How to improve Clinical Trials in Rare Diseases? Cécile COLOMBAN OrphanDev, CIC CPCET Timone, Marseille
|
|
- Noel Green
- 8 years ago
- Views:
Transcription
1 How to improve Clinical Trials in Rare Diseases? Cécile COLOMBAN OrphanDev, CIC CPCET Timone, Marseille Franco-British symposium on clinical research, 17th October 2012
2 National context Specificities of Rare Diseases Clinical Trials OrphanDev s structuration Our experience in Rare Diseases Clinical Trials
3 National context Specificities of Rare Diseases Clinical Trials OrphanDev s structuration Our experience in Rare Diseases Clinical Trials
4 FRANCE: A LEADING COUNTRY IN EU FOR RARE DISEASES HEALTH POLICIES AND INITIATIVES Strong lobbying of patients organizations AFM (French organization for Muscular Dystrophies) and Téléthon (TV program which collects funds dedicated to research on Rare Diseases) Rare diseases Alliance (more than 200 organizations) European database on Rare Diseases : ORPHANET (INSERM) website which provides information on Rare Diseases (RD) dedicated to clinicians, researchers, patients and general population
5 FRANCE: A LEADING COUNTRY IN EU FOR RARE DISEASES HEALTH POLICIES AND INITIATIVES National Plans for Rare Diseases To improve quality of care to patients suffering from RD : creation of Reference Centers (131) and Competence Centers (501) for RD : develop research thanks to a National Foundation
6 FRANCE: A LEADING COUNTRY IN EU FOR RARE DISEASES HEALTH POLICIES AND INITIATIVES An area of excellence in France (LEEM survey 2010 and 2012 about the place of France in international clinical research) Mean number of patients recruted by active center (Preliminary results, Soizic Courcier, oct 2012) Oncology/Onco-hematology Cardiovascular/Metabolism Diabetes Neurology/Psychiatry/Alzheimer 4,9 Scandinavie 11,4 Am. Latine 4,7 Europe Est 10,7 Australasie 4,1 Am. Latine 10,3 Asie 3,8 Asie 9,7 Europe Est 3,8 Australasie 9,5 Allemagne 3,5 Autres Eur. Ouest 9,0 Canada 3,4 Afr. Moyen Or. 8,8 Espagne 3,4 Royaume Uni 8,7 Scandinavie 3,4 Espagne 7,5 Autres Eur. Ouest 3,3 Allemagne 7,4 Etats-Unis 3,2 Etats-Unis 7,0 Royaume Uni 3,2 Canada 7,0 Afr. Moyen Or. Etats-Unis 3,2 Italie 6,1 Italie 2,8 France 4,6 France 4,0 Asie Europe Est Am. Latine Australasie France Scandinavie Canada Autres Eur. Ouest Allemagne Royaume Uni Afr. Moyen Or. Espagne Italie 7,9 7,8 7,7 7,6 6,9 6,9 5,8 5,6 5,5 5,3 4,9 4,2 12,0 Europe Est Afr. Moyen Or. Allemagne Canada Autres Eur. Ouest Espagne Asie Etats-Unis Australasie Am. Latine France Scandinavie Italie Royaume Uni 6,2 5,3 5,2 5,1 5,1 5,1 4,8 4,7 4,6 4,4 4,3 4,2 4,1 4,1 Anti Infectious/Virology/Vaccines Rares Diseases Inflammation/Rheumatology Respiratory diseases Asie Am. Latine Scandinavie Allemagne Europe Est Espagne France Australasie Royaume Uni Canada Etats-Unis Afr. Moyen Or. Autres Eur. Ouest 45,5 Asie 17,8 Autres Eur. Ouest 15,0 Royaume Uni 10,4 France 8,5 Am. Latine 8,2 Canada 7,9 Europe Est 7,7 Afr. Moyen Or. 6,8 Allemagne 6,6 Italie 6,3 Australasie Scandinavie 5,9 Etats-Unis 4,7 Italie Espagne 4,1 2,2 4,4 4,2 4,2 4,2 4,0 4,0 3,4 3,1 2,7 2,6 2,3 2,2 6,2 Am. Latine Europe Est Asie Canada Etats- Unis Australasie Allemagne Espagne France Scandinavie Italie Autres Eur. Ouest Royaume Uni Afr. Moyen Or. 5,4 5,2 4,8 4,5 4,3 4,2 3,6 3,3 3,3 3,2 3,0 2,9 6,5 7,5 Scandinavie Asie Afr. Moyen Or. Europe Est Australasie Allemagne Espagne Royaume Uni Etats-Unis Autres Eur. Ouest Am. Latine France Canada Italie 7,9 7,7 6,3 6,3 6,2 6,2 6,1 5,4 5,3 5,1 4,6 10,7 10,3 10,2
7 National context Specificities of Rare Diseases Clinical Trials OrphanDev s structuration Our experience in Rare Diseases Clinical Trials
8 SPECIFICITIES OF CLINICAL TRIALS IN RARE DISEASES Usual quality and regulatory requirements for all clinical trials (CT) Difficulties specific to rare diseases are added: Translational research
9 RARE DISEASES CLINICAL TRIALS: A NECESSARY ORGANISATIONAL MODEL The need: To overcome these organizational and methodological difficulties to: optimize the design and management of RD CT speed up the access to innovative therapeutics The answer: A network dedicated to the clinical DEVelopment of ORPHAN therapeutics : OrphanDev Aim to increase the number and the quality of RD CT
10 National context Specificities of Rare Diseases Clinical Trials OrphanDev s structuration Our experience in Rare Diseases Clinical Trials
11 RARE DISEASES CLINICAL TRIALS: A NECESSARY ORGANISATIONAL MODEL 2009: creation of OrphanDev In the Clinical Pharmacology Unit of the Timone Hospital, Marseille (CIC-CPCET), in a team with more than 25 years experience in CT Coordinated by Dr Joëlle MICALLEF Regional network Supported by CeNGEPS (National center of health products trials management)
