das diploma of advanced studies · prior to the beginning of the selected module (1 to 7). priority...

Management of Clinical TrialsGood Clinical Practice Implementation

and Quality Processes September 2016 > September 2017

CRC Centre deRechercheClinique

DAS Diploma of Advanced StudiesDiplôme de formation continue

2 drugdevelopment.unige.ch

Programme DirectorProf. Jules Desmeules, Head of the Clinical Trial Unit, Clinical ResearchCenter (CRC), University Hospitals of Geneva, Faculty of Medicine,University of Geneva

Coordination n Dr Emilie Alirol, Clinical Trial Manager, Clinical Trial Unit, Clinical

Research Center, University Hospitals of Geneva, Faculty of Medicine,University of Geneva

n Ms Isabelle Lagrange, Administrative Assistant of the DAS, UniversityHospitals of Geneva, Faculty of Medicine, University of Geneva

n Ms Corinne Chaudet, Assistant of the Clinical Trial Unit, ClinicalResearch Center, University Hospitals of Geneva, Faculty of Medicine,University of Geneva

n the past two decades, the number of Clinical Trials conducted inSwitzerland and worldwide has virtually exploded. This tremendousincrease went hand in hand with the development of codes,guidelines and regulations aimed at protecting human research

subjects. Standardization and strengthening of clinical researchregulations have led to the development of a rapidly growing economicsector in which Clinical Research Associates (CRA), Clinical ResearchScientists (CRS), Data Managers (DM), Clinical Research Coordinators(CRC), Clinical Trial Managers (CTM) and regulatory affairs specialists arekey players.

The Diploma of Advanced Studies (DAS) in Management of Clinical Trials –Good Clinical Practice Implementation and Quality Processes provides atheoretical and practical understanding of how Good Clinical Practice(GCP) principles are shaping each step of a Clinical Trial, including studydesign, trial management and conduct.

An essential step for transitioning your career to clinical research

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Steering Committeen Prof. Henri Bounameaux, Dean of the Faculty of Medicine, University

of Geneva

n Prof. Arnaud Perrier, Medical Director, University Hospitals of Geneva

n Prof. Gerrit Borchard, Vice-President, Section of PharmaceuticalSciences, Faculty of Science, University of Geneva

n Prof. Bernard Hirschel, President, Cantonal Commission on HumanResearch Ethics, Canton of Geneva

n Prof. Samia Hurst, Director, Institute of Ethics, History andHumanities (iEH2), Faculty of Medicine, University of Geneva

n Prof. Thomas Perneger, Head of the Methodological Unit, ClinicalResearch Center (CRC), University Hospitals of Geneva, Faculty ofMedicine, University of Geneva

n Prof. Jérôme Pugin, Vice-Dean of the Faculty of Medicine andPresident of the Clinical Research Center (CRC), University Hospitalsof Geneva, Faculty of Medicine, University of Geneva



Scientific Committeen Dr Emilie Alirol, Clinical Trial Manager, Clinical Research Centre (CRC),

University Hospitals of Geneva, Faculty of Medicine, University ofGeneva

n Dr Manica Balasegaram, Director, Dynamic Portfolio, GARDPartnership Operations, DNDi

n Dr Vanya Beltrami, Vice-President, Head of Manufacturing, Anergis,Lausanne

n Dr Jocelyne Chabert, Clinical Research Associate, Clinical ResearchCentre (CRC), University Hospitals of Geneva, Faculty of Medicine,University of Geneva

n Dr Francois Curtin, Chief Operating Officer, Geneuro, Geneva

n Dr Patricia Delaite,Medical Director, Incyte, Geneva

n Dr Catherine Deloche, Chief Operating Officer, SOLID, Geneva

n Prof. Philippe Ducor, Faculty of Law, University of Geneva

n Prof. Michel Lièvre, Clinical Pharmacology Department, Faculty ofMedicine Laennec, Lyon University Hospitals, France

