Diploma of Advanced Studies Diplôme de formation continue. Management of Clinical Trials. Good Clinical Practice Implementation and Quality Processes

Transcription

1 DAS Diploma of Advaced Studies Diplôme de formatio cotiue Maagemet of Cliical Trials Good Cliical Practice Implemetatio ad Quality Processes September 2016 > September 2017 CRC Cetre de Recherche Cliique

2 Programme Director Prof. Jules Desmeules, Head of the Cliical Trial Uit, Cliical Research Ceter (CRC), Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva Coordiatio Dr Emilie Alirol, Cliical Trial Maager, Cliical Trial Uit, Cliical Research Ceter, Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva Ms Isabelle Lagrage, Admiistrative Assistat of the DAS, Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva Ms Corie Chaudet, Assistat of the Cliical Trial Uit, Cliical Research Ceter, Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva 2 drugdevelopmet.uige.ch

3 A essetial step for trasitioig your career to cliical research I the past two decades, the umber of Cliical Trials coducted i Switzerlad ad worldwide has virtually exploded. This tremedous icrease wet had i had with the developmet of codes, guidelies ad regulatios aimed at protectig huma research subjects. Stadardizatio ad stregtheig of cliical research regulatios have led to the developmet of a rapidly growig ecoomic sector i which Cliical Research Associates (CRA), Cliical Research Scietists (CRS), Data Maagers (DM), Cliical Research Coordiators (CRC), Cliical Trial Maagers (CTM) ad regulatory affairs specialists are key players. The Diploma of Advaced Studies (DAS) i Maagemet of Cliical Trials Good Cliical Practice Implemetatio ad Quality Processes provides a theoretical ad practical uderstadig of how Good Cliical Practice (GCP) priciples are shapig each step of a Cliical Trial, icludig study desig, trial maagemet ad coduct. drugdevelopmet.uige.ch 3

4 Steerig Committee Prof. Heri Bouameaux, Dea of the Faculty of Medicie, Uiversity of Geeva Prof. Araud Perrier, Medical Director, Uiversity Hospitals of Geeva Prof. Gerrit Borchard, Vice-Presidet, Sectio of Pharmaceutical Scieces, Faculty of Sciece, Uiversity of Geeva Prof. Berard Hirschel, Presidet, Catoal Commissio o Huma Research Ethics, Cato of Geeva Prof. Samia Hurst, Director, Istitute of Ethics, History ad Humaities (ieh2), Faculty of Medicie, Uiversity of Geeva Prof. Thomas Pereger, Head of the Methodological Uit, Cliical Research Ceter (CRC), Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva Prof. Jérôme Pugi, Vice-Dea of the Faculty of Medicie ad Presidet of the Cliical Research Ceter (CRC), Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva 4 drugdevelopmet.uige.ch

5 Scietific Committee Dr Emilie Alirol, Cliical Trial Maager, Cliical Research Cetre (CRC), Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva Dr Maica Balasegaram, Director, Dyamic Portfolio, GARD Partership Operatios, DNDi Dr Vaya Beltrami, Vice-Presidet, Head of Maufacturig, Aergis, Lausae Dr Jocelye Chabert, Cliical Research Associate, Cliical Research Cetre (CRC), Uiversity Hospitals of Geeva, Faculty of Medicie, Uiversity of Geeva Dr Fracois Curti, Chief Operatig Officer, Geeuro, Geeva Dr Patricia Delaite, Medical Director, Icyte, Geeva Dr Catherie Deloche, Chief Operatig Officer, SOLID, Geeva Prof. Philippe Ducor, Faculty of Law, Uiversity of Geeva Prof. Michel Lièvre, Cliical Pharmacology Departmet, Faculty of Medicie Laeec, Lyo Uiversity Hospitals, Frace Dr Christie Maure, Techical Officer, Immuizatio, Vaccies ad Biologicals, World Health Orgaizatio (WHO), Geeva Dr Corie Merle, Scietist, Itervetio ad Implemetatio research uit, Special Programme for research ad traiig i tropical diseases (TDR), World Health Orgaizatio (WHO), Geeva Dr Roch Ogier, Chief Scietific Officer, Novartis Pharma, Rotkreuz Prof. Hervé Porchet, Chief Medical Officer, Geeuro, Geeva drugdevelopmet.uige.ch 5

