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
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
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
Teaching hours
Microcertification
Assessment
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)
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
Related programmes
- DAS - Management of Clinical Trials (2024)
- Session - Management of Clinical Trials – Ethical and Legal Aspects (2024)
- Session - Management of Clinical Trials – Clinical Trials Set-up and Conduct (2025)
- Session - Management of Clinical Trials – Clinical Trials Conduct and Close-out (2025)
- Session - Management of Clinical Trials – Medical Devices (2025)