Periodic Safety Reports – PSURs/PBRERs & Introduction to DSURs2019-08-09T12:54:52+00:00

Project Description

Periodic Safety Reports – PSURs/PBRERs & Introduction to DSURs

Course overview

Venue: Solent Hotel, Whiteley, Fareham

Date: 06 May – 07 May 2020*

The Periodic Safety Reports – PSURs/PBRERs & Introduction 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 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

How our courses work

  • Taught over two days
  • Small class size allows for one-to-one interaction with expert tutors
  • A combination of short lectures, practical workshops and interactive discussion sessions
  • Taught by a panel of expert speakers (minimum of four speakers per course) from industry, regulatory authorities and academia
  • Course materials including presentations, workshop material and suggested reading documents are made available electronically during the course
  • The agenda provides ample opportunity to network with expert speakers and your fellow delegates

Lunch, refreshments and all course materials are included in the registration fee.

Aims of 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

Fees

Cost Per Delegate:

£775 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)

Or

£1190 + VAT Standard

(Standard Registration)

Registration fee includes lunch, refreshments and electronic access to all course materials.

Download Course Programme

Click here to download the programme

DOWNLOAD PROGRAMME

Booking options

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TESTIMONIALS

“Very good meeting. Very nice, approachable and knowledgeable presenters.”

Periodic Safety Reports Delegate 2019

“Great presentations, extremely knowledgeable presenters, amusing and interactive sessions. I really enjoyed all the sessions, especially the workshops!”

Periodic Safety Reports Delegate 2019

“Having the practical sessions really helped but into practice what we had learnt. The content of slides was very informative and questions were answered to my understanding.”

Periodic Safety Reports Delegate 2019

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

Periodic Safety Reports Delegate 2018

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

Periodic Safety Reports Delegate 2017

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

Periodic Safety Reports Delegate 2017

Periodic Safety Reports 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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