Micro-credential

This Micro-credential Short Course Medical Statistical and Trial Methodologies corresponds to module 6 of the MAS Drug Discovery and Clinical Development

Overview

Objectives

  • Acquire foundational knowledge of statistical principles applied to clinical research and drug development
  • Understand and apply key concepts such as distributions, estimators, and statistical power in the context of medical research
  • Explore various clinical trial designs, including parallel, cross-over, sequential, and adaptive designs
  • Learn to develop and critically review clinical study protocols
  • Gain insight into pharmaco-epidemiological methods and their relevance to real-world data and post-marketing studies
  • Understand the application of ICH E9 guidelines on statistical principles in clinical trials

Audience

Professionals involved in clinical research, regulatory affairs, biostatistics, or medical writing within the healthcare and pharmaceutical industries. This includes clinical trial managers, biostatisticians, medical advisors, regulatory scientists, and professionals engaged in the design, analysis, and interpretation of clinical studies.

Learning outcomes

  • Ability to apply statistical methods to design, analyse, and interpret clinical trial data
  • Proficiency in selecting appropriate trial designs to meet specific research objectives
  • Skill in drafting and reviewing clinical study protocols with a sound statistical foundation
  • Understanding of pharmaco-epidemiological approaches for assessing drug safety and effectiveness in large populations
  • Knowledge of regulatory expectations related to statistical methodology in clinical trials, including ICH E9 compliance

Registration

Registration deadline

15 November 2025

Fees:

CHF 2,200

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 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)

Application File

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

Curriculum

Period

15 December 2025 - 18 December 2025

Teaching hours

32 teaching hours

Microcertification

5 ECTS credits
EQF-level: 7

Director(s)

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

Coordinator(s)

Prof. François CURTIN and Dr Catherine SUAREZ, University of Geneva

Steering committee

  • Prof. Gerrit BORCHARD, President of the Section of Pharmaceutical Sciences (ISPOS), 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, Dept 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 Samia HURST, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, University of Geneva
  • Dr Pierre-Yves MARTIN, President, Catonal Commission on Human Research Ethics, Canton of Geneva
  • Prof Klara POSFAY BARBE, Medical Director, Geneva University 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, Head of the Centre for Clinical Research, Lucerne Cantonal Hospital (LUKS), 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 Catherine DELOCHE, Chief Operating Officer, Solid Drug Development,Geneva
  • Prof Jules DESMEULES, Faculty of Medicine, University of Geneva
  • Prof Marc FROISSART, Chief Medical Director of the Clinical Research (CRC), CHUV-UNIL, Lausanne
  • Dr Angèle GAYET-AGERON, Full Professor in Epidemiology and Public Health & Director of the Institute of Social and Preventive Medicine (ISPM) at University of Bern
  • Dr Brigitte HAPP, External Consultant
  • 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, PharmD, Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva and Faculty of Medicine, University of Geneva

Related programmes

FAQ