Periodic Safety Update Reports (PSURs)
Periodic Safety Update Reports (PSURs)
Venue: Solent Hotel, Rookery Avenue, Whiteley, Fareham, Southampton
Date:
13 - 14 Jun 2012
Cost per delegate:
£945.00 + VAT
or
£615.00 + VAT (academic units, public sector organisations, registered charities)
Course Outline
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
Key Topics
Programme features
- History of PSURs
- Format and content of a PSUR - the ICH E2C guideline
- Planning and writing a PSUR
- Summary bridging reports and addendum to PSUR
- CIOMS V group recommendations
Learning 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