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Title: MAKING THE MOST OUT OF THE DIA EUROMEETING IN ORDER TO ENTER THE INDUSTRYEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: Tutorial 01: Highlights on the Implementation of the New Pharmacovigilance Legislation with regards to Adverse Reaction Reporting Rules, Use of New International Standards and Signal Management in EudravigilanceEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 02: Analysis of Safety Data from Clinical TrialsEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 03: Update on Practical Work with Variation RegulationEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 04: Introduction to Medical Device RegulationEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 05: Recent and Current developments in Pharmaceutical LawEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 07: The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committeeof the European Medicnies AgencyEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 08: Health Technology Assessment of Drugs and Medical DevicesEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 09: The European QP for Pharmacovigilance: Everything you ever Wanted to know but were afraid to askEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 10: Non-Clinical Safety Assessment in Global Pharmaceutical Development Event Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 11: Interactions between Regulatory and Intellectual Property, Privacy and Product LiabilityEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 12: Development Safety Update Report (DSUR) Kick-off in 2011: Then and KnowEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 13: Technology Transfer for Biopharmaceuticals WorkshopEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 14: Pharmacovigilance Audits and InspectionsEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 15: Coding with ConfidenceEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 16: Understanding Translational Medicine: Benefits and Innovative Approaches Event Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Tutorial 17: Creating Compliant Clinical Study Reports for the EU and USEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: Roundtable 01: GCP Inspections and Audit FindingsEvent Type: TUTORIALTracks: Tutorials - Pre-conference tutorials
Title: YOUNG PROFESSIONALS IN THE PHARMACEUTICAL INDUSTRYEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: ENHANCING YOUR SOFT SKILLS BY IMPROVING YOUR EMOTIONAL INTELLIGENCE (EQ)Event Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: Opening Plenary: Public/Private Partnerships: Working together in the interest of patientsEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: MECHANISM OF ACTION - THE LEADING PARADIGMEvent Type: SESSIONTracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
Title: REGULATORY DATA PROTECTIONEvent Type: SESSIONTracks: Theme 03 - Legal/Transparency-Risk Assessment
Title: IMPLEMENTATION OF THE NEW PHARMACOVIGILANCE LEGISLATIONEvent Type: SESSIONTracks: Theme 04 - Pharmacovigilance
Title: NEW APPROACHES FOR MONITORING Event Type: SESSIONTracks: Theme 05 - Clinical Research and Development
Title: DRUG SHORTAGE MANAGEMENT- ENSURING MEDICINE SUPPLY Event Type: SESSIONTracks: Theme 06 - Quality (including Falsified Medicines)
Title: CURRENT STATUS OF REVISION OF EU MEDICAL DEVICE DIRECTIVES: THE KEY THEMES AND CONTROVERSIES Event Type: SESSIONTracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
Title: MIGRATION FROM PAPER TO ELECTRONICEvent Type: SESSIONTracks: Theme 08 - eTools and Data Management
Title: LEARNED SOCIETIES AND DRUG REGULATION Event Type: SESSIONTracks: Theme 09 - Involvement of Patients and Academia as Experts in the Drug Approval Process
Title: NEW RULES FOR ASSESSMENT OF KNOWN ACTIVE SUBSTANCESEvent Type: SESSIONTracks: Theme 10 - Known Active Substances
Title: BOTTLENECKS IN RESEARCH: HOW DO WE REPLENISH THE PIPELINE?Event Type: SESSIONTracks: Theme 11 - Effective Antibacterials: The present and the future
Title: THE EU DRUG DEVELOPMENT AND APPROVAL SYSTEM: ADAPTING THE FRAMEWORK OF DRUG DEVELOPMENT AND APPROVALS TO ENABLE R&D INNOVATION AND SUPPORT SOCIETAL NEEDS - AN OUTLOOK ON THE CHANGING ENVIRONMENT FOR 2020Event Type: SESSIONTracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
