MAS Drug Discovery and Clinical Development: Join Our Last Online Information Session!
Interested in our MAS or DAS programmes? Join us for our last live session to ask questions, and meet us!
Date: Friday, 13 June 2025
Time: 10AM-11AM (CET)
Location: Online on this Zoom link
No registration required—just drop in! We look forward to seeing you there!
If you cannot connect on Friday and have a question, feel free to call us on this line +41 22 379 69 33.
Overview
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: Challenges and Prospects
- Principles and Methods of Clinical Research
- Ethical and Regulatory Aspects
- Non-Clinical Development and Clinical Pharmacology
- Safety Management During Drug Development
- Medical Statistics and Trial Methodologies
- Clinical Trial Planning and Set-Up
- Clinical Trial Conduct and Close out
- Audits and Inspections
- Chemistry Manufacturing and Controls or
- Clinical Development of Anti-Cancer and Anti-Infective vaccines
- Regulatory Strategy in Product Development
- Medical Devices
- New Perspectives in Product Development
Thesis
Registration
Registration deadline
22 June 2025
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.-
- 4-day module: CHF 2'200.-
Admission criteria
- Medical degree (physician title), or
- Master’s or Bachelor’s degree in Life Sciences or an equivalent qualification, or
- Bachelor’s degree from a Swiss University of Applied Sciences plus at least one year of relevant professional experience
- Good command of English (level B2–C1)
Candidates attending the programme during working hours must provide written authorisation from their employer.
Number of participants
Min. 10 participants
Application File
- Copy of identity document
- Curriculum Vitae
- Copies of relevant university degrees
- Covering letter
- Two reference letters
- Written authorisation from employer, if applicable
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)
Cancellation Policy
Any withdrawal before the start of the programme will incur an administration fee of CHF 500.-. Fees will be payable in full once the course has begun.
Curriculum
Period
August 2025 - June 2026
Credits
60 ECTS credits
Teaching hours
288 teaching hours
Schedule
Generally between Monday and Wednesday (approx. 8AM-6PM), depending on the module.
Date(s)
25 August 2025
26 August 2025
27 August 2025
Fee
1800 CHF
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
Speakers
Dr François Curtin, Dr Emilie Alirol
Date(s)
22 September 2025
23 September 2025
24 September 2025
Fee
1800 CHF
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
Speakers
Dr Cyril Jaksic, Dr Maël Barthoulot
Date(s)
13 October 2025
14 October 2025
15 October 2025
Fee
1800 CHF
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 of trials investigating drugs, medical devices, and in vitro diagnostics
- Good clinical practices
- -Clinical trials authorizations
- Ethical issues in biobanks
Speakers
Prof Samia Hurst, Dr Emilie Alirol, Dr Brigitte Happ
Date(s)
3 November 2025
4 November 2025
5 November 2025
Fee
1800 CHF
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
Speakers
Dr Catherine Deloche, Prof. Youssef Daali
Date(s)
24 November 2025
25 November 2025
Fee
1400 CHF
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)
Speakers
Dr François Curtin, Dr Fabiana Tirone
Date(s)
15 December 2025
16 December 2025
17 December 2025
18 December 2025
Fee
2200 CHF
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
Speakers
Dr François Curtin, Dr David W Warne
Date(s)
19 January 2026
20 January 2026
21 January 2026
Fee
1800 CHF
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
Speakers
Dr Shelly Bustion, Dr Sandrine Charvat
Date(s)
9 February 2026
10 February 2026
11 February 2026
Fee
1800 CHF
Description
- 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
Speakers
TBC
Date(s)
9 March 2026
10 March 2026
11 March 2026
Fee
1800 CHF
Planning
Dates to be confirmed
Description
- Quality management systems
- Audit
- Purpose and Conduct of regulatory inspections
- Site preparation to inspections
Speakers
Dr Isabelle Mercier, Dr Isabelle Semac
Date(s)
24 March 2026
Fee
1000 CHF
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?
Speakers
Dr Lucie Bouchoud, Prof Farshid Sadeghipour, Dr Laurent Carrez
Date(s)
24 March 2026
Fee
1000 CHF
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
Speakers
Prof Carole Bourquin, Dr Valérie Dutoit-Vallotton
Date(s)
20 April 2026
21 April 2026
22 April 2026
Fee
1800 CHF
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
Speakers
Dr Brigitte Happ, Dr Enrica Alteri
Date(s)
11 May 2026
12 May 2026
Fee
1400 CHF
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
Speakers
Dr Mariagrazia Di Marco, Me Gabriel Avigdor
Date(s)
8 June 2026
9 June 2026
10 June 2026
Fee
1800 CHF
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
Speakers
Prof Youssef Daali, Dr Enrica Alteri
Pedagogical method
Lectures, interactive seminars, and workshops.
All teaching is conducted in English.
Partnerships / Collaboration
Accreditation / Recognition / Certification
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
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
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
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