Periodic Safety Reports – PSURs/PBRERs and relationship to DSURs (Hybrid Event)

Course Overview

The Periodic Safety Reports – PSURs/PBRERs and relationship to DSURs course covers the rationale and theory behind the evolution of these reports. It offers an understanding of the respective International Conference on Harmonisation (ICH) guidelines (E2C and E2F), and practical advice designed to give you a working knowledge of planning and writing them. 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, and the evaluation of the emerging data will be addressed, particularly the challenges of writing the benefit-risk assessment section of the report.

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.
The in-person session of this course will only proceed when a minimum number of participants is met. Should this number not be reached, the registered participants will be notified at least three weeks prior to the course.

Our courses are recognised by PharmaTrain.

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 updates

How our courses work

• Taught over two days
• A combination of lectures and interactive workshops
• Network with other delegates and speakers via scheduled discussion sessions (virtual delegates), and during coffee and lunch breaks (in-person delegates)
• Full access to PDFs of the presentations afterwards
• Use this course as part of your Continuing Professional Development (CPD)
• Refreshments and lunch provided (in-person delegates)
• Virtual delegates will be sent a link in advance to enable you to join the live course at the stated time

Aims of the course

• To understand the rationale for writing periodic safety reports
• To analyse the ICH E2C and E2F Guidelines for writing PSURs/PBRERs and DSURs
• To critically appraise the format and content of periodic safety reports
• To gain practical experience in the planning, writing and reviewing of periodic reports, the gathering and assessment of data, and particularly the challenges of the benefit-risk assessments
• To gain an understanding of how periodic 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 the responsibilities of the MAH and Sponsor
• Assemble and appraise a PBRER from diverse information sources and explain the management steps in report submission
• Critically evaluate the interval data for a PBRER in the context of signal and benefit-risk evaluation
• Contribute to the relevant sections of a DSUR, and understand the synergies and differences between DSURs and PSURs/PBRERs

Key topics

Programmed features:

• History and rationale for writing periodic safety reports
• Regulatory aspects of periodic safety reports
• Core Safety Information
• Planning, writing and reviewing a PBRER
• Patient exposure for PBRERs
• Signal and Risk Evaluation
• Benefit-evaluation and integrated benefit-risk analysis
• Presenting data from clinical studies and literature
• Reviewing and evaluating a PBRER – a regulator’s perspective
• Modular approach to DSURs/PBRERs/RMPs
• Content of DSURs

Our fees

Please note, VAT is only applicable for delegates based in the UK.

Cost Per Delegate:

• Academic

  £620 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - Virtual

• Academic

  £775 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - In-Person

• Standard

  £952 + VAT

  Virtual

• Standard

  £1190 + VAT

  In-Person

Registration fees include electronic access to all course materials. Lunch and refreshments are provided for those attending in-person.

Book now

• 1 May 2024 - 2 May 2024

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  UK Based International

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