12 RARE DISEASES CLINICAL TRIALS: A NECESSARY ORGANISATIONAL MODEL OrphanDev since 2011: National network Renewal of the CeNGEPS support Member of the French National Foundation for RD, directed by Pr Nicolas LEVY
13 RARE DISEASES CLINICAL TRIALS: A NECESSARY ORGANISATIONAL MODEL Involved in ECRIN-IA European Clinical Research Infrastructure Network Integrating Activity Coordinated by Jacques DEMOTES To structure pan-european investigating networks, focused on rare diseases, medical devices and nutrition. Involved in F-CRIN French part of ECRIN Directed by Vincent DIEBOLT, coordinated by Olivier RASCOL To reinforce the French Clinical Research in Europe and worldwide
14 ORPHANDEV: DEDICATED SKILLS FOR RARE DISEASES CLINICAL TRIALS REALISATION OrphanDev s customized solutions Adapted to each stakeholder s need (researcher, clinician, phamaceutical company, start-up ) Adapted to the specificity of each rare disease Few examples: Support in the translational process Scientific support in the study design Identification and choice of investigation centers Help in research of funding (call for projects ) Access to an expert platform in therapeutic evaluation Optimization and acceleration of the patients recruitment And many other solutions
15 National context Specificities of Rare Diseases Clinical Trials OrphanDev s structuration Our experience in Rare Diseases Clinical Trials
16 OUR EXPERIENCE IN RARE DISEASES: TRANSLATIONAL RESEARCH Clinical Trial in Charcot-Marie-Tooth 1A (CMT 1A) Clinical Trial in Rett Syndrome Clinical Trial in Progeria
17 OUR EXPERIENCE IN RARE DISEASES: FOCUS ON CMT 1A, A SUCCESS STORY 2005: First CT on CMT 1A phase II randomised placebo-controlled multicenter CT Dr Joëlle MICALLEF (PI), Clinical Pharmacology Unit, Marseille Collaboration of researchers, clinicians, pharmacologist, patients organizations A public-private partnership An orphan designation
18 OUR EXPERIENCE IN RARE DISEASES: FOCUS ON CMT 1A, A SUCCESS STORY The recruitment Multicenter study: 3 French centers Specific disposal to improve recruitment : a phone number in Marseille Involvement of the patients organizations 180 CMT 1A patients included in 28 months Highest number of patients recruited in a RD CT at this time
19 OUR EXPERIENCE IN RARE DISEASES: FOCUS ON CMT 1A, A SUCCESS STORY 2010: First industrial promoted CT on CMT 1A (ongoing) SAS Pharnext, EudraCT N phase II randomised placebo-controlled multicenter CT Pr Shahram ATTARIAN (PI), reference center for neuromuscular disorders, Marseille The recruitment Multicenter study: 6 French centers Involvement of the patients organizations before the CT A phone number in Marseille
20 OUR EXPERIENCE IN RARE DISEASES: FOCUS ON CMT 1A, A SUCCESS STORY The recruitment 80 CMT 1A patients included in 6 French centers in 8 months Respect of the inclusion period Role of a unique national phone number: Information for patients (single contact) time saving for investigators
21 OUR EXPERIENCE IN RARE DISEASES: A STRATEGY TO ACHIEVE THE RECRUITMENT The need for a strategy of recruitment set up before the trial adapted to each case Number of subjects required (choice of the good design alternative methodologies) Reference and competence centers Others care units (trajectory of patients in the healthcare system) Registries of patients Early involvement of patients organizations Centralized phone number
22 OUR EXPERIENCE IN RARE DISEASES: COMMUNICATION / TRAINING Training of investigators, students, patients organizations Workshops in congresses
23 CONCLUSION High standards required for CT Need for professional dedicated infrastructures All the more true for RD CT, due to: methodological and logistical difficulties existing public-private partnership model ORPHANDEV network dedicated to RD CT aims to meet the specific needs of support and synergy expressed by clinicians and researchers, whether academic or industrial acts in true partnership with existing structures
24 Thank you for your attention
ECRIN IA WP4 Breakout session: structuring a European rare disesase clinical research network ECRIN Annual meeting 15-17 may 2013 Warsaw
ECRIN IA WP4 Breakout session: structuring a European rare disesase clinical research network ECRIN Annual meeting 15-17 may 2013 Warsaw OrphanDev s experience in supporting Clinical Trials for rare diseases
More informationThe challenges of conducting clinical development in rare / orphan diseases: The Industry Perspective
The challenges of conducting clinical development in rare / orphan diseases: The Industry Perspective Thomas Meier, PhD (Chief Scientific Officer) Muscle Study Group, September 22, 2009 Agenda Santhera
More informationEURORDIS-NORD-CORD Joint Declaration of. 10 Key Principles for. Rare Disease Patient Registries
