Risk Benefit Assessment in Pharmacovigilance (Hybrid Event)

Course Overview

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, 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 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
• 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 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
• Formal and informal benefit-risk decision tools
• Risk benefit – a regulators perspective
• Practical implications of completing regulatory requirements
• Urgent re-evaluation of benefit-risk of a marketed product
• Benefit-risk assessment in Periodic Safety Reports – PBRERs and DSURs
• Communication of safety issues

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

• PMST

  £1040 + VAT

  Virtual

• PMST

  £1300 + VAT

  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

• 4 October 2023 - 5 October 2023

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  UK Based International

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