MAS Drug Discovery and Clinical Development 2025
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Date: Monday, 5 May 2025
Time: 10AM-11AM (CET)
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Information
Period
August 2025 - June 202760 ECTS credits
280 Teaching hours
606 hours of personal work; 500 hours of personal work for the MAS Thesis.
Language
EnglishFormat
On-siteRegistration
Registration deadline
15 June 2025Modules can be followed individually
Fees:
CHF 15鈥�500.- for the MAS
1-day module: CHF 1鈥�000.-
2-day module: CHF 1鈥�400.-
3-day module: CHF 1鈥�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 Product Development
- Principles and Methods聽of Clinical Research
- Ethical and Regulatory Aspects
- Non-Clinical Development and Clinical Pharmacology
- Safety Management聽and Drug Development
- Medical Statistics聽and Trials Methodologies
- Clinical Trial聽Planning and Set-Up part 1
- Clinical Trial聽Planning and Set-Up part 2
- Clinical Trials Conduct and Close out
- Audits and Inspections
- Regulatory Strategy in Product Development
- Chemistry Manufacturing and Controls or
- Clinical Development of anti-cancer and anti-infective vaccines
- Medical Devices
- New Perspectives in Product Development
Thesis
Director(s)
Prof. Youssef DAALI and 笔谤辞蹿.听Fran莽ois CURTIN, Faculty of Medecine,聽AV短视频
Coordinator(s)
Prof. Fran莽ois CURTIN and Dr Catherine SUAREZ, AV短视频
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庐 scandal: A case of shared responsibilities
Recherche clinique sur la COVID-19
L'int茅r锚t d'une recherche clinique de qualit茅, Prof. Gis猫le Pickering
Date(s)
25 August 2025
26 August 2025
27 August 2025
Fee
1800 CHF
Speakers
Dr Fran莽ois Curtin, Dr Emilie Alirol
Description
- Definition of product development: purpose, stakeholders, duration, cost and phases
- Success and failure in product development
- Fundamentals of health economics and regulatory framework
- Intellectual property in the context of medicines and medical devices
- Marketing strategies
- Target Product Profiles and Clinical Development Plans
Date(s)
22 September 2025
23 September 2025
24 September 2025
Fee
1800 CHF
Speakers
Dr Cyril Jaksic, Dr Ang猫le Gayet-Ageron
Description
- Development of research questions and choice of endpoints
- Overview of different study designs
- Fundamentals of statistical methods used in clinical research
- Principles of Randomized Controlled Trials (RCT)
- Critical review of publications
- Development of study protocols
- Sample size calculation
- Interim analysis planning
Date(s)
13 October 2025
14 October 2025
15 October 2025
Fee
1800 CHF
Speakers
Prof Samia Hurst, Dr Emilie Alirol, Dr Brigitte Happ
Description
- Fundamentals of clinical research ethics
- Informed consent process
- Purpose and function of research Ethics Committees (EC)
- Assessing risks and benefits to research participants
- Regulatory requirements聽 of trials investigating drugs, medical devices, and in vitro diagnostics
- Good clinical practices
- -Clinical trials authorizations
- Ethical issues in biobanks
Date(s)
3 November 2025
4 November 2025
5 November 2025
Fee
1800 CHF
Speakers
Dr Catherine Deloche,Prof. Youssef Daali,
Description
- Fundamentals 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 physiologically-based pharmacokinetics
- Early phases of clinical development
Date(s)
24 November 2025
25 November 2025
Fee
1400 CHF
Speakers
Dr Fran莽ois Curtin, Dr Fabiana Tirone
Description
- Risk management and safety monitoring during product development
- Safety assessment, documentation and reporting during clinical trials
- Pre-and post-marketing pharmacovigilance
- Role of Data and Safety Monitoring Boards (DSMB)
Date(s)
15 December 2025
16 December 2025
17 December 2025
18 December 2025
Fee
2200 CHF
Speakers
Dr Fran莽ois 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
Date(s)
19 January 2026
20 January 2026
21 January 2026
Fee
1800 CHF
Speakers
Dr Shelly Bustion, Dr Sandrine Charvat
Description
- Essentials of Clinical Trial Management
- Budget development and resource planning
- Investigator sites selection
- Role of CROs and external providers
- Clinical trial documents
- Submission to Ethics Committee (EC) and Regulatory Authorities (RA)
- Logistics planning: Investigational Products and other Clinical Trial supplies
Date(s)
9 February 2026
10 February 2026
11 February 2026
Fee
1800 CHF
Speakers
Dr Niloufar Marsousi, Dr Shelly Bustion
Description
- 聽Essentials of clinical trial monitoring
- Recruitment and retention of study subjects
- Data collection and data management
- Management of investigational product
- Documents and records
- Risk management
Date(s)
9 March 2026
10 March 2026
11 March 2026
Fee
1800 CHF
Speakers
Dr Isabelle Mercier, Dr Isabelle Semac
Description
- Quality management systems
- 听础耻诲颈迟
- Purpose and Conduct of regulatory inspections
- Site preparation to inspections
Planning
Dates to be confirmed
Date(s)
12 March 2026
Fee
1000 CHF
Speakers
Dr Lucie Bouchoud, Prof Farshid Sadeghipour, Dr Laurent Carrez
Description
- Explanation of the GMP (good manufacturing practice)
- Quality Assurance of the drug
- Qualification and Validation (premice, equipment)
- Raw material for drug manufacturing
- What can be manufactured by a hospital pharmacy for clinical trials?