6 Topics Methodology of cliical trials, data maagemet ad aalysis Ethical priciples of cliical research, regulatios applicable to cliical research i Switzerlad, Europe ad Uited States Project maagemet ad coordiatio i cliical research Quality systems i cliical research Safety aspects of drug developmet, pharmaco-vigilace ad pharmaco-epidemiology Drug developmet ad marketig authorizatio process Skills ad Competecies Uderstad ad use i a relevat cotext the differet Cliical Trial desigs ad methodologies Be familiar with drug developmet ad marketig authorizatio processes Gai kowledge of GCP ad of cliical research regulatios i Switzerlad, Europe ad the Uited States Become skilled at developig Case Report Form (CRF) Coordiate the developmet of cliical trial protocols Master effective project plaig ad maagemet Kow how to maage applicatios for Ethics Committee (EC) ad Regulatory Authority (RA) Uderstad ad implemet Quality Systems used i Cliical Trials Uderstad the issues related to research subject protectio 6 drugdevelopmet.uige.ch

7 Target Audiece Medical doctors, biologists, pharmacists, urses, biochemists ad other professioals ivolved, or wishig to gai skills ad kowledge, i the field of cliical research Learig Methods Lectures, iteractive semiars, workshops, vocatioal traiig. Teachig is i Eglish or i Frech Dissertatio Studets may choose betwee: A vocatioal traiig i a pharmaceutical compay, a Cliical Research Orgaizatio (CRO) or a Cliical Trial Uit i a Uiversity Hospital (320 hours over 3-4 moths) The developmet of a Cliical Trial protocol or a literature review ad dissertatio (320 hours) Diploma Awarded Participats who successfully complete the programme will be awarded the Diploma of Advaced Studies i Maagemet of Cliical Trials Good Cliical Practice Implemetatio ad Quality Processes / Diplôme de formatio cotiue e Gestio des Essais Cliiques Mise e applicatio des boes pratiques et processus qualité delivered by the Uiversity of Geeva. It equates to 33 ECTS (Europea Credit Trasfer ad Accumulatio System) credits drugdevelopmet.uige.ch 7

8 P r o g r a m m e Programme Structure 8 modules over oe year (average 24 hours of teachig per module) Teachig: 160 hours Dissertatio: 320 hours Number of ECTS credits: 33 Each module is subjected to a evaluatio i order to be accredited Modules 1 to 7 may be atteded idividually M odule 2A Precliical Pharmacology, Toxicology ad Cliical Pharmacology September 14, 2016 Prof. Gerrit Borchard, Dr Youssef Daali, Dr Catherie Deloche, Dr Marie Besso Basics of pharmacology Safety assessmet i pre-cliical research Ivestigatioal Medicial Product Dossier (IMPD) ad Ivestigator Brochure (IB) M odule 3 Safety Maagemet ad Drug Developmet September 19, 20, 2016 Prof. Jules Desmeules, Dr Victoria Rollaso, Prof. Michel Lièvre Risk maagemet ad safety moitorig durig drug developmet Safety assessmet, documetatio ad reportig durig cliical trials Pre- ad post-marketig pharmacovigilace Role of Data ad Safety Moitorig Boards (DSMB) 8 drugdevelopmet.uige.ch

9 M odule 4 Priciples ad Methods of Cliical Research October 3, 4, 5, 2016 Prof. Thomas Pereger, Dr Agèle Gayet-Agero Developmet of research questios ad choice of edpoits Study desigs Statistical methods used i cliical research Priciples of Radomized Cotrolled Trials (RCT) Critical review of publicatios Developmet of study protocols Choice of edpoits Sample size calculatio Iterim aalysis plaig M odule 6 Ethical ad Legal Aspects December 5, 6, 7, 2016 Prof. Samia Hurst, Prof. Philippe Ducor, Dr Brigitte Happ Cliical research ethics Iformed coset process Data protectio ad cofidetiality Purpose ad fuctio of research Ethics Committees (EC) Assessig risks ad beefits to research participats Vulerable populatios Good cliical practices Legal framework applicable i Switzerlad, Europe ad the Uited States for drugs, medical device ad o-itervetioal trials Cliical Trial Agreemets (CTA) ad authorship issues Ethical issues i biobaks drugdevelopmet.uige.ch 9