EURORDIS-NORD-CORD Joint Declaration of 10 Key Principles for Rare Disease Patient Registries 1. Patient Registries should be recognised as a global priority in the field of Rare Diseases. 2. Rare Disease
More informationEUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES
EUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES 24 OCTOBER 2011 INTRODUCTION 1. THE EUROPEAN CONTEXT Centres of expertise (CE) and European Reference
More informationFrance s attractiveness for international clinical trials in 2012: Sixth survey assessed by Leem (French Association of Pharmaceutical Companies)
France s attractiveness for international clinical trials in 2012: Sixth survey assessed by Leem (French Association of Pharmaceutical Companies) 2012 survey assessed by Leem (French Pharmaceutical Companies
More informationReport from the visiting commitee
Section des Unités de recherche Report from the visiting commitee Research unit: Biothérapies hépatiques University of Nantes January 2008 Section des Unités de recherche Report from the visiting committee
More informationSingapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY
Singapore Clinical Trials Register Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Clinical Trial Register Global Trend EMA: EU Clinical Trials
More informationow centres of expertise should interface with social services The French experience : state of the art and current challenges
ow centres of expertise should interface with social services The French experience : state of the art and current challenges Christel Nourissier EURORDIS EUROPLAN Advisor 2 strategic Plans for rare diseases
More informationOverview of the EHR4CR project Electronic Health Record systems for Clinical Research
Overview of the EHR4CR project Electronic Health Record systems for Clinical Research Dipak Kalra UCL on behalf of the EHR4CR Consortium ENCePP Plenary Meeting, 3rd May 2012, London The problem (as addressed
More informationECONOMIC FOOTPRINT OF CTs IN BELGIUM STRATEGIC PLAN TO PROMOTE CTs
ECONOMIC FOOTPRINT OF CTs IN BELGIUM STRATEGIC PLAN TO PROMOTE CTs Ingrid Maes Director Pharma, Healthcare and Life Sciences PwC on behalf of: PwC on behalf of: PwC on behalf of: PwC PwC on behalf of:
More informationECRIN General Presentation
ECRIN General Presentation Supporting Clinical Trials Across Borders Gonzalo Calvo 26-01-16 ECRIN Overview A non-profit organisation with the legal status of European Research Infrastructure Consortium
More information«I-Reivac» Un réseau d excellence pour la recherche clinique en vaccinologie
«I-Reivac» Un réseau d excellence pour la recherche clinique en vaccinologie I-Reivac Pr Odile Launay Inserm, Université Paris Descartes, AP-HP, Hôpital Cochin, Paris F-CRIN, une infrastructure pour l
More informationIPROVE Innovation Partnership for a Roadmapon VaccinesinEurope
IPROVE Innovation Partnership for a Roadmapon VaccinesinEurope IPROVE IN BRIEF What is IPROVE? Whydo we need IPROVE? IPROVE in actions (How?) Partnership (Who?) WHAT An EU project (FP7) financed by the
More informationwww.terrapinn.com/orphandrug The top 50 social media influencers in orphan drugs and rare disease
The top 50 social media influencers in orphan drugs and rare disease Social media and the rare disease community Earlier this year at the 2013 edition of World Orphan Drug Congress USA I was excited to
More informationThe REUSE project: EHR as single datasource for biomedical research
The REUSE project: EHR as single datasource for biomedical research Naji El Fadly 1,3, Noël Lucas 2, Pierre-Yves Lastic 4, François Macary 5, Philippe Verplancke 6, Christel Daniel 1,2 1 INSERM UMRS 872,
More informationECRIN (European Clinical Research Infrastructures Network)
ECRIN (European Clinical Research Infrastructures Network) Wolfgang Kuchinke University of Duesseldorf (HHU) and ECRIN EUDAT 1st User Forum 7 March 2012 8 March 2012, Barcelona 1 What is ECRIN? European
More informationPATIENT INVOLVEMENT IN CLINICAL RESEARCH
PATIENT INVOLVEMENT IN CLINICAL RESEARCH A guide for Sponsors and Investigators Produced by the PatientPartner project funded by the 7th Framework Programme of the European Commission Table of contents
More informationERA-Net COFUND Research Programmes on Rare Diseases (E-RARE)
Bologna 15 Dicembre 2014 ERA-Net COFUND Research Programmes on Rare Diseases (E-RARE) The Role of RER-ASSR Antonio Addis Research Governance Area Agenzia Sanitaria e Sociale Regionale How do Regions might
More information«How can patient organisations trigger a EU funded rare disease project»
The European Prader Willi syndrome research project «How can patient organisations trigger a EU funded rare disease project» At first : a daily challenging rare disease A rare disease : Prader- Willi syndrome
