MAS Drug Discovery and Clinical Development 2022

This MAS is aimed at professionals from academia, the pharmaceutical industry, biotechnology sector, and international organizations who wish to gain an in-depth understanding of drugs and medical devices research and development.

Information

Period

Contact coordinator
60 ECTS credits
280 Teaching hours
Every 2 years

Language

English

Format

On-site – switch over to online-learning if required

Contact

Location

Geneva

Registration

Contact coordinator
Modules can be followed individually

Fees:

CHF 13’000.- for the Master
CHF 1’500.- for individual modules

Contribution to the SDGs

Goal 3: Ensure healthy lives and promote well-being for all at all ages Goal 9: Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation Goal 16: Promote peaceful and inclusive societies for sustainable development

Objectives

  • Provide essential business knowledge of drug and medical devices in clinical research and development
  • Give health professionals the tools to comply with the highest scientific and ethical standards in clinical research
  • Empower physicians and health scientists to lead clinical trials within hospitals, pharmaceutical and biotechnology companies
  • Enable health professionals to gain a strategic vision of clinical development and navigate the complexities of bringing new medicinal products to the global market

Audience

Medical doctor, biologist, pharmacist, nurse, biochemist and other professional involved or wishing to gain skills and knowledge, in the field of drug discovery and development

Learning outcomes

  • Understand the stakes, challenges and opportunities of drug discovery and development
  • Master the fundamental scientific and ethical principles of drug discovery and development
  • Gain knowledge of Good Clinical Practices (GCP) and of clinical research regulations in Switzerland, Europe and the United States
  • Learn how to navigate clinical trial authorization and marketing authorization processes
  • Master effective planning and management for clinical trials
  • Successfully manage partnerships with pharmaceutical and biotechnology partners
  • Understand the issues related to research subject protection
  • Understand and take up the challenges of new technologies and personalized medicine

Programme

13 modules:

  • Introduction to Clinical Development: Challenges and Prospects
  • Principles and Methods of Clinical Research
  • Ethical and Legal Aspects
  • Preclinical Pharmacology, Toxicology and Clinical Pharmacology
  • Safety Management and Drug Development
  • Medical Statistics and Trial Methodologies
  • Clinical Trials Set-up and Conduct part 1
  • Clinical Trials Set-up and Conduct part 2
  • Regulatory Considerations in Drug Development
  • Clinical Trials Close-out and Reporting
  • Medical Devices
  • Audits and Inspections
  • New Perspectives, Personalized Medicine and New Therapeutics

Thesis

Director(s)

Prof. Jules DESMEULES, Faculty of Medecine and Faculty of Science, Dr François CURTIN, Faculty of Medecine, University of Geneva

Coordinator(s)

Dr François CURTIN, University of Geneva, Dr Catherine DELOCHE, Solid Drug Development et Dr Françoise LASCOMBES, External consultant

Accreditation

This programme is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals, Swiss Society of Clinical Pharmacology and Toxicology, Swiss Institute for postgraduate and continuous medical education
The Mediator® scandal: A case of shared responsibilities
Recherche clinique sur la COVID-19

Date(s)

22 March 2018

Fee

1500 CHF

Speakers

Dr François Curtin, Dr Emilie Alirol

Description

  • Definition of pharmaceutical development: purpose, players and phases
  • Success and failure in drug discovery and development
  • Fundamentals of health economics
  • Intellectual property
  • Marketing strategies in drug development
  • Alternative models of drug development: product development partnerships and not-for-profit entities

Fee

1500 CHF

Speakers

Dr François Curtin, Dr Angèle Gayet-Ageron

Description

  • Development of research questions and choice of endpoints
  • Study designs
  • Statistical methods used in clinical research
  • Principles of Randomized Controlled Trials (RCT)
  • Critical review of publications
  • Development of study protocols
  • Choice of endpoints
  • Sample size calculation
  • Interim analysis planning

Fee

1500 CHF

Speakers

Prof. Samia Hurst, Prof. Philippe Ducor, Dr Brigitte Happ

Description

  • Clinical research ethics
  • Informed consent process
  • Data protection and confidentiality
  • Purpose and function of research Ethics Committees (EC)
  • Assessing risks and benefits to research participants
  • Vulnerable populations
  • Good clinical practices
  • Legal framework applicable in Switzerland, Europe and the United States for drugs, medical device and non-interventional trials
  • ClinicalTrial Agreements (CTA) and authorship issues
  • Ethical issues in biobanks

Fee

1500 CHF

Speakers

Prof. Gerrit Borchard, Prof. Youssef Daali, Dr Catherine Deloche, Dr Marie Besson

Description

  • Basics of pharmacology
  • Safety assessment in pre-clinical research
  • Drug metabolism
  • Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)
  • Preclinical development for specific indications and type of products
  • Population physiologicaly-based pharmacokinetics
  • Early phases of clinical development

Fee

1500 CHF

Speakers

Dr Victoria Rollason, Dr François Curtin, Prof. Jules Desmeules

Description

  • Risk management and safety monitoring during drug development
  • Safety assessment, documentation and reporting during clinical trials
  • Pre-and post-marketing pharmacovigilance
  • Role of Data and Safety Monitoring Boards (DSMB)

Fee

1500 CHF

Speakers

Dr François Curtin, Dr David W Warne

Description

  • Statistical principles for drug development: ICH E9
  • Distributions
  • Parameters estimators
  • Power calculations
  • Clinical trials designs: parallel, cross-over, sequential, and adaptive designs
  • Development of study protocols
  • Pharmaco-epidemiology

