Management of Clinical Trials - Audits and Inspections (2025)

Micro-credential

The micro-credentialed Short course Audits and Inspections corresponds to module 12 of the DAS in Management of Clinical Trials.

• Gain a comprehensive understanding of quality management systems in healthcare settings.
• Develop proficiency in conducting audits to assess compliance with regulatory standards and internal policies.
• Understand the purpose and conduct of regulatory inspections by health authorities.
• Learn strategies for preparing sites and stakeholders for regulatory inspections.
• Identify best practices for responding to observations and findings from regulatory inspections.

Professionals involved in quality management systems, audits, and regulatory compliance within the healthcare industry, including quality assurance managers, regulatory affairs specialists, compliance officers, and individuals responsible for preparing sites for regulatory inspections.

• Proficiency in implementing and maintaining quality management systems in healthcare environments.
• Ability to plan, execute, and document audits effectively to assess compliance with regulatory standards.
• Understanding of the objectives and procedures of regulatory inspections and their implications for healthcare organizations.
• Skill in conducting site preparations for regulatory inspections, including ensuring compliance with applicable regulations and standards.

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva

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 University 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)

• Prof. Gerrit Borchard, President of the Section of Pharmaceutical Sciences (ISPSO), Faculty of Science, University of Geneva
• Prof. Alexandra Calmy, Vice-Dean of clinical research, Director of the Clinical Research Centre (CRC), Head of HIV/AIDS Unit, Associate Physician, Department of Infectious Diseases, Geneva University Hospitals
• Prof. Youssef Daali, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Prof. Antoine Geissbuhler, Dean of the Faculty of Medicine, University of Geneva
• Dr Olivier Huber, President, Cantonal Commission on Human Research Ethics, Canton of Geneva
• Prof. Samia Hurst, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, University of Geneva
• Prof. Arnaud Perrier, Medical Director, Geneva University Hospitals

• Dr Emilie Alirol, Senior Director Clinical Affairs, FIND
• Dr Enrica Alteri, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division, EMA
• Prof. Francois Curtin, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Zürich & Lecturer at Geneva University Hospitals, University of Geneva
• Prof. Youssef Daali, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Dr Patricia Delaite, Chief Medical Officer, Nouscom, Basel
• Dr Catherine Deloche, Chief Operating Officer, Solid Drug Development, Geneva
• Prof. Jules Desmeules, Faculty of Medicine, University of Geneva
• Prof. Philippe Ducor, Faculty of Law, University of Geneva
• Prof. Marc Froissart, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
• Prof. Angèle Gayet-Ageron, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals, Faculty of Medecine, University of Geneva
• Prof. Angela Huttner, Associate Professor, Department of Infectious Diseases, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Dr Cyril Jaksic, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals
• Dr Françoise Lascombes, External Consultant
• Dr Guillaume Perriard, PhD, Lead patient Engagement, Novartis, Basel
• Dr Victoria Rollason, Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, University of Geneva

• Copy of identity document
• Passport photo
• Curriculum Vitae
• Copies of relevant university degrees
• Covering letter
• Two reference letters
• Written authorisation from their employer, if applicable