10 M odule 7 Plaig of Cliical Trials Jauary 11, 12, 13, 2017 Dr Roch Ogier, Dr Maica Balasegaram Scietific, strategic ad safety cosideratios i cliical trial desig Budget developmet ad resource plaig Ivestigator sites selectio Role of CROs ad exteral providers Cliical trial documets Case Report Forms (CRFs) developmet Stadard Operatio Procedures (SOP) Submissio to Ethics Committee (EC) ad otificatio to Regulatory Authorities (RA) M odule 8 Coduct ad Maagemet of Cliical Trials February 6, 7, 8, 2017 Mrs Virgiie Vidal,Ms Jeifer Kealy Project maagemet applied to cliical trials Recruitmet ad retetio of study subjects Maagemet of radomizatio ad blidig systems Data collectio ad data maagemet Maagemet of ivestigatioal medicial product Documets ad records Moitorig of cliical studies Root-cause aalysis 10 drugdevelopmet.uige.ch

11 Module 10 Close-out ad Reportig of Cliical Trials April 5, 6, 2017 Dr Roch Ogier, Dr Mariagrazia Di Marco Study close-out activities Data cleaig ad database lock Preparatio of Statistical Aalysis Pla (SAP) Results review ad iterpretatio Dissemiatio ad publicatios of study results Cliical trials reportig Dossier preparatio ad submissio for Marketig Authorizatio Applicatios (MAA) Regulatory specificities of medical devices, orpha drugs ad pediatric drugs M odule 11 Audits ad Ispectios May 22, 23, 24, 2017 Dr Emilie Alirol, Dr Jocelye Chabert Quality maagemet systems Purpose ad coduct of regulatory ispectios Audit Site preparatio to ispectios. drugdevelopmet.uige.ch 11

12 Geeral Iformatio Admissio Criteria Title of physicia Or master s or bachelor s degree i Life Sciece or title deemed equivalet Or Bachelor s degree from a Swiss Uiversity of Applied Scieces plus a miimum of 1 year professioal experiece i the field of the DAS Good uderstadig of both Frech (kowledge equivalet to B2 Level) ad Eglish (kowledge equivalet to the Cambridge First Certificate) The cadidates who follow the programme durig their workig time must provide writte authorizatio from their employer. Applicatio ad Deadlie Olie applicatio may be submitted via the course website at: drugdevelopmet.uige.ch Cadidates should sed copies of relevat uiversity degrees, a curriculum Vitae, a coverig letter, two referece letters ad a writte authorizatio from their employer by Jue 15, 2016 to the DAS secretariat (DAS.cliicaltrials@hcuge.ch). Cadidates should metio i their cover letter if they wat to realize a vocatioal traiig as DAS thesis. For idividual modules, applicatio should be set at least oe moth prior to the begiig of the selected module (1 to 7). Priority will be give to cadidates applyig for the Diploma. The DAS is etirely paperless ad studets are ecouraged to brig their laptop durig classes. 12 drugdevelopmet.uige.ch

13 Importat ote Cadidates are wared that a sigificat amout of self-study is required to complete the DAS, ad that they are expected to go through preparatory work before each module. Studets should thus allow sufficiet time to study at home, i additio to attedig the classroom lectures. Tuitio Fee CHF 7,500.- for the Diploma CHF 1,500.- for idividual module Accreditatio The course program is accredited by: Swissethics Swiss Associatio of Pharmaceutical Professioals (SwAPP) Swiss Society of Cliical Pharmacology ad Toxicology Course Locatio Campus Biotech 9 chemi des Mies-1202 Geève Bus 1 ad 25 directio Jardi Botaique stop Mies Bus 11 directio Jardi Botaique stop Jardi Botaique Fodatio Louis Jeatet 77 route de Florissat-1208 Geève Bus 2 ad 8 directio Veyrier, stop Louis-Aubert Cotact DAS.cliicaltrials@hcuge.ch drugdevelopmet.uige.ch drugdevelopmet.uige.ch 13

14 Uiversity Cetre for Cotiuig ad Distace Educatio