Periodic Safety Reports: PSURs and PBRERs2018-10-24T16:20:39+00:00

Project Description

Periodic Safety Reports: PSURs and PBRERs

Course overview

Venue: Solent Hotel, Whiteley, Fareham

Date: 08 May – 09 May 2019*

The Periodic Safety Reports: PSURs/PBRERs course covers the evolution of the Periodic Safety Update Report (PSUR) into the new Periodic Benefit-Risk Evaluation Report (PBRER) format. Participants will gain a working knowledge of the evolving International Conference on Harmonisation (ICH) E2C guidelines for purposes of planning and writing periodic safety reports, and the changes required by the EU pharmacovigilance legislation implemented from July 2012. Group sessions and workshops will discuss the practical application of the guidelines to emerging data on drug products. Practical issues, such as 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 or PBRERs as well as those who have a basic knowledge which they wish to improve, and for those who are familiar with the old PSURs, but now need to learn more about the the new PBRERs.

*Please note that the course dates and programme may be subject to change.

 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

Aims of course

  • To analyse the ICH E2C Guideline for writing PBRERs
  • To understand the rationale for writing periodic safety reports
  • To critically appraise the format and content of periodic safety reports, and particularly the new requirements of the PBRER
  • To gain practical experience in the planning, writing and reviewing of PBRERs, particularly the challenges of the benefit-risk assessment
  • To explore the place of periodic safety reports in a robust pharmacovigilance system, and the synergies between the PBRER, Development Safety Update Report (DSUR) and the Risk Management Plan (RMP)

Learning Outcomes

On successful completion of this course delegates should be able to:

  • Analyse the purpose and scope of periodic safety reports and MAH holder responsibilities
  • 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

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
  • Signal and Risk Evaluation
  • Benefit-evaluation and integrated benefit-risk analysis
  • Reviewing and evaluating a PBRER – a regulator’s perspective
  • Modular approach to DSURs/PBRERs/RMPs

Fees

Cost Per Delegate:

£695 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)

Or

£1070 + VAT Standard

(Standard Registration)

Download Course Programme

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Booking options

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TESTIMONIALS

“Great background information, interactive workshops and knowledgeable speakers.”

Periodic Update Reports: PSURs & PBRERs Delegate 2018

“Very enjoyable course. The speakers were very knowledgeable and approachable.”

Periodic Update Reports: PSURs & PBRERs Delegate 2018

“A fantastic course. The workshops were very helpful. 

Periodic Update Reports: PSURs & PBRERs Delegate 2017

“Very well structured and great advice given. Was a friendly, easy environment to work in.

Periodic Update Reports: PSURs & PBRERs Delegate 2017

“Good facilitators with amazing background in PhV who are ready to pass on their knowledge and answer any questions.

Periodic Update Reports: PSURs & PBRERs Delegate 2017

“Excellent course that met all my learning needs. A lot of useful information was provided and the practical sessions were very helpful. The speakers were very knowledgeable and approachable.”

Periodic Update Reports: PSURs & PBRERs Delegate 2015

Course Leader

Kristina Strutt – Pharmacovigilance Head

Kristina is a registered physician, having studied medicine at King’s College Cambridge and the Middlesex Hospital in London.  She is a Member of The Royal College of Physicians and a Fellow of The Faculty of Pharmaceutical Medicine in the UK.  She holds specialist registration in pharmaceutical medicine with the GMC.

Kristina is an experienced pharmaceutical physician, having spent over 25 years in industry, following five years’ experience in the NHS.  She has worked in lead roles in the clinical development of products in the oncology and cardiovascular therapeutic areas, across all phases of development, and also in pre-launch and medical affairs activities.  In 2003 Kristina moved from clinical development into drug safety, when she became responsible for the Patient Safety organisation as the Regional Director for the UK R&D sites at AstraZeneca.

At the beginning of 2011, Kristina moved to Merck Serono S.A., based in Switzerland and Germany, to take up the position of Vice President, Head of Global Drug Safety.  She returned to the UK in 2015, spending 3 years as Senior Vice President, Head of Global Patient Safety at Ipsen Biopharm Ltd, before taking up her new position at Sanofi, based in Paris, France in February 2018.

Kristina is a lecturer on the Cardiff University MSc/Diploma in Clinical Research, for which she also served a four-year appointment as external examiner, and on the Cardiff University/BrAPP Postgraduate Course in Pharmaceutical Medicine. She is an examiner for the Faculty of Pharmaceutical Medicine, UK.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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