Fee

1500 CHF

Speakers

Dr Mariagrazia Di Marco, Dr Sandrine Charvat

Description

  • Scientific, strategic and safety considerations in clinical trial design
  • Budget development and resource planning
  • Investigator sites selection
  • Role of CROs and external providers
  • Clinical trial documents
  • Standard Operation Procedures (SOP)
  • Submission to Swiss Ethics Committee (EC) and Swiss Regulatory Authorities (RA)

Fee

1500 CHF

Speakers

Ms Jennifer Kealy, Ms Virginie Vidal

Description

  • Project management applied to clinical trials
  • Recruitment and retention of study subjects
  • Management of randomization and blinding systems
  • Data collection and data management
  • Management of investigational medicinal product
  • Documents and records
  • Monitoring of clinical studies
  • Root-cause analysis

Fee

1500 CHF

Speakers

Dr Brigitte Happ, Ms Marion Laumonier

Description

  • Role and responsibilities of regulatory agencies
  • International regulatory environment
  • EU, Swiss,US Legislation
  • Early access to new therapeutic products
  • Life-cycle management
  • Special populations (orphan, paediatrics)
  • Antibiotic development
  • Advanced therapies
  • In vitro companion diagnostics
  • Regulatory strategies and health agencies interactions

Fee

1500 CHF

Speakers

Me Gabriel Avigdor, Dr Mariagrazia Di Marco

Description

  • Clinical trial close-out activities
  • Data cleaning and database lock
  • Statistical Analysis Plan (SAP) and result reporting
  • Medical writing and clinical study report
  • Safety reconciliation and MedDRA coding
  • Medical devices and clinical requirements under MDR/IVDR
  • Clinical investigation of medical devices and submissions to authorities
  • Regulatory aspects of digital health and medical software
  • Medical device vigilance

Fee

1500 CHF

Speakers

Dr Isabelle Mercier, Dr Isabelle Semac

Description

  • Quality management systems
  • Audit
  • Purpose and conduct of regulatory inspections
  • Site preparation to inspections

Fee

1500 CHF

Speakers

Prof. Caroline Samer, Dr Patricia Delaite

Description

  • Personalized medicine scope and definition
  • Omics and big data
  • New requirements in drug development
  • New tools and technologies enabling key patient benefit
  • New therapeutic approaches being currently developed

Pedagogical method

Lectures, interactive seminars, workshops, vocational training. Teaching is in English or in French.

Admission criteria

  • Title of physician
  • Or master's or bachelor's degree in Life Science or title deemed equivalent
  • Or Bachelor's degree from a Swiss University of Applied Science plus a minimum of 1 year professionnal experience in clinical development
  • Good understanding of both French (knowledge equivalent to B2 Level) and English (knowledge equivalent to the Cambridge First Certificate)

Steering committee

  • Prof. Cem Gabay, Dean of the Faculty of Medicine, University of Geneva
  • Prof. Arnaud Perrier, Medical Director, University Hospitals of Geneva
  • Prof. Gerrit Borchard, Head of Biopharmaceutics, Section of Pharmaceutical Sciences, Faculty of Science, University of Geneva
  • Dr Angèle Gayet-Ageron, CC, Lecturer, Head of the Methodological Support Unit, Clinical Research Centre (CRC), University Hospitals of Geneva, Faculty of Medecine, University of Geneva
  • Prof. Bernard Hirschel, 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. Jérôme Pugin, Vice-Dean of the Faculty of Medicine and President of the Clinical Research Center (CRC), University Hospitals of Geneva, Faculty of Medicine, University of Geneva

Scientific committee

  • Dr Emilie Alirol, Project Leader, Global Antibiotics Research and Development Partnership (GARDP), Drugs for Neglected Diseases initiative (DNDi)
  • Dr Vanya Beltrami, Vice-President, Head of Manufacturing, Anergis, Lausanne
  • Dr Jocelyne Chabert, Clinical Research Associate, Clinical Research Centre (CRC), University Hospitals of Geneva, Faculty of Medicine, University of Geneva
  • Dr Francois Curtin, PD, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Zürich (ETH Zürich) & Lecturer at Hospitals of Geneva (UNIGE)
  • Dr Patricia Delaite, Medical Director,Geneva
  • Dr Catherine Deloche, Chief Operating Officer, Solid Drug Development,Geneva
  • Prof. Philippe Ducor, Faculty of Law, University of Geneva
  • Prof. Marc Froissart, Chief Medical Director of the Clinical Research (CRC), CHUV-UNIL, Lausanne
  • Dr Angèle Gayet-Ageron, CC, Lecturer, Head of the Methodological Support Unit, Clinical Research Centre (CRC), University Hospitals of Geneva, Faculty of Medecine, University of Geneva
  • Dr Françoise Lascombes, External Consultant
  • Prof. Hervé Porchet, Pharmaceutical consultant
  • Dr Victoria Rollason, PharmD, Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva and Faculty of Medicine, University of Geneva
  • Dr Gabriele Ackermann, Chief Scientific Officer ad interim, Therapeutic Area Head Cardiovascular, Renal & Metabolism Therapeutic Area Head Respiratory, Novartis Pharma Switzerland

Number of participants

Le nombre de participant-es est adapté à la pédagogie choisie.

Contribution to the SDGs

Goal 3: Ensure healthy lives and promote well-being for all at all ages Goal 9: Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation Goal 16: Promote peaceful and inclusive societies for sustainable development

Les termes utilisés pour désigner des personnes sont pris au sens générique; ils ont à la fois la valeur d'un masculin et d'un féminin.