AV短视频

Health

Short course Management of Clinical Trials 鈥� Audits and Inspections 2025

Micro-credential

This Micro-credential Short Course Audits and Inspections corresponds to module 12 of the DAS in Management of Clinical Trials.

Microcertification

Information

Period

12 May 2025 - 14 May 2025
3 ECTS credits (micro-credential)
24 Teaching hours
Personal working hours: 66

EQF-level

Language

English

Format

On-site

Contact

Registration

Registration deadline

12 April 2025

Fees:

CHF 1,800

Contribution to the SDGs

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.

Director(s)

Prof. Youssef DAALI and Prof. Fran莽ois CURTIN, Faculty of Science and Faculty of Medicine, AV短视频

Coordinator(s)

Prof. Fran莽ois CURTIN, Dr Catherine SUAREZ and Ms Camille ARNI, AV短视频

Assessment

Multiple Choice Questions (MCQ)

Admission criteria

a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or聽a bachelor's degree in nursing from a Swiss AV短视频 of Applied Sciences;
or聽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)

Steering committee

  • Prof. Gerrit BORCHARD, President of the Section of Pharmaceutical Sciences (ISPSO), Faculty of Science, AV短视频
  • 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 AV短视频 Hospitals
  • Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
  • Prof. Antoine GEISSBUHLER, Dean of the Faculty of Medicine, AV短视频
  • Dr聽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, AV短视频
  • Prof. Arnaud PERRIER, Medical Director, Geneva AV短视频 Hospitals

Scientific committee

  • 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 Z眉rich & Lecturer at Geneva AV短视频 Hospitals, AV短视频
  • Prof. Youssef DAALI, Head of the Pharmacological Investigation Unit, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
  • Dr Patricia DELAITE, Chief Medical Officer, Nouscom, Basel
  • Dr Catherine DELOCHE, Chief Operating Officer, Solid Drug Development, Geneva
  • Prof. Jules DESMEULES, Faculty of Medicine, AV短视频
  • Prof. Philippe DUCOR, Faculty of Law, AV短视频
  • Prof. Marc FROISSART, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
  • Prof. Ang猫le GAYET-AGERON, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva AV短视频 Hospitals, Faculty of Medecine, AV短视频
  • Prof. Angela HUTTNER, Associate Professor, Department of Infectious Diseases, Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
  • Dr Cyril JAKSIC, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva AV短视频 Hospitals
  • Dr Fran莽oise LASCOMBES, External Consultant
  • Dr Guillaume PERRIARD, PhD, Lead patient Engagement, Novartis, Basel
  • Dr Victoria ROLLASON, Division of Clinical Pharmacology and Toxicology, Geneva AV短视频 Hospitals and Faculty of Medicine, AV短视频

Application File

  • Copy of identity document
  • Passport photo (jpg format following these guidelines )
  • Curriculum Vitae
  • Copies of relevant university degrees
  • Covering letter
  • Dr Isabelle MERCIER
  • Dr Isabelle SEMAC

Contribution to the SDGs

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