More informationGOVERNANCE AND THE EHR4CR INSTITUTE
GOVERNANCE AND THE EHR4CR INSTITUTE Dipak Kalra EuroRec, University College London Christian Ohmann, European Clinical Research Infrastructure Network (ECRIN) Electronic Health Records for Clinical Research
More informationJournée des Industriels du Réseau TRIGGERSEP B. François CHU Limoges
Journée des Industriels du Réseau TRIGGERSEP B. François CHU Limoges Mercredi 3 juin 2015 Institut Pasteur Paris Why a sepsis network is needed? Sepsis places a burden on the healthcare system: 300 per
More informationClinical trials: The EU perspective. Dr Karim Berkouk, Deputy Head of Unit DG for Research and Innovation Health Directorate European Commission
Clinical trials: The EU perspective Dr Karim Berkouk, Deputy Head of Unit DG for Research and Innovation Health Directorate European Commission Content 1.EU: The global picture 2.EU & Clinial trials: The
More informationHR Software and Services in France in Good Health
PRESS RELEASE HR Software and Services in France in Good Health Paris, October 2007 The software and services market in Human Resources continues to rise and confirms trends from previous years. The year
More informationEcole Nationale d. Ecole Nationale d Ing Ingénieurs nieurs de Metz de Metz
Ecole Nationale d Ecole Nationale d Ing Ingénieurs nieurs de Metz de Metz Metz, the city... Built 2000 years ago A Republic in the Middle Ages A European crossroads A city oriented towards new technologies
More informationPediatric Research Networks A Plan for a Collaboration in Europe. Daniela Gunz Head Clinical Trial Operations Switzerland June 9, 2011
Pediatric Research Networks A Plan for a Collaboration in Europe Daniela Gunz Head Clinical Trial Operations Switzerland June 9, 2011 Agenda Challenges in clinical research in children EU pediatric regulation
More information9360/15 FMA/AFG/cb 1 DG G 3 C
Council of the European Union Brussels, 29 May 2015 (OR. en) 9360/15 OUTCOME OF PROCEEDINGS From: To: Council Delegations RECH 183 TELECOM 134 COMPET 288 IND 92 No. prev. doc.: 8970/15 RECH 141 TELECOM
More informationORPHANET Patient Services
ORPHANET Patient Services Marc HANAUER Webmaster for Patient Organisations Orphanet Patient Services Needs Understand their disease and its implications Identify resources Prevent isolation Find hope in
More informationOrphan Drugs & Personalised Medicine: The Patient Perspective
Orphan Drugs & Personalised Medicine: The Patient Perspective Dr. Cees Smit, Inspire2Live/VSOP/EGAN DCTF, Ede, October 8, 2014 a Patient Advocacy Platform, bringing together patients, doctors, scientists
More informationHealthcare Coalition on Data Protection
Healthcare Coalition on Data Protection Recommendations and joint statement supporting citizens interests in the benefits of data driven healthcare in a secure environment Representing leading actors in
More informationPEDIATRIC MEDICINES: GLOBAL MARKETS
PEDIATRIC MEDICINES: GLOBAL MARKETS PHM170A October 2014 Dr. Cheryl Lee Barton Project Analyst ISBN: 1-56965-971-0 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free
More informationLessons learnt from initiatives in the Netherlands
Lessons learnt from initiatives in the Netherlands Dutch Steering Committee on Orphan Drugs Frits Lekkerkerker Chairman 1 The start Recommendations of the Advisory Council on Health Research (RGO) in 1998
More informationEMA Update Clinical Trials
EMA Update Clinical Trials Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency 16 October 2012 An agency of the European Union Disclaimer The views presented in this presentation/these
More informationEarly Phase Clinical Trials: Public Access to the EU Database Repository
European CRO Federation Via Lucrezio Caro, 63 00193 Roma, Italy Tel.: +39 06 807 60 72 Fax: +39 06 807 60 85 Email: info@eucrof.eu Internet: www.eucrof.eu Early Phase Clinical Trials: Public Access to
More informationClinicians and patients needs and expectations from registries
Clinicians and patients needs and expectations from registries Luciano Vittozzi cnmr.eu@iss.it National Centre Rare Diseases National Institute for Health Rome Italy EPIRARE is a project co-funded by the
More informationJob Profile Clinical Research Associate III (CRA)
PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed
More informationA clinical research organization
A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced
More informationDomanda di innovazione nel mondo industriale. Modalità di interazione tra pubblico e privato
Domanda di innovazione nel mondo industriale. Modalità di interazione tra pubblico e privato Ennio Ongini Nicox Consiglio Nazionale delle Ricerche Quarta Giornata Informativa "Dalla ricerca al Trasferimento