n Dr Christine Maure, Technical Officer, Immunization, Vaccines andBiologicals, World Health Organization (WHO), Geneva

n Dr Corinne Merle, Scientist, Intervention and Implementationresearch unit, Special Programme for research and training intropical diseases (TDR), World Health Organization (WHO), Geneva

n Dr Roch Ogier, Chief Scientific Officer, Novartis Pharma, Rotkreuz

n Prof. Hervé Porchet, Chief Medical Officer, Geneuro, Geneva


Topicsn Methodology of clinical trials, data management and analysis

n Ethical principles of clinical research, regulations applicable toclinical research in Switzerland, Europe and United States

n Project management and coordination in clinical research

n Quality systems in clinical research

n Safety aspects of drug development, pharmaco-vigilance andpharmaco-epidemiology

n Drug development and marketing authorization process

Skills and Competenciesn Understand and use in a relevant context the different Clinical Trial

designs and methodologies

n Be familiar with drug development and marketing authorizationprocesses

n Gain knowledge of GCP and of clinical research regulations inSwitzerland, Europe and the United States

n Become skilled at developing Case Report Form (CRF)

n Coordinate the development of clinical trial protocols

n Master effective project planning and management

n Know how to manage applications for Ethics Committee (EC) andRegulatory Authority (RA)

n Understand and implement Quality Systems used in Clinical Trials

n Understand the issues related to research subject protection


Target AudienceMedical doctors, biologists, pharmacists, nurses, biochemists and otherprofessionals involved, or wishing to gain skills and knowledge, in thefield of clinical research

Learning MethodsLectures, interactive seminars, workshops, vocational training. Teachingis in English or in French

DissertationStudents may choose between:n A vocational training in a pharmaceutical company, a Clinical Research

Organization (CRO) or a Clinical Trial Unit in a University Hospital (320hours over 3-4 months)

n The development of a Clinical Trial protocol or a literature reviewand dissertation (320 hours)

Diploma AwardedParticipants who successfully complete the programme will be awardedthe Diploma of Advanced Studies in Management of Clinical Trials – GoodClinical Practice Implementation and Quality Processes / Diplôme deformation continue en Gestion des Essais Cliniques – Mise en applicationdes bonnes pratiques et processus qualité delivered by the University ofGeneva. It equates to 33 ECTS (European Credit Transfer and AccumulationSystem) credits

Programme Structuren 8 modules over one year (average 24 hours of teaching per module) n Teaching: 160 hoursn Dissertation: 320 hoursn Number of ECTS credits: 33 n Each module is subjected to an evaluation in order to be accreditedn Modules 1 to 7 may be attended individually

Module 2A | Preclinical Pharmacology, Toxicology and ClinicalPharmacology

September 14, 2016

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

n Basics of pharmacology

n Safety assessment in pre-clinical research

n Investigational Medicinal Product Dossier (IMPD)and Investigator Brochure (IB)

Module 3 | Safety Management and Drug Development

September 19, 20, 2016

Prof. Jules Desmeules, Dr Victoria Rollason,Prof. Michel Lièvre

n Risk management and safety monitoring during drugdevelopment

n Safety assessment, documentation and reportingduring clinical trials

n Pre- and post-marketing pharmacovigilance

n Role of Data and Safety Monitoring Boards (DSMB)


P r o g r a m m e

Module 4 | Principles and Methods of Clinical ResearchOctober 3, 4, 5, 2016

Prof. Thomas Perneger, Dr Angèle Gayet-Ageronn Development of research questions and choice of

endpointsn Study designsn Statistical methods used in clinical researchn Principles of Randomized Controlled Trials (RCT)n Critical review of publicationsn Development of study protocolsn Choice of endpointsn Sample size calculationn Interim analysis planning

