Micro-credential

This Micro-credential Short Course Audits and Inspections corresponds to module 9 of the DAS in Management of Clinical Trials.

Overview

Objectives

  • 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.

Audience

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.

Learning outcomes

  • 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.

Registration

Registration deadline

12 April 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 ÓñÃÀÈË´«Ã½ 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

9 March 2026 - 11 March 2026

Teaching hours

24 teaching hours

Microcertification

3 ECTS credits
: 7

Assessment

Multiple Choice Questions (MCQ)

Intervenant-es

  • Dr Isabelle MERCIER
  • Dr Isabelle SEMAC

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, ÓñÃÀÈË´«Ã½

Coordinator(s)

Prof. François CURTIN, Dr Catherine SUAREZ and Ms Camille ARNI, ÓñÃÀÈË´«Ã½

Steering committee

  • Prof. , President of the Section of Pharmaceutical Sciences (ISPOS), Faculty of Science, ÓñÃÀÈË´«Ã½
  • 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 ÓñÃÀÈË´«Ã½ Hospitals
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva ÓñÃÀÈË´«Ã½ Hospitals, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • Prof , Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • Dr , President, Catonal Commission on Human Research Ethics, Canton of Geneva
  • Prof Klara POSFAY BARBE, Medical Director, Geneva ÓñÃÀÈË´«Ã½ 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 ÓñÃÀÈË´«Ã½ Hospitals, ÓñÃÀÈË´«Ã½
  • Prof Youssef DAALI, Head of the Pharmacological Investigation Unit. Geneva ÓñÃÀÈË´«Ã½ Hospitals, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • ¶Ù°ùÌý, Chief Operating Officer, Solid Drug Development,Geneva
  • Prof Jules DESMEULES, Faculty of Medicine, ÓñÃÀÈË´«Ã½
  • 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 ÓñÃÀÈË´«Ã½ of Bern
  • Dr , External Consultant
  • Dr , Statistician, Methodological Support unit, Clinical Research Centre (CRC), Geneva ÓñÃÀÈË´«Ã½ Hospitals
  • Dr , External Consultant
  • Dr , PhD, Lead Patient Engagement, Novartis, Basel
  • ¶Ù°ùÌý, PharmD, Division of Clinical Pharmacology and Toxicology, ÓñÃÀÈË´«Ã½ Hospitals of Geneva and Faculty of Medicine, ÓñÃÀÈË´«Ã½

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