More informationTargeting Cancer: Innovation in the Treatment of Chronic Myelogenous Leukemia EXECUTIVE SUMMARY. New England Healthcare Institute
Targeting Cancer: Innovation in the Treatment of Chronic Myelogenous Leukemia New England Healthcare Institute NEHI Innovation Series March 2004 Executive Summary From drugs and medical devices, to information
More information8970/15 FMA/AFG/cb 1 DG G 3 C
Council of the European Union Brussels, 19 May 2015 (OR. en) 8970/15 NOTE RECH 141 TELECOM 119 COMPET 228 IND 80 From: Permanent Representatives Committee (Part 1) To: Council No. prev. doc.: 8583/15 RECH
More informationIRDiRC & E-Rare update
IRDiRC & E-Rare update February 2014 14/02/2014 2014 -Fondation maladies rares IRDiRC: objectives and scope The International Rare Disease Research Consortium (IRDiRC) teams up researchers and organizations
More informationOrphan Pharma: pathfinders for an increasingly specialised industry
Orphan Pharma: pathfinders for an increasingly specialised industry Foreword We are continuing our series by profiling the R&D and Clinical Development leadership of European and North American specialty
More informationVaccines Researches for the Future:
ITMO Microbiologie et maladies infectieuses Vaccines Researches for the Future: The corevac initiative Pr Brigitte AUTRAN Institute Infection-Cancer-Immunity, UPMC, Paris Pr Jean François Delfraissy Institute
More informationToday s Health Research Is Tomorrow s Healthcare
Medical Research Charities Group La Touche House, 1 Grove Road, Dublin 6. Today s Health Research Is Tomorrow s Healthcare Medical Research Charities Group Pre-Budget Submission Budget 2011 The future
More informationHow To Develop Hydrogen Fuel Cells
EXECUTIVE SUMMARY 7 Executive Summary Innovation in energy technology has widespread implications for OECD economies. Although the energy sector accounts for a small share of GDP, the pervasive use of
More informationFINLAND ON A ROAD TOWARDS A MODERN LEGAL BIOBANKING INFRASTRUCTURE
Postrefereed, preprint version of the text published at European Journal of Health Law 2013(3)28994. Link to the publisher s website: http://www.brill.com/europeanjournalhealthlaw Sirpa Soini FINLAND ON
More informationDEVELOPING WORLD HEALTH PARTNERSHIPS DIRECTORY
DEVELOPING WORLD HEALTH PARTNERSHIPS DIRECTORY OVER 250 HEALTH PARTNERSHIPS THAT MAKE A DIFFERENCE TO PEOPLE S LIVES The global health community needs to overcome both new and current challenges in the
More informationNeuromuscular disorders Development of consensus for diagnosis and standards of care. Thomas Sejersen, Pediatric neurology
Neuromuscular disorders Development of consensus for diagnosis and standards of care Thomas Sejersen, Pediatric neurology What are neuromuscular disorders? How does the field of neuromuscular disorders
More informationEU Clinical Trials Register. www.clinicaltrialsregister.eu. An agency of the European Union
EU Clinical Trials Register www.clinicaltrialsregister.eu An agency of the European Union The EU Clinical Trials Register provides public access to information from the European Union (EU) clinical trial
More informationDissemination of the results of projects funded under the EU Public Health Programme and funding opportunities IPH, Dublin, 13 October 2015
Dissemination of the results of projects funded under the EU Public Health Programme and funding opportunities IPH, Dublin, 13 October 2015 Anne-Marie Yazbeck Project Officer, Chafea DG SANTE Policy Priorities
More informationCord blood banking: information for parents
Cord blood banking: information for parents Published August 2006 by the RCOG Contents Page number Key points 1 About this information 2 What is cord blood? 2 Why is cord blood useful? 3 How is cord blood
More informationNormand Laberge Vice-President Regulatory & Scientific Affairs Rx&D. Globalization of Clinical Research: Trends & Implications for Canada
Normand Laberge Vice-President Regulatory & Scientific Affairs Rx&D Globalization of Clinical Research: Trends & Implications for Success Rates by Phase and Therapeutic Area Source: Nature Reviews Drug
More informationThe Canadian Clinical Trials Asset Map (CCTAM) Jared Rhines,
The Canadian Clinical Trials Asset Map (CCTAM) Jared Rhines, Vice President, Scientifics and Strategic Affairs, Canada s Research-Based Pharmaceutical Companies (Rx&D) Global Patient Recruitment by Region
More informationELECTRONIC HEALTH RECORDS FOR CLINICAL RESEARCH
ELECTRONIC HEALTH RECORDS FOR CLINICAL RESEARCH! BioMedBridges Annual General Meeting! Dipak Kalra, EuroRec Christian Ohmann, ECRIN Electronic Health Records for Clinical Research! on behalf of the EHR4CR
More informationCareer Woman's Forum June 25th. Geneva Tourism & - How to market the destination!
