Micro-credential

This Micro-credential Short Course Ethical and Regulatory Aspects corresponds to module 3 of the DAS in Management of Clinical Trials.

Overview

Objectives

  • Understand the principles of Human Subject research ethics.
  • Demonstrate knowledge of the informed consent process.
  • Recognise the importance of data protection and confidentiality in clinical studies.
  • Explain the purpose and function of Research Ethics Committees (EC).
  • Evaluate risks and benefits associated with research participation.
  • Identify and address ethical considerations for vulnerable populations in clinical trials.
  • Apply principles of Good Clinical Practice (GCP) in clinical trial management.
  • Familiarise with the legal frameworks governing Human Subject Research, including interventional studies with investigational medicinal products and medical devices, in Switzerland, Europe, and the United States.
  • Familiarise ethical issues related to biobanks in clinical research.

Audience

Healthcare professionals, researchers, and individuals involved in Human Subject Research, including clinical trial managers, coordinators, monitors, scientists, and regulatory affairs specialists.

Learning outcomes

  • Ethical decision-making in clinical research and clinical trial management.
  • Compliance with regulatory requirements and Good Clinical Practice standards.
  • Effective communication with stakeholders regarding ethical considerations.
  • Understanding of regulatory framework and processes.
  • Critical thinking and problem-solving in addressing ethical dilemmas in biobanking and clinical research.

Registration

Registration deadline

1 September 2025

Fees:

CHF 1,800

Admission criteria

a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor's degree in nursing from a Swiss AV¶ÌÊÓÆµ of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.

b) Good oral and written comprehension of English (equivalent to level B2-C1)

Application File

  • Copy of identity document
  • Curriculum Vitae
  • Copies of relevant university degrees
  • Covering letter

Curriculum

Period

13 October 2025 - 15 October 2025

Teaching hours

24 teaching hours

Microcertification

2 ECTS credits
: 7

Assessment

Multiple Choice Questions (MCQ)

Intervenant-es

  • Prof. Samia HURST
  • Dr Emilie ALIROL
  • Dr Brigitte HAPP

Partnerships / Collaboration

Accreditation / Recognition / Certification

The course is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals (SwAPP), Swiss Society of Clinical Pharmacology and Toxicology (SGKPT-SSPTC), Swiss Institute for postgraduate and continuous medical education (SWIF-ISFM).

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, AV¶ÌÊÓÆµ

Coordinator(s)

Prof. François CURTIN, Dr Catherine SUAREZ and Ms Camille ARNI, AV¶ÌÊÓÆµ

Steering committee

  • Prof. , President of the Section of Pharmaceutical Sciences (ISPOS), Faculty of Science, AV¶ÌÊÓÆµ
  • Prof Alexandra CALMY, Vice-Dean of clinical research, Director of the Clinical Research Centre (CRC), Head of HIV/AIDS Unit, Associate Physician, Dept of Infectious Diseases, Geneva AV¶ÌÊÓÆµ Hospitals
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV¶ÌÊÓÆµ Hospitals, Faculty of Medicine, AV¶ÌÊÓÆµ
  • Prof , Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, AV¶ÌÊÓÆµ
  • Dr , President, Catonal Commission on Human Research Ethics, Canton of Geneva
  • Prof Klara POSFAY BARBE, Medical Director, Geneva AV¶ÌÊÓÆµ Hospitals

Scientific committee

  • ¶Ù°ùÌý, Senior Director Clinical Affairs, FIND
  • Dr , Pharmaceutical consultant, former Head of Human Medicine R&D Support Division EMA
  • ±Ê°ù´Ç´Ú.Ìý, Head of the Centre for Clinical Research, Lucerne Cantonal Hospital (LUKS), Lecturer at Geneva AV¶ÌÊÓÆµ Hospitals, AV¶ÌÊÓÆµ
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit. Geneva AV¶ÌÊÓÆµ Hospitals, Faculty of Medicine, AV¶ÌÊÓÆµ
  • ¶Ù°ùÌý, Chief Operating Officer, Solid Drug Development,Geneva
  • Prof Jules DESMEULES, Faculty of Medicine, AV¶ÌÊÓÆµ
  • Prof , Chief Medical Director of the Clinical Research (CRC), CHUV-UNIL, Lausanne
  • Dr , Full Professor in Epidemiology and Public Health & Director of the Institute of Social and Preventive Medicine (ISPM) at AV¶ÌÊÓÆµ of Bern
  • Dr , External Consultant
  • Dr , Statistician, Methodological Support unit, Clinical Research Centre (CRC), Geneva AV¶ÌÊÓÆµ Hospitals
  • Dr , External Consultant
  • Dr , PhD, Lead Patient Engagement, Novartis, Basel
  • ¶Ù°ùÌý, PharmD, Division of Clinical Pharmacology and Toxicology, AV¶ÌÊÓÆµ Hospitals of Geneva and Faculty of Medicine, AV¶ÌÊÓÆµ

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