidance on the requirements, procedures, roles and activities of the various stakeholders on the collection, verification and presentation of adverse reaction reports in order to exchange information within the EU. Volume 9A also incorporates international agreements reached in this arena within the framework of the International Conference on Harmonisation (ICH). Thus it attempts to harmonise the disparate regulations and the practice of pharmacovigilance in the pharmaceutical industry and regulatory authorities. This course gives delegates a professional working knowledge of EU pharmacovigilance requirements and an overview of the processes and procedures necessary to ensure compliance. Aims - To explore the law and guidance defining EU Pharmacovigilance requirements and issues associated with their current interpretation - To analyse the operational aspects of case processing, from receipt to electronic reporting, both for individual cases and the construction of aggregate reports such as Periodic Safety Update Reports (PSURs) - To review critically, the qualitative aspects of the pharmacovigilance system such as quality assurance, audit, compliance, post-authorization safety studies signal detection, risk management and communication - To explore critically, the role of the Qualified Person in Pharmacovigilance (QPPV) - To analyse the impact of licensing agreements on pharmacovigilance This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.

Outcomes

On successful completion of this course delegates should be able to: - Analyse and explain the expectations and scope of the EU pharmacovigilance system - Choose, justify and assemble the appropriate tools and manage the processes necessary to facilitate regulatory compliance - Appraise the role and responsibilities of the QPPV - Critically discuss the broad issues associated with licensing agreements

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered