About

The EU regulations and GVPs require MAHs to continuously monitor the benefits and risks of their medicines, whether authorised or under clinical investigation. The Benefit-Risk assessment is a process which involves various activities requiring pharmacovigilance experience and expertise.

Complying with the requirements for a critical integrated benefit risk evaluation can be a challenging exercise for any pharmacovigilance department. Furthermore, the perspective of different stakeholders (regulator, marketing authorisation holder, patient, or prescriber) may vary.

The objective of this course is to provide knowledge and understanding of the concepts and principles of Benefit-Risk assessment and lead to the critical analysis of data sources for the evaluation of risks. The course will show both qualitative and basic quantitative methods for Benefit-Risk assessment, including their practical application in decision making. Specific attention is given to the motivations and background of the different stakeholders, as well as the actions for minimising risks with medicines.

During the 2-module training, the following topics will be covered

  • Risk definition and measurement
  • Measures of association
  • Identification and evaluation of risk
    • Internal/external data sources
    • Evaluation of a signal
    • Prioritisation of risk
    • Causality assessment
  • Formal and informal benefit-risk decision tools
  • Example of Benefit-Risk Action Team (BRAT) methodology
  • Taking action
    • Minimising risks with medicines
    • Regulatory actions
    • Risk Management Plans
  • Practical implications and regulatory requirements
  • Benefit-risk assessment in Periodic Safety Update Reports

Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, regulatory affairs.

 

Participant’s experience

Knowledge of the relevant GVP guidelines (Module I, VI, V and IX) and at least 2 years’ experience in pharmacovigilance are suggested.

Interactive training

Lecturers
Francesco Tescione
Info

Francesco Tescione

European Qualified Person Responsible for Pharmacovigilance at L. Molteni & C.

Francesco Tescione, European Qualified Person Responsible for Pharmacovigilance at L. Molteni & C. dei F.lli Alitti, brings over a decade of experience in coordinating pharmacovigilance systems, quality, and risk management. With a background in Pharmacy and a Master’s in Clinical Epidemiology and Guidelines, Francesco has served as Eu-QPPV for more than 10 years, contributing to international journals and training events on EVDAS and Signal Management

Online Training – 2 modules

MODULE 1 | 13 December 2022 from 9 am to 1 pm CET
MODULE 2 | 15 December 2022 from 9 am to 1 pm CET

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 880,00* (until 25 October 2022)

Ordinary: € 1.070,00*

Freelance – Academy – Public Administration**: € 572,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register

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Printable Version
At the end of the training, you will be able to
Risultato atteso
Critically analyse the data sources associated with risks
Risultato atteso
Undertake a risk benefit analysis of a medicinal product
Risultato atteso
Outline strategies for optimising the benefit-risk balance
Risultato atteso
Understand current regulatory legislation and guidelines relevant to risk management
<p>Online interactive training on Zoom platform.</p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

<p>Online interactive training on Zoom platform.</p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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Benefit Risk Assessment in Pharmacovigilance