Title: SAFE, EFFECTIVE AND AFFORDABLE MEDICINAL PRODUCTS FOR A GLOBAL POPULATIONEvent Type: SESSIONTracks: Theme 13 - Globalisation
Title: SETTING THE SCENE: IMPORTANCE OF REGULATORY SCIENCE THROUGHOUTEvent Type: SESSIONTracks: Theme 14 - Regulatory Science
Title: PUBLIC PRIVATE PARTNERSHIP FOR BIOMEDICAL RESEARCH UNDER HORIZON 2020: PATIENTS’ PERSPECTIVE ON SCIENTIFIC PRIORITIESEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: THE EUROPEAN LANDSCAPE ON HTA - THE EUnetHTA JOINT ACTIONEvent Type: SESSIONTracks: Theme 01 - HTA/Sustainability of Health Systems in Europe
Title: COHORT STUDIES OF THE ELDERLY AS A TOOL FOR DRUG DEVELOPMENT AND TESTINGEvent Type: SESSIONTracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
Title: INCENTIVES FOR PAEDIATRIC CLINICAL RESEARCHEvent Type: SESSIONTracks: Theme 03 - Legal/Transparency-Risk Assessment
Title: BENEFIT/RISK MANAGEMENT IN PHARMACOVIGILANCEEvent Type: SESSIONTracks: Theme 04 - Pharmacovigilance
Title: BEST PRACTICES IN PHARMACOVIGILANCE GOVERNANCEEvent Type: SESSIONTracks: Theme 04 - Pharmacovigilance
Title: WHY TRIALS FAIL AND HOW TO PREVENT THISEvent Type: SESSIONTracks: Theme 05 - Clinical Research and Development
Title: THE EU QUALIFIED PERSON IN A GLOBAL ENVIRONMENT Event Type: SESSIONTracks: Theme 06 - Quality (including Falsified Medicines)
Title: DEVELOPMENT AND REGULATORY FRAMEWORK FOR COMPANION DIAGNOSTICS Event Type: SESSIONTracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
Title: CLINICAL STANDARDS AND METADATAEvent Type: SESSIONTracks: Theme 08 - eTools and Data Management
Title: PATIENTS AS EXPERTS IN DRUG REGULATIONEvent Type: SESSIONTracks: Theme 09 - Involvement of Patients and Academia as Experts in the Drug Approval Process
Title: HARMONISATION: CHALLENGES IN PRODUCT INFORMATION / LABELLING Event Type: SESSIONTracks: Theme 10 - Known Active Substances
Title: PRAGMATIC REGULATION - ROLE OF GUIDELINES IN STIMULATING DEVELOPMENT OF NEW ANTIBIOTICS Event Type: SESSIONTracks: Theme 11 - Effective Antibacterials: The present and the future
Title: INTERNATIONAL COLLABORATION IN THE REVIEW OF GENERIC DRUGSEvent Type: SESSIONTracks: Theme 13 - Globalisation
Title: THE WAY FORWARD IN CNS: REGULATORY SCIENCE AT THE EDGEEvent Type: SESSIONTracks: Theme 14 - Regulatory Science
Title: COMPARATIVE EFFECTIVENESS AS PART OF THE PUBLIC ASSESSMENT REPORT (PAR)Event Type: SESSIONTracks: Theme 01 - HTA/Sustainability of Health Systems in Europe
Title: CANCELLED: DEVELOPMENT OF INNOVATIVE INTERVENTIONS FOR HEALTHY AGEING: HOW FAR DID WE GET?Event Type: SESSIONTracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
Title: LEGAL COMPLIANCE FOR REGULATORY FUNCTIONS - LEARNINGS FROM RECENT ENFORCEMENT ACTIVITIESEvent Type: SESSIONTracks: Theme 03 - Legal/Transparency-Risk Assessment
Title: ENHANCING CLINICAL RESEARCH EFFECTIVENESS Event Type: SESSIONTracks: Theme 05 - Clinical Research and Development
Title: FALSIFIED MEDICINES DIRECTIVE AND ACTIVE SUBSTANCESEvent Type: SESSIONTracks: Theme 06 - Quality (including Falsified Medicines)
Title: CHANGES IN EU APPROVAL OF DRUG/DEVICE COMBINATIONS – THE NEW REGULATORY STRUCTURE AND HOW IT WILL IMPACT INNOVATIONEvent Type: SESSIONTracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
Title: PHARMACOVIGILANCE AND MEDICINAL PRODUCT STANDARDS AND METADATAEvent Type: SESSIONTracks: Theme 08 - eTools and Data Management
Title: MAINTENANCE OF MEDICINAL PRODUCTS WITH KNOWN ACTIVE SUBSTANCES – VARIATIONSEvent Type: SESSIONTracks: Theme 10 - Known Active Substances
Title: PRESERVING WHAT WE HAVE - PRUDENT AND CONTROLLED USEEvent Type: SESSIONTracks: Theme 11 - Effective Antibacterials: The present and the future
Title: FIRST EXPERIENCE WITH THE PHARMACOVIGILANCE LEGISLATIONEvent Type: SESSIONTracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
Title: SFDA SESSION - GMP IN CHINAEvent Type: SESSIONTracks: Theme 13 - Globalisation
Title: THE ESCHER PROJECT: REGULATORY SCIENCE IN PRACTICE Event Type: SESSIONTracks: Theme 14 - Regulatory Science
Title: ELECTRONIC HEALTH RECORDSEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: CANCELLED: HTA AND PRICING POLICIES IN EU AFTER THE TRANSPARENCY DIRECTIVEEvent Type: SESSIONTracks: Theme 01 - HTA/Sustainability of Health Systems in Europe
