Risk Benefit Assessment in Pharmacovigilance2019-10-09T11:20:55+00:00

Project Description

Risk Benefit Assessment in Pharmacovigilance

Course overview

Venue: Solent Hotel, Whiteley, Fareham

Date: 07 Oct – 08 Oct 2020*

Risk benefit assessment is vital during the whole life cycle of products. All risks must be considered in the context of benefits. The underlying principles of assessment are the same whether pre- or post-marketing. For each medicine there is a balance between risk and benefit, but the perspective of different stakeholders (regulator, marketing authorisation holder, academic, patient, or prescriber) may vary. The Risk Benefit Assessment in Pharmacovigilance course enables delegates to explore the relationship between risk and benefit, plus review the integration of appropriate strategies within risk management plans.

*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 pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
  • Pharmaceutical physicians completing the Drug Safety Surveillance module of Pharmaceutical Medicine Speciality Training (PMST)
  • Staff from regulatory authorities

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 develop knowledge and understanding of the principles of risk benefit assessment, plus methods available for quantitative risk benefit analysis and their practical application in decision making
  • To critically analyse factors associated with drug safety signals, the appropriate application of signal detection methodology and its contribution to safety monitoring and risk management
  • To critically appraise with current regulatory legislation and guidelines relevant to risk management plans and to recognise and justify their importance in helping ensure patient safety
  • To analyse and review relevant documents for communicating risk benefit (including patient information leaflets, data sheets and safety alerts)
  • To analyse recent challenges faced by regulators and marketing authorisation holders, critically review lessons learnt and outline future strategies for optimising pharmacovigilance activities to prevent withdrawal from the market

Learning Outcomes

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

  • Analyse and evaluate a safety signal
  • Undertake a risk benefit analysis of a newly marketed medicinal product, make and justify appropriate recommendations for communicating the updated information
  • Differentiate between the various regulatory actions possible to address drug safety signals
  • Recommend and justify options for crisis management of a safety signal

Key Topics

Programmed features:

  • Principles of risk benefit assessment and management
  • Familiarity with CIOMS IV report
  • Evaluating signals
  • Reporting and summarising safety data at registration and for the PSUR
  • Variations, urgent safety restrictions, licence suspension and withdrawal
  • European procedures and PDUFA III
  • SPCs and PILs
  • Crisis management


Cost Per Delegate:

£775 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)


£1300 + VAT Pmst



£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


Booking options

Book now


“Excellent speakers! The workshops were insightful and useful.”

Risk Benefit Course Delegate 2018

“Well structured, comprehensive content with clear presentations.”

Risk Benefit Course Delegate 2018

“Very well organised. The interactive workshops helped provide interaction and a change in pace from lectures and presentations. Very comfortable venue.”

Risk Benefit Course Delegate 2017

“Very useful and refreshing course. Covered the core concepts in a clear, concise manner.”

Risk Benefit Course Delegate 2017

“Well organised with clear and experienced speakers.”

Risk Benefit Course Delegate 2016

“Very useful course. Very friendly environment and variety of speakers with wide range of knowledge was a real bonus. Thank you!”

Risk Benefit Course Delegate 2015

Course Leader

Dr Miranda Davies – Senior Clinical Research Fellow, BM, MFPM

Miranda qualified from Southampton Medical School in 1995. She completed Senior House Officer Posts in a variety of hospital specialties (Psychiatry, Elderly Care, Obstetrics and Gynaecology, Palliative Medicine). Miranda joined the DSRU in 2002 as a Clinical Research Fellow.

Miranda has worked primarily on Modified-Prescription Event Monitoring (M-PEM) and Specialist Cohort Event Monitoring (SCEM) studies, providing medical support. In November 2002, she was appointed Honorary Senior Lecturer at the University of Portsmouth, and has presented at international conferences, and published papers in peer reviewed journals. She is actively involved in teaching, facilitating and course organisation through DSRU Education and Research Limited, and was appointed Senior Clinical Research Fellow in 2010. She holds the Diploma in Pharmaceutical Medicine, and is a Member of the Faculty of Pharmaceutical Medicine (MFPM) of the Royal College of Physicians.

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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