Introduzione

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

Docente/i
Francesco Tescione
Info

Francesco Tescione

European Qualified Person Responsible for Pharmacovigilance at L. Molteni & C.
Francesco Tescione, European Qualified Person Responsible for Pharmacovigilance - L. Molteni & C. dei F.lli Alitti, he is responsible for the pharmacovigilance system, by coordinating all relevant aspects, including quality and risk management. He graduated in Pharmacy from the University of Salerno and gained a 2nd degree Master in Clinical Epidemiology and Guidelines from the University of Florence and held the position of Eu-QPPV for more than 10 years, many of which spent abroad. He has published several papers in international journals dealing, among others, with topics such as predictability- preventability of adverse reactions and methods for the determination of causality.  He has been a speaker at several training events on different aspects of 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.

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Versione Stampabile
Cosa saprai fare dopo il corso
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