DAS Management of Clinical Trials 2022
Information
Period
September 2022 - May 2023Language
EnglishFormat
On-site – switch over to online-learning if requiredRegistration
Registration deadline
13 August 2022Fees:
CHF 9’000.- for the Diploma
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 knowledge and understanding of drug development and marketing authorization processes
- Enable participants to understand issues related to human subject research
- Describe the different clinical trial designs and methodologies
- Give a theoretical and practical insight on project planning and management in clinical trials
- Provide effective tools to comply with clinical research regulations and Good Clinical Practices (GCP)
- Enable participants to successfully manage trial applications to ethics committees and regulatory authorities
- Illustrate how to implement quality systems in clinical trials
Audience
Learning outcomes
- Understand and use in a relevant context the different Clinical Trial designs and methodologies
- Be familiar with drug development and marketing authorization processes
- Gain knowledge of GCP and of clinical research regulations in Switzerland, Europe and the United States
- Become skilled at developing Case Report Form (CRF)
- Coordinate the development of clinical trial protocols
- Master effective project planning and management
- Know how to manage applications for Ethics Committee (EC) and Regulatory Authority (RA)
- Understand and implement Quality Systems used in Clinical Trials
- Understand the issues related to research subject protection
Programme
9 modules:
- Principles and Methods in Clinical Research
- Ethical and Legal Aspects
- Preclinical Pharmacology, Toxicology and Clinical Pharmacology
- Safety Management in Drug Development
- Clinical Trials Set-up and Conduct – Part 1
- Clinical Trials Set-up and Conduct – Part 2
- Clinical Trials Close-out and Reporting
- Medical Devices
- Audits and Inspections
Thesis
Director(s)
Prof. Youssef DAALI and Dr François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva
Coordinator(s)
Accreditation
Date(s)
Fee
Speakers
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)
Fee
Speakers
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
- Clinical Trial Agreements (CTA) and authorship issues
- Ethical issues in biobanks
Date(s)
Fee
Speakers
Description
- Pharmacodynamics
- Pharmacokinetics
- Toxicology
- Drug metabolism
- Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)
Date(s)
Fee
Speakers
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)
Fee
Speakers
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
- Submission to Swiss Ethics Committee (EC) and Swiss Regulatory Authorities (RA)
Date(s)
Fee
Speakers
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)
Fee
Speakers
Description
- Clinical trial close-out activities
- Data cleaning and database lock
- Statistical Analysis Plan and result reporting (SAP)
- Medical writing and clinical study report
- Safety reconciliation and MedDRA coding
Date(s)
Fee
Speakers
Description
- Medical devices (MD) and new EU regulations (MDR, IVDR)
- Qualification and classification
- Clinical investigation and clinical trial application to authorities
- Market access strategy
- Conformity assessment and CE marking
- Materiovigilance
- Digital health and medical software
- Combination products
Date(s)
Fee
Speakers
Description
- Quality management systems
- Audit
- Purpose and conduct of regulatory inspections
- Site preparation to inspections
Assessment
A vocational training in a pharmaceutical company, a Clinical Research Organization (CRO) or a Clinical Trial Unit in a University Hospital (3-4 months) followed by a report.
The development of a Clinical Trial protocol or a literature review and dissertation.
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 Sciences plus a minimum of 1 year professional experience in the field of the DAS
- Good understanding of both French (knowledge equivalent to B2 Level) and English (knowledge equivalent to the Cambridge First Certificate)
- The candidates who follow the programme during their working time must provide written authorization from their employer.
Steering committee
Prof. Gerrit Borchard, Head of Biopharmaceutics, Section of Pharmaceutical Sciences, Faculty of Science, University of Geneva
Prof. Cem Gabay, Dean of the Faculty of Medicine, 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. Angèle Gayet-Ageron, Head of the Methodological Support Unit, Clinical Research Centre (CRC), University Hospitals of Geneva, Faculty of Medecine, University of Geneva
Prof. Arnaud Perrier, Medical Director, University Hospitals 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 Gabriele Ackermann, Chief Scientific Officer ad interim, Therapeutic Area Head Cardiovascular, Renal & Metabolism Therapeutic Area Head Respiratory, Novartis Pharma Switzerland
Dr Emilie Alirol, Medicines for Malaria Venture, Associate Director, Access and Product Management
Dr Enrica Alteri, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division, EMA
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 & Lecturer at Hospitals of Geneva (UNIGE)
Prof. Youssef Daali, Head of the laboratory of the Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva, 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. Philippe Ducor, Faculty of Law, University of Geneva
Prof. Marc Froissart, Medical Director of the Clinical Research Centre (CRC), CHUV-UNIL, Lausanne
Prof. Angèle Gayet-Ageron, 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, Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva and Faculty of Medicine, University of Geneva
Schedule
Monday, Tuesday, Wednesday
Remarks
Candidates are warned that a significant amount of self-study is required to complete the DAS, and that they are expected to go through preparatory work before each module. Students should thus allow sufficient time to study at home, in addition to attending the classroom lectures.
Contribution to the SDGs