DAS Management of Clinical Trials 2021

Good Clinical Practice implementation and quality processes provide a theoretical and practical understanding of how these principles are shaping each step of a Clinical Trial, including study design, trial management and conduct.

Information

Period

September 2021 - May 2022
33 ECTS credits
160 Teaching hours
Language: bilingual French/English

Language

English

Format

On-site – switch over to online-learning if required

Contact

+41 (0)22 372 91 56 / 079 553 76 40
das.clinicaltrials(at)hcuge.ch

Location

Geneva

Registration

Registration deadline

31 July 2021
Modules can be followed individually
For individual modules, application should be sent at least one month prior to the beginning of the selected module (2 to 12). Priority will be given to candidates applying for the Diploma.

Fees:

CHF 7’500.- for the Diploma
CHF 1’500.- for individual modules

Contribution to the SDGs

Goal 3: Ensure healthy lives and promote well-being for all at all ages Goal 17: Strengthen the means of implementation and revitalize the Global Partnership for Sustainable Development

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

Medical doctor, biologist, pharmacist, nurse, biochemist and other professional involved, or wishing to gain skills and knowledge in the field of clinical research

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. Jules DESMEULES and Dr François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva

Coordinator(s)

Dr François CURTIN, Dr Catherine DELOCHE, Dr Françoise LACOMBE, Faculty of Medicine, University of Geneva

Accreditation

The course is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals (SwAPP), Swiss Society of Clinical Pharmacology and Toxicology (SGKPT-SSPTC), Swiss Institute for postgraduate and continuous medical education (SWIF-ISFM)

Fee

1500 CHF

Speakers

Dr Angèle Gayet-Ageron - Dr François Curtin

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

Planning

September 13, 14, 15, 2021

Fee

1500 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
  • Clinical Trial Agreements (CTA) and authorship issues
  • Ethical issues in biobanks

Planning

October 11, 12, 13, 2021

Fee

1500 CHF

Speakers

Prof. Gerrit Borchard - Prof. Youssef Daali - Dr Catherine Deloche - Dr Marie Besson

Description

  • Pharmacodynamics
  • Pharmacokinetics
  • Toxicology
  • Drug metabolism
  • Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)

Planning

November 23, 2021

Fee

1500 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)

Planning

December 13, 14, 2021

Fee

1500 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
  • Submission to Swiss Ethics Committee (EC) and Swiss Regulatory Authorities (RA)

Planning

January 17, 18, 19, 2022

Fee

1500 CHF

Speakers

Ms Jennifer Kealy - Ms Virginie Vida

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

Planning

February 21, 22, 23, 2022

Fee

1500 CHF

Speakers

Dr Mariagrazia Di Marco, Dr Françoise Lascombes

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

Planning

March 14, 2022

Fee

1500 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
  • Conformity assessment and CE marking
  • Materiovigilance
  • Digital health and medical software
  • Combination products

Planning

March 15, 16, 2022

Fee

1500 CHF

Speakers

Dr Isabelle Mercier, Dr Isabelle Semac

Description

  • Quality management systems
  • Audit
  • Purpose and conduct of regulatory inspections
  • Site preparation to inspections

Planning

May 16, 17, 18, 2022

Assessment

Dissertation : students may choose between vocational training in a pharmaceutical company, a Clinical Research Organization (CRO) or a Clinical Trial Unit in a University Hospital (320 hours over 3-4 months) or the development of a Clinical Trial protocol or a literature review and dissertation (320 hours).

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)

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

Goal 3: Ensure healthy lives and promote well-being for all at all ages Goal 17: Strengthen the means of implementation and revitalize the Global Partnership for Sustainable Development

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