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Ethical Issues – SPRING 2021 (ENG)

25 Maggio 2021 / 8:00 - 17:00

The increasing knowledge in molecular biology and the development of the techniques for the evaluation of the biological processes and of their interaction have brought about, in preclinical and clinical research, what is called precision medicine, to select the treatment that works best for an individual.
The development of new therapeutic approaches raises many ethical issues, of which investigators’ also and in particular at the preclinical level, should be aware of and take into consideration in their decisions and activities.
The objectives of this course are to increase this awareness of the ethical issues and of their potential impact in the selection and preclinical evaluation of new molecules, in the decision making process, in the care of patients and in the social environment.
In particular,

  •  in the planning and modalities of activation of clinical studies;
  •  in the selection of treatment, relationship and care of patients;
  •  in the collection of data and biological tissues;
  •  in the analysis, report, publication and sharing of data and results;
  •  in the active involvement of patients already at the beginning of the clinical project;
  •  in the registration, selling and marketing of therapeutic compounds in Europe.

This course it is offered also as parts of the PhD degree programme of the Faculty of Biomedical Sciences, USI and it is structured as common course (General skills).
Duration 1 day = 0.5 ECTS

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  • 8:30

    Welcome and Introduction

    Prof. Dr. med. Dr phil. med. Alain Kaelin

  • 8:45

    Ethics in human research

    Dr. Susanne Driessen

    Content:

    1. Ethical principles, their application in biomedical research. And the role of ethics committees
    2. Ethical challenges: informed and general consent, personalized medicine, big data and artificial intelligence

  • 10:15

    Ethical issues in preclinical research (including animal experiments)

    Prof. Silvio Garattini

    Content:

    1. Animal experiments are necessary before any
    new chemical entities will be administered to
    humans.
    2. Ethical issues include the three R: reduction,
    refinement and replacement.
    3. The legislation should support animal
    experiments.

  • 11:00

    COFFEE BREAK

  • 11:15

    Ethical Issues in clinical research including COVID-19 pandemia

    Prof. Silvio Garattini

    Content:

    1. There is a need of comparative studies when
    more than one drug or vaccine is available.
    2. Drugs or vaccines must be compared with the
    best treatment available.
    3. Vaccination should be extended to all
    Countries.

  • 12:00

    The ethics of patient and public involvement (PPI) in academic clinical research

    Mrs. Cordula Landgraf

    Content:

    1. The concept of PPI
    2. Ethical considerations why patients and the public should be involved in academic clinical research
    3. Ethical principles in the performance of PPI

  • 12:45

    LUNCH BREAK

  • 13:45

    Ethical issues in the statistical analysis of clinical trials

    Dr. Valter Torri

    Content:

    Ethical implications of statistical planning and analysis in clinical experimentation, Focus on
    1. key statistical aspects of design (randomization, choice of control group, use of placebo, type of comparison)
    2. Statistical analysis (interim analysis, multiple tests, reporting of results).

  • 14:30

    Ethical issues in drug approval and marketing at the European level

    Dr. Rita Banzi

    Content:

    Overview of the role and responsibilities of the European Medicines Agency
    Ethical aspects in drug development and assessment (i.e., issues in pivotal trials and evaluation criteria)
    Ethical issues and accountability (i.e., financing, transparency and data sharing, communication and engagement with the public)

  • 15:15

    General discussion with all partecipants

  • 15:30

    Summary

Ethical Issues

May 25, 2021

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    The course fee is CHF 400.- EOC employees and CHF 650.- for external. Free for PhD students Faculty of Biomedical Sciences USI, ETH, USZ.
    After your registration you will receive an invoice.

    EOC employees who wish to be reimbursed from their service are kindly requested to apply (electronically) to EOFORM for authorization to participate.

    The fee, in case of cancellation announced less than 2 weeks before, must be fully payed.

    For PhD students registered in one of the PhD Programmes at the Faculty of Biomedical Sciences at USI, ETH and USZ, presenting a valid student card, there is no tuition fee to be covered.


    For more information:
    clinicaltrialunit@eoc.ch
    Laura Di Petto 091 811 7944

    Dettagli

    Data:
    25 Maggio 2021
    Ora:
    8:00 - 17:00
    Categoria Evento:

    Luogo

    Aula A2.08 Campus Est – USI Lugano
    USI Medicina Lugano
    Viganello, 6962 Svizzera