Career Woman's Forum June 25th Geneva Tourism & - How to market the destination! 2 Geneva : a strong destination brand A very high spontaneous awareness 3 Jura Locarno Zermatt Davos Montreux Emmental Lugano
More informationThe Sage Group and Talentmark Consulting Announce Strategic Alliance for Services to the Global Healthcare & Life Sciences Industry
Talentmark Consulting Product Driven People Solutions Press Release The Sage Group and Talentmark Consulting Announce Strategic Alliance for Services to the Global Healthcare & Life Sciences Industry Cambridge
More informationWorkshop in view of the Hearings of Commissioner-Designates
DIRECTORATE GENERAL FOR INTERNAL POLICIES POLICY DEPARTMENT A: ECONOMIC AND SCIENTIFIC POLICY Environment, Public Health and Food Safety Committee Introductory Workshop Workshop in view of the Hearings
More informationECRIN European Clinical Research Infrastructure Network. www.ecrin.org
ECRIN European Clinical Research Infrastructure Network www.ecrin.org - support to investigators and sponsors in multinational studies Make Europe a single area for clinical research A pan-european infrastructure
More informationCLARA DAY ON OPERATIONS RESEARCH IN CANCER TREATMENT & OPERATION MANAGEMENT
CLARA DAY ON OPERATIONS RESEARCH IN CANCER TREATMENT & OPERATION MANAGEMENT November 17, 2010 SPEEDING UP PROGRESS Seven Cancer Research Networks within France Cancer in France Incidence 315,000 / year
More informationCertification of Electronic Health Record systems (EHR s)
Certification of Electronic Health Record systems (EHR s) The European Inventory of Quality Criteria Georges J.E. DE MOOR, M.D., Ph.D. EUROREC EuroRec The «European Institute for Health Records» A not-for-profit
More informationThe Global Connector. European Connected Health Alliance. Test beds in European Ecosystems Brian O Connor, Chair, ECHAlliance
European Connected Health Alliance Bringing Together the future of Health, Social Care & Wellness The Global Connector Test beds in European Ecosystems Brian O Connor, Chair, ECHAlliance www.echalliance.com
More informationNATIONAL POPULATION HEALTH STUDY OF NEUROLOGICAL CONDITIONS. Invitation To Submit A Letter Of Intent (LOI) Guide To Applicants
Enhanced Surveillance for Chronic Disease Program NATIONAL POPULATION HEALTH STUDY OF NEUROLOGICAL CONDITIONS Invitation To Submit A Letter Of Intent (LOI) Guide To Applicants January 2010 Table of Contents
More informationFrench National Agency for Medicines and Health Products Safety (ANSM) :
French National Agency for Medicines and Health Products Safety (ANSM) : Reinforcing the collaboration with healthcare professionals and patient associations Dany BONNET Scientific information manager
More informationDan D. Farcas. National Centre for Organizing and Ensuring the Health Information System (NCOEHIS),
Steps toward ehealth interoperability Dan D. Farcas National Centre for Organizing and Ensuring the Health Information System (NCOEHIS), str. George Vraca 9, Bucharest, Romania, dfarcas@ccss.ro Interoperability
More informationACRONIM : InNerMeD-I-Network. STARTING DATE: 2013-04-01 DURATION (in months): 30. PRIORITY AREA: Actions under the second objective 'Promote health'
IInherriitted NeuRoMettabolliic Diiseases IINFORMATIION NETWORK ACRONIM : InNerMeD-I-Network STARTING DATE: 2013-04-01 DURATION (in months): 30 PRIORITY AREA: Actions under the second objective 'Promote
More informationHorizon 2020 New Opportunities for Clinical Research in Europe
Horizon 2020 New Opportunities for Clinical Research in Europe Ruxandra Draghia Akli, MD, PhD Director, Health Research DG Research and Innovation European Commission Electronic Health Records for Clinical
More informationTranslational research infrastructure in Neurosciences 15.06.2011/Bruxelles
ITMO Neurosciences, sciences cognitives, neurologie, psychiatrie Translational research infrastructure in Neurosciences 15.06.2011/Bruxelles ITMO Technologie pour la santé 1 NEUROSCIENCE MEDICAL CHALLENGES
More informationEditorial. Yves Levy, Executive Director
Editorial Yves Levy, Executive Director I am delighted to announce the creation of a new research centre: the Vaccine Research Institute (VRI). The VRI addresses the unprecedented challenge of developing