Module 6 | Ethical and Legal AspectsDecember 5, 6, 7, 2016

Prof. Samia Hurst, Prof. Philippe Ducor, Dr Brigitte Happn Clinical research ethicsn Informed consent processn Data protection and confidentialityn Purpose and function of research Ethics Committees (EC)n Assessing risks and benefits to research participantsn Vulnerable populationsn Good clinical practicesn Legal framework applicable in Switzerland, Europe

and the United States for drugs, medical device andnon-interventional trials

n Clinical Trial Agreements (CTA) and authorship issuesn Ethical issues in biobanks


Module 7 | Planning of Clinical Trials

January 11, 12, 13, 2017

Dr Roch Ogier, Dr Manica Balasegaram

n Scientific, strategic and safety considerations inclinical trial design

n Budget development and resource planningn Investigator sites selection n Role of CROs and external providersn Clinical trial documentsn Case Report Forms (CRFs) developmentn Standard Operation Procedures (SOP)n Submission to Ethics Committee (EC) and notification

to Regulatory Authorities (RA)

Module 8 | Conduct and Management of Clinical Trials

February 6, 7, 8, 2017

Mrs Virginie Vidal ,Ms Jennifer Kealy

n Project management applied to clinical trialsn Recruitment and retention of study subjects n Management of randomization and blinding systemsn Data collection and data managementn Management of investigational medicinal product n Documents and recordsn Monitoring of clinical studiesn Root-cause analysis


Module 10 | Close-out and Reporting of Clinical Trials

April 5, 6, 2017

Dr Roch Ogier, Dr Mariagrazia Di Marco

n Study close-out activities

n Data cleaning and database lock

n Preparation of Statistical Analysis Plan (SAP)

n Results review and interpretation

n Dissemination and publications of study results

n Clinical trials reporting

n Dossier preparation and submission for MarketingAuthorization Applications (MAA)

n Regulatory specificities of medical devices, orphandrugs and pediatric drugs

Module 11 | Audits and Inspections

May 22, 23, 24, 2017

Dr Emilie Alirol, Dr Jocelyne Chabert

n Quality management systemsn Purpose and conduct of regulatory inspectionsn Auditn Site preparation to inspections

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General InformationAdmission Criterian Title of physiciann Or master’s or bachelor’s degree in Life Science or title deemed

equivalentn Or Bachelor’s degree from a Swiss University of Applied Sciences plus

a minimum of 1 year professional experience in the field of the DASn Good understanding of both French (knowledge equivalent to B2

Level) and English (knowledge equivalent to the Cambridge FirstCertificate)

The candidates who follow the programme during their working timemust provide written authorization from their employer.

Application and DeadlineOnline application may be submitted via the course website at: drugdevelopment.unige.chn Candidates should send copies of relevant university degrees, a

curriculum Vitae, a covering letter, two reference letters and a writtenauthorization from their employer by June 15, 2016 to the DASsecretariat ([email protected]). Candidates should mentionin their cover letter if they want to realize a vocational training as DASthesis.

n For individual modules, application should be sent at least one monthprior to the beginning of the selected module (1 to 7). Priority will begiven to candidates applying for the Diploma.

n The DAS is entirely paperless and students are encouraged to bringtheir laptop during classes.


Important noteCandidates are warned that a significant amount of self-study is requiredto complete the DAS, and that they are expected to go throughpreparatory work before each module. Students should thus allowsufficient time to study at home, in addition to attending the classroomlectures.

Tuition Fee

n CHF 7,500.- for the Diploma

n CHF 1,500.- for individual module

AccreditationThe course program is accredited by:

n Swissethics

n Swiss Association of Pharmaceutical Professionals (SwAPP)

n Swiss Society of Clinical Pharmacology and Toxicology

Course Location

n Campus Biotech 9 chemin des Mines-1202 GenèveBus 1 and 25 – direction Jardin Botanique stop MinesBus 11 – direction Jardin Botanique stop Jardin Botanique

n Fondation Louis Jeantet77 route de Florissant-1208 GenèveBus 2 and 8 – direction Veyrier, stop Louis-Aubert

[email protected]

drugdevelopment.unige.ch

University Centre for Continuing and Distance Educationwww.unige.ch/formcont