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
Francesco is responsible for the pharmacovigilance system through the coordination of all pertinent aspects, including quality and risk management. With a background in Pharmacy and a Master’s in Clinical Epidemiology and Guidelines, he has served as Eu-QPPV for about 20 years. He has published several papers in international journals on topics such as the predictability-avoid ability of adverse reactions and methods for determining the causal association. He has been a speaker at several training events on various aspects of Eudravigilance, 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
Printable Version
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.