Title: BIOSIMILARSEvent Type: SESSIONTracks: Theme 03 - Legal/Transparency-Risk Assessment
Title: ADAPTIVE CLINICAL TRIAL DESIGNS Event Type: SESSIONTracks: Theme 05 - Clinical Research and Development
Title: FALSIFIED MEDICINES DIRECTIVE AND SERIALISATIONEvent Type: SESSIONTracks: Theme 06 - Quality (including Falsified Medicines)
Title: HOW TO ADDRESS DIFFERENT REQUIREMENTS DEVELOPING COMBINATION PRODUCTS: THE CHALLENGES OF MANAGING TWO SETS OF RULESEvent Type: SESSIONTracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
Title: MESSAGES FROM THE AGENCIESEvent Type: SESSIONTracks: Theme 08 - eTools and Data Management
Title: HANDLING CONFLICT OF INTEREST (COI) Event Type: SESSIONTracks: Theme 09 - Involvement of Patients and Academia as Experts in the Drug Approval Process
Title: XEVMPD: LONG-TERM EXPECTATIONS AND BENEFITSEvent Type: SESSIONTracks: Theme 10 - Known Active Substances
Title: NEW APPROACHES TO COMBAT RESISTANCEEvent Type: SESSIONTracks: Theme 11 - Effective Antibacterials: The present and the future
Title: EARLY DIALOGUE IN DRUG DEVELOPMENTEvent Type: SESSIONTracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
Title: PATIENT AND CONSUMER ROLES: THEIR INPUT IN REGULATORY SCIENCEEvent Type: SESSIONTracks: Theme 14 - Regulatory Science
Title: GCP HOT TOPICS: THE CHALLENGES IN THE CRO-SPONSOR RELATIONSHIPEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: PHARMACEUTICAL LAW IN THE NETHERLANDS: BUILDING AN EU ASSOCIATION?Event Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)Event Type: SESSIONTracks: Theme 01 - HTA/Sustainability of Health Systems in Europe
Title: HOW TO OPTIMISE CLINICAL DEVELOPMENT IN THE ELDERLY: SOME PRACTICAL EXAMPLESEvent Type: SESSIONTracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
Title: FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALSEvent Type: SESSIONTracks: Theme 03 - Legal/Transparency-Risk Assessment
Title: NEW OPPORTUNITIES FOR INFORMATION TECHNOLOGY IN PHARMACOVIGILANCEEvent Type: SESSIONTracks: Theme 04 - Pharmacovigilance
Title: QUALITY UPDATE - CURRENT DEVELOPMENTSEvent Type: SESSIONTracks: Theme 06 - Quality (including Falsified Medicines)
Title: LATEST US REGULATORY MOVES TOWARDS FOSTERING INNOVATION: UPDATE ON MAIN NEW AND REVISED REGULATIONS AND GUIDANCEEvent Type: SESSIONTracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
Title: SOCIAL MEDIA/USE OF TABLETS AND SMARTPHONESEvent Type: SESSIONTracks: Theme 08 - eTools and Data Management
Title: KNOWN ACTIVE SUBSTANCES FOR THE SELF-CARE SECTOR Event Type: SESSIONTracks: Theme 10 - Known Active Substances
Title: INNOVATIVE APPROACHES TO PRODUCT INFORMATION FOR PHYSICIANS AND PATIENTSEvent Type: SESSIONTracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
Title: MNC’S EXPANSION IN EMERGING MARKETS: OPPORTUNITIES AND CHALLENGESEvent Type: SESSIONTracks: Theme 13 - Globalisation
Title: A CASE STUDY USING THE FRAMEWORK SUPPORTED BY QUANTATATIVE METHODS FOR BENEFIT/RISK ASSESSMENTEvent Type: SESSIONTracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
Title: NON-CLINICAL TESTING FOR ADVANCED THERAPYEvent Type: SESSIONTracks: Theme 16 - Non-Clinical
Title: FOCUS ON MEDICINES EFFICACY, SAFETY AND USAGE IN EDUCATION AND TRAININGEvent Type: SESSIONTracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
Title: EMA ROUNDTABLE- SCIENTIFIC COMMITTEES UNITED IN DIVERSITYEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTASEvent Type: SESSIONTracks: Theme 01 - HTA/Sustainability of Health Systems in Europe
Title: PAEDIATRIC CLINICAL TRIALS – TRIAL BY DESIGNEvent Type: SESSIONTracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
Title: TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED? Event Type: SESSIONTracks: Theme 03 - Legal/Transparency-Risk Assessment
Title: RISK COMMUNICATION AND TRANSPARENCYEvent Type: SESSIONTracks: Theme 04 - Pharmacovigilance
Title: ADOPTION OF GAME CHANGING TECHNOLOGIESEvent Type: SESSIONTracks: Theme 05 - Clinical Research and Development
Title: INTERNATIONAL HARMONISATION: GLOBAL REGULATORS’ PROGRESS FROM GHTF TO IMDRF - ARE WE ANY NEARER TO REGULATORY CONVERGENCE?Event Type: SESSIONTracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
Title: ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTSEvent Type: SESSIONTracