MAS Drug Discovery and Clinical Development 2022
This MAS is aimed at professionals from academia, the pharmaceutical industry, biotechnology sector, and international organisations who wish to gain an in-depth understanding of drugs and medical devices research and development.
Information
Period
August 2022 - June 202360 ECTS credits
280 Teaching hours
Every 2 years
Language
EnglishFormat
On-site – switch over to online-learning if requiredRegistration
Registration deadline
13 August 2022Modules can be followed individually
Fees:
CHF 15’500.- for the Master
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 Dr François CURTIN, Faculty of Medecine, University of Geneva
Coordinator(s)
Dr François CURTIN, University of Geneva, Dr Catherine DELOCHE, Solid Drug Development and 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
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Date(s)
29 August 2022
30 August 2022
31 August 2022
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
Date(s)
26 September 2022
27 September 2022
28 September 2022
Fee
1800 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
Date(s)
17 October 2022
18 October 2022
19 October 2022
Fee
1800 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
Date(s)
14 November 2022
15 November 2022
10 May 2022
Fee
1800 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
Date(s)
28 November 2022
29 November 2022
Fee
1400 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)
Date(s)
19 December 2022
20 December 2022
21 December 2022
22 December 2022
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
Date(s)
16 January 2023
17 January 2023
18 January 2023
Fee
1800 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)
Date(s)
13 February 2023
14 February 2023
15 February 2023
Fee
1800 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
Date(s)
13 March 2023
14 March 2023
15 March 2023
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
Date(s)
20 March 2023
Fee
1000 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
Date(s)
21 March 2023
22 March 2023
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
Date(s)
9 May 2023
10 May 2023
11 May 2023
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
Date(s)
5 June 2023
6 June 2023
7 June 2023
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 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