Planning
Dates to be confirmed
Date(s)
12 March 2026
Fee
1000 CHF
Speakers
Prof Carole Bourquin, Dr Val茅rie Dutoit-Vallotton
Description
- Preclinical vaccine development and prerequisites for clinical trials
- Vaccine-relevant immunology: pathways to immunogenicity against infectious antigens and neoplastic cells
- Good Manufacturing Practice (GMP) in vaccine production
- Quality Assurance in vaccine production and testing
- Phases of clinical testing of anti-infective and anti-cancer vaccines
Planning
Dates to be confirmed
Date(s)
20 April 2026
21 April 2026
22 April 2026
Fee
1800 CHF
Speakers
Dr Brigitte Happ, Dr Enrica Alteri
Description
- Role and responsibilities of regulatory agencies
- International regulatory environment
- EU, Swiss, US legislation
- Early access to new therapeutic products
- Special populations (orphan, paediatrics)
- Advanced therapies
- Common Technical Document
- Generics and Biosimilars
- Regulatory strategies and health agencies interactions
Planning
Dates to be confirmed
Date(s)
11 May 2026
12 May 2026
Fee
1400 CHF
Speakers
Dr Mariagrazia Di Marco, Me Gabriel Avigdor
Description
- Overview of Medical devices (MD) development
- EU regulations (MDR, IVDR)
- Qualification and classification of MDs
- Clinical investigation and clinical trial application to authorities
- Market access strategy
- Materiovigilance
- Conformity assessment and CE marking
- Digital health and medical software
- Combination products
Planning
Dates to be confirmed
Date(s)
8 June 2026
9 June 2026
10 June 2026
Fee
1800 CHF
Speakers
Prof Youssef Daali, Dr Enrica Alteri
Description
- Personalized medicine scope and definition
- Omics and big data
- Use of data, analytics and Artificial Intelligence in product development
- Advanced Therapeutic Medicinal Products
- New therapeutic approaches being currently developed
Planning
Dates to be confirmed
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 AV短视频 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, 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, Dept 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 Pierre-Yves MARTIN, President, Catonal Commission on Human Research Ethics, Canton of Geneva
- 笔谤辞蹿.听, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, AV短视频
- Prof. Klara POSFAY BARBE, Medical Director, Geneva AV短视频 Hospitals
Scientific committee
- 顿谤听, Senior Director Clinical Affairs, FIND
- Dr , Pharmaceutical consultant, former Head of Human Medicine R&D Support Division EMA
- 笔谤辞蹿.听, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Z眉rich (ETH Z眉rich) & Lecturer at Hospitals of Geneva (UNIGE)
- Prof Youssef DAALI, Head of the Pharmacological Investigation Unit. Geneva AV短视频 Hospitals, Faculty of Medicine, AV短视频
- 顿谤听, Chief Operating Officer, Solid Drug Development,Geneva
- Prof Jules DESMEULES, Faculty of Medicine, AV短视频
- Prof. , Chief Medical Director of the Clinical Research (CRC), CHUV-UNIL, Lausanne
- Dr , Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva AV短视频 Hospitals, Faculty of Medecine, AV短视频
- Dr , Statistician, Methodological Support unit, Clinical Research Centre (CRC),聽Geneva AV短视频 Hospitals
- Dr , External Consultant
- Dr Fran莽oise LASCOMBES, External Consultant
- Dr , PhD, Lead Patient Engagement, Novartis, Basel
- 顿谤听, PharmD, Division of Clinical Pharmacology and Toxicology, AV短视频 Hospitals of Geneva and Faculty of Medicine, AV短视频
Application File
- Copy of identity document
- Passport photo (.jpg)
- Curriculum Vitae
- Copies of relevant university degrees
- Covering letter
- Two reference letters
- Written authorisation from employer, if applicable
- Signed registration form (PDF sent to you by email after your online registration)
Applications must be submitted by 15 June 2025. Admission decisions will be communicated latest in the first week of July. Starting date of the MAS: 25 Aug 2025 (Module 1)
Number of participants
Min. 10 participants
Detailed fees
15'500 CHF for the whole MAS programme.
Schedule
Generally between Monday and Thursday (approx. 8AM-6PM), depending on the module (most 3-day modules run from Monday to Wednesday).