Short Course
Periodic Safety Reports: PSURs/PBRERs and Relationship with DSURs (Online)
Venue
Online
Date
21 April 2027 - 22 April 2027
Course overview
The Periodic Safety Reports course aims to equip attendees with an understanding of the reasons behind the need for these reports, knowledge of the details of the contents, and the practical skills required to write individual sections and compile these into the full report. It offers an understanding of the respective International Conference on Harmonisation (ICH) Guidelines (E2C and E2F), and the EU Good Pharmacovigilance Practices (GVP) Module VII. Individual sections of the PSUR/PBRER are covered in detail, with practical advice designed to give you a working knowledge of how to plan and write these reports.
Group sessions and workshops will discuss the practical application of the guidelines to emerging data on drug products. Issues such as the planning and writing of reports, the collection and presentation of the emerging data, and the analysis of new data in the context of cumulative information will be addressed, particularly the challenges of writing the benefit-risk assessment section of the PBRER. This course has been developed for those who have no previous training in writing PSURs/PBRERs and/or DSURs, as well as those who have a basic knowledge which they wish to improve.
Please note, the course dates and programme may be subject to change.
Who should attend
This course is aimed at:
- Pharmaceutical industry personnel from areas including drug safety, medical affairs and regulatory affairs
- Medical writers
- Staff from regulatory authorities
- Others with an interest in learning more about periodic safety reports
How our course works
- Taught over two days online
- A combination of lectures and interactive workshops
- Interact with other delegates and speakers via scheduled discussion sessions
- Full access to PDFs and recordings of the presentations afterwards
- Use this course as part of your Continuing Professional Development (CPD)
- Delegates will be sent a Teams link in advance to enable you to join the live course at the stated time
- Certificate of attendance provided upon completion of the course
Our fees
Registration fees include electronic access to all course materials.
Please note, VAT is only applicable for delegates based in the UK.
Cost Per Delegate:
Academic
£775 + VAT
(Academic Units, Public Sector Organisations, Registered Charities)
Standard
£1190 + VAT
Aims of the course
- To appreciate the rationale for writing periodic safety reports
- To understand the ICH E2C and E2F Guidelines for writing PBRERs and DSURs respectively, and the EU GVP Module VII for PSURs
- To critically appraise the format and content of periodic safety reports
- To gain practical experience in the planning, writing and reviewing of periodic safety reports, the gathering and assessment of data, and the challenges of analysing the data and presenting these analyses concisely and comprehensively
- To gain an understanding of how periodic safety reports are assessed, and relevant quality measures
- To explore the place of periodic safety reports in a robust pharmacovigilance system, and the synergies between PSURs/PBRERs, DSURs and Risk Management Plans (RMPs)
Learning outcomes
On successful completion of this course delegates should be able to:
- Analyse the purpose and scope of periodic safety reports and MAH/Sponsor responsibilities
- Assemble and appraise a PSUR/PBRER, from diverse information sources, and explain the management steps in report submission
- Critically evaluate interval data for PSURs/PBRERs in the context of signal and benefit-risk evaluation
- Understand the synergies and differences between DSURs and PSURs/PBRERs
Programmed features
- History and rationale for writing periodic safety reports
- Regulatory aspects of periodic safety reports
- Reference Product/Safety Information
- Planning, writing and reviewing a PSUR/PBRER
- Patient exposure for PSURs/PBRERs
- Safety signal and risk evaluation
- Benefit evaluation and integrated benefit-risk analysis
- Analysing and presenting data from clinical studies and literature
- Reviewing and evaluating a PSUR – a regulator’s perspective
- Modular approach to PSURs/PBRERs, DSURs and RMPs
- Content of DSURs
- Harmonising the production of PSURs/PBRERs and DSURs – a practical approach
Download programme
Please download the relevant programme for your chosen course date.
21 April 2027 - 22 April 2027
Book now
- 21 April 2027 - 22 April 2027
Limited places available - register early to secure your spot
Our courses are CPD accredited by the Faculty of Pharmaceutical Medicine and are recognised by PharmaTrain.