MAS Drug Discovery and Clinical Development 2025
Announcement: MAS Programme scheduled to 2025/26 - registrations open from Spring 2025
The Master of Advanced Studies (MAS) program will be rescheduled to the 2025/26 academic year for curriculum improvements.
Information
Period
Contact coordinator60 ECTS credits
289 Teaching hours
606 hours of personal work; 900 hours of personal work for the MAS Thesis.
Language
EnglishFormat
On-site – switch over to online-learning if requiredRegistration
Contact coordinator
Modules can be followed individually
Fees:
CHF 15’500.- for the MAS
1-day module: CHF 1’000.-
2-day module: CHF 1’400.-
3-day module: CHF 1’800.-
Contribution to the SDGs
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, veterinarians, 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 Statistical and Trials 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. Youssef DAALI and Prof. François CURTIN, Faculty of Medecine, University of Geneva
Coordinator(s)
Prof. François CURTIN and Dr Catherine SUAREZ, University of Geneva
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
L'intérêt d'une recherche clinique de qualité, Prof. Gisèle Pickering
Fee
1800 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
1800 CHF
Speakers
Dr Cyril Jaksic, 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
1800 CHF
Speakers
Prof Samia Hurst, Dr Emilie Alirol, 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
1800 CHF
Speakers
Dr Catherine Deloche, Dr Valérie Nicolas, Dr Marie-Paule Simonin, Prof. Gerrit Borchard, Prof. Youssef Daali, 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
1400 CHF
Speakers
Dr François Curtin, Dr Fabiana Tirone
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
1800 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
1800 CHF
Speakers
Dr Shelly Bustion, 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
1800 CHF
Speakers
Dr Niloufar Marsousi, Dr Cécile Nicolas Denizou
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
1800 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
1000 CHF
Speakers
Dr Lucie Bouchoud, Prof Farshid Sadeghipour, Dr Laurent Carrez
Description
- Explanation of the GMP
- Quality Assurance if the drug
- Qualification and Validation (premise, equipment)
- Raw material for drug manufacturing
- What can be manufactured by a hospital pharmacy for clinical trials?
Fee
1000 CHF
Speakers
Prof Carole Bourquin, Dr Valérie Dutoit-Vallotton
Description
- Preclinical vaccine development and prerequisites for clinical trials
- Vaccine relevant immunology: pathways to immunogenicity agains infectious antigens and neoplastic cells
- GMP in vaccine production
- Quality Assurance in vaccine production and testing
- Phases of clinical testing of anti-infective and anti-cancer vaccines
Fee
1400 CHF
Speakers
Dr Mariagrazia Di Marco, Me Gabriel Avigdor
Description
- Medical devices (MD) and new EU regulations (MDR, IVDR)
- Qualification and classification
- Clinical investigation and clinical trial application
- to authorities
- Market access strategy
- Materiovigilance
- Conformity assessment and CE marking
- Digital health and medical software
- Combination products
Fee
1800 CHF
Speakers
Dr Isabelle Mercier, Dr Isabelle Semac
Description
- Quality management systems
- Audit
- Purpose and Conduct of regulatory inspections
- Site preparation to inspections
Fee
1800 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.
This MAS is aimed at professionals from academia, pharmaceutical industry, biotechnology sector, and international organisations who wish to gain in-depth understanding of drugs and medical devices in clinical research and development.
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 English (B2-C1 level)
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 Antoine GEISSBUHLER, Dean of the Faculty of Medicine, University of Geneva
- Dr Olivier Huber, President, Catonal 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. Arnaud PERRIER, Medical Director, Geneva University Hospitals
Scientific committee
- Dr Emilie ALIROL, Project Leader, Global Antibiotics Research and Development Partnership (GARDP), Drugs for Neglected Diseases initiative (DNDi)
- 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 Zürich (ETH Zürich) & Lecturer at Hospitals of Geneva (UNIGE)
- Prof Youssef DAALI, Head of the Pharmacological Investigation Unit. Geneva University Hospitals, Faculty of Medicine, University of Geneva
- Dr Patricia DELAITE, Chief Medical Officer, Nouscom, Basel
- Dr Catherine DELOCHE, Chief Operating Officer, Solid Drug Development,Geneva
- Prof Jules DESMEULES, Faculty of Medicine, University of 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