More informationL: Pediatrics. College of Licensed Practical Nurses of Alberta, Competency Profile for LPNs, 3rd Ed. 109
L: Pediatrics College of Licensed Practical Nurses of Alberta, Competency Profile for LPNs, 3rd Ed. 109 Major Competency Area: L Pediatrics Competency: L-1 Pediatric Nursing Date: June 1, 2015 L-1-1 L-1-2
More informationEthics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015
Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient
More informationBioTuesday Introduction to Kendle. Philippe Moreau, CRA Manager
BioTuesday Introduction to Kendle Philippe Moreau, CRA Manager March 1, 2011 Overview Top-tier CRO uniquely positioned to deliver Phases I-IV 30-year track record of delivering on client expectations Partners
More informationThe EMA current activities towards ISO IDMP implementation
The EMA current activities towards ISO IDMP implementation An overview Ginas meeting 11 June 2014 Presented by: Ilaria Del Seppia, B-BD-DCM EMA An agency of the European Union Outlines EMA Vision: Objectives
More informationTransgene in 2007: Partnership and Refinancing Position the Company for its Future Development
Strasbourg, 11 March 2008 Transgene in 2007: Partnership and Refinancing Position the Company for its Future Development Strasbourg, France, March 11, 2008 Transgene (Euronext Paris: FR0005175080) announces
More informationmhealth and ehealth: Understanding the future of cancer care
ECPC General Assembly 2016 Brussels, Belgium 3-5 June 2016 mhealth and ehealth: Understanding the future of cancer care Dee O Sullivan Director myhealthapps.net/patientview About PatientView UK-based research,
More informationLocation for Trials- Global Considerations A Pharma Perspective. Carlo Maccarrone Assoc. Director, Clinical Research GSK Australia 7 May 2014
Location for Trials- Global Considerations A Pharma Perspective Carlo Maccarrone Assoc. Director, Clinical Research GSK Australia 7 May 2014 Why Choose Australia for Clinical Trials? What is he saying
More informationQuality and critical appraisal of clinical practice guidelines a relevant topic for health care?
Quality and critical appraisal of clinical practice guidelines a relevant topic for health care? Françoise Cluzeau, PhD St George s Hospital Medical School, London on behalf of the AGREE Collaboration
More informationEMA EFPIA workshop Break-out session no. 4
EMA EFPIA workshop Break-out session no. 4 Longitudinal model-based test as primary analysis in phase III B. Bieth*, D. Renard*, I. Demin*, B. Hamrén*, G. Heimann*, Sigrid Balser** * Modeling and Simulation,
More informationFSH Society s 2014 Biennial FSHD Connect Meeting: Natural History Studies
FSH Society s 2014 Biennial FSHD Connect Meeting: Natural History Studies Raymond A. Huml, MS, DVM, RAC Executive Director, Head, Global Biosimilars Business Development and Strategic Planning, Quintiles
More informationEffect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes: SCALE - Diabetes This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim
More informationBiotech Concerto #3. European Clinical Trial Environment
Biotech Concerto #3 European Clinical Trial Environment December 2008 Index EU Directive EU Approval System European Authority: EMEA The Guidance Documents Route Map Challenges EMEA Organization Chart
More informationRegulatory Writing Clinical Project Management Strategic Communications
Regulatory Writing Clinical Project Management Strategic Communications FLEXIBLE. STRATEGIC. INFORMED. COMPLIANT. For over 15 years, Niche Science and Technology has been providing outstanding medical
More informationEUROPLAN R E S P O N D I N G T O N O N-C O M M U N I C A BLE H E A L T H T H R E A T S
EUROPLAN EUROPEAN PROJECT FOR RARE DISEASES NATIONAL PLANS DEVELOPMENT F U N D E D: E U ROPEAN CO M M I S S I O N PU BLIC HEALTH P R O G R A M 2003-08 P RI ORITY A R E A: 1. HEALTH I N F O R M A T I O
More informationSharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com
SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,
More informationBreakthrough Therapy Program U.S. Food and Drug Administration (FDA)
Breakthrough Therapy Program U.S. Food and Drug Administration (FDA) Presentation before the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) Jarilyn Dupont,
More informationPatent Involvement in Clinical Research
PATIENT INVOLVEMENT IN CLINICAL RESEARCH A guide for Patient Organisations and Patient Representatives Produced by the PatientPartner project funded by the 7th Framework Programme of the European Commission
More informationREGULATORY ENVIRONMENT
1. Introduction REGULATORY ENVIRONMENT Research and development work, pre-clinical tests, clinical studies, facilities, and the manufacture and sale of the Company s products are and will continue to be
More informationAlain Schmitt Directorate General for Enterprise October 14 th, 2014
Alain Schmitt Directorate General for Enterprise October 14 th, 2014 I. Facts and figures about innovation in France II. Startup financing III. Entrepreneurship culture and ecosystems Worldwide ranking
More informationPLATFORM PARTNERS PARTNERS FOR INTERNATIONAL CLINICAL RESEARCHS
PLATFORM PARTNERS PARTNERS FOR INTERNATIONAL CLINICAL RESEARCHS Coordonnateurs : Pr Corinne Alberti Pr Éric Vicaut 1 WHO ARE WE? Units of Clinical Research APHP Inserm Partner 2 : Lariboisière Partner
More informationPolicy Recommendations for Managing Risk in Social Innovation
European Policy Brief Policy Recommendations for Managing Risk in Social Innovation LIPSE: Learning from Innovation in Public Sector Environments (Work Package 4) Sophie Flemig (University of Edinburgh)
More informationDiagnostic Tests. Brad Spring Director, Regulatory Affairs
Regulatory Challenges in the Development of Diagnostic Tests Industry Perspective Brad Spring Director, Regulatory Affairs September 28, 2011 Balancing Evidence of Safety & Effectiveness and Time to Market
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a COUNCIL RECOMMENDATION
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 22 July 2009 COM(2009) 379/3 Proposal for a COUNCIL RECOMMENDATION on measures to combat neurodegenerative diseases, in particular Alzheimer's, through
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, EMA Brussels, 27.03.2014 ENTR/6283/00 Rev 4 orphan\guidelines\format content
More informationEURORDIS Position Paper on Centres of Expertise and European Reference Networks for Rare Diseases
EURORDIS Position Paper on Centres of Expertise and European Reference Networks for Rare Diseases EURORDIS - the European Organisation for Rare Diseases represents 310 rare disease organisations from 34
More informationHoyer Lecture December 6,2013
Hoyer Lecture December 6,2013 Pediatric epilepsy: small steps, big challenges American Epilepsy Society Annual Meeting AES Salutes our Annual Meeting Volunteers Director, Education Council R. Edward Hogan,
More informationSTRATEGIC POLICY FORUM ON DIGITAL ENTREPRENEURSHIP. Fuelling Digital Entrepreneurship in Europe. Background paper
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Service Industries Key Enabling Technologies and Digital Economy Introduction STRATEGIC POLICY FORUM ON DIGITAL ENTREPRENEURSHIP Fuelling
More informationPersonalised Medicine what s in for Rare Diseases?
Personalised Medicine what s in for Rare Diseases? ICORD Ede, October 2014 Prof. Angela Brand MD PhD MPH a.brand@maastrichtuniversity.nl Institute for Public Health Genomics (IPHG), Maastricht University,
More information2015 Annual Report. How many phones have been added to GARI?
Annual Report 2015 The Global Accessibility Reporting Initiative in 2015 BACKGROUND Since the Global Accessibility Reporting Initiative (GARI) was established in 2008 by the Mobile Manufacturers Forum
More informationAdoption by CHMP for release for consultation November 2010. End of consultation (deadline for comments) 31 March 2011
1 2 3 November 2010 EMA/759784/2010 Committee for Medicinal Products for Human Use 4 5 6 7 Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and
More informationCareer Opportunities within the French Alliance for Life and Health Sciences
1 Career Opportunities within the French Alliance for Life and Health Sciences Mireille Guyader, PhD Director, Inserm-USA Office INSERM KEY FIGURES (Year 2013) Budget: 970 M (~ $1.2 Billion) Human resources:
More informationII. AREA OF INVOLVEMENT OF PATIENTS AND CONSUMERS IN EMEA ACTIVITIES
European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use MINUTES OF THE EIGHTH MEETING OF THE EMEA HUMAN SCIENTIFIC COMMITTEES WORKING PARTY WITH PATIENTS' AND CONSUMERS' ORGANISATIONS
More information