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Drug Safety Research Unit

Periodic Safety Reports PSURs/ PBRERs

Practical Information

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


Teaching Methodology:
Blended Learning


European Fees:
1070 British Pound (GBP)
Scholarship Possibilities:
No

Course Contact

Drug Safety Research Unit

University Accreditation: No

Individual Course

Description

Introduction A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a medicinal product to competent authorities at defined time points, post-authorisation. These reports are expected to provide succinct summary information together with a critical evaluation of the risk-benefit balance of the product in the light of new or changing information. This evaluation should ascertain whether further investigations need to be carried out and whether changes should be made to the marketing authorisation and product information. PSURs must be submitted for all registered products regardless of marketing status. This course provides delegates with a working knowledge of the International Conference on Harmonisation (ICH) E2C guidelines for purposes of planning, writing and reviewing PSURs. Group sessions and workshops are included to address practical issues and application of the guidelines. Aims - To analyse the ICH E2C guidelines for writing PSURs - To critically appraise the operational aspects of the planning, construction and frequency of submission of PSURs - To explore the application of the guidelines to reporting safety data - To critically review the key sources of adverse reaction case information - This course is part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.

Outcomes

On successful completetion of this course delegates should be able to: - Analyse the purpose and scope of PSURs and MA holder responsibilities - Assemble and appraise a PSUR from diverse information sources and explain the management steps in report submission - Critically evaluate data within PSURs for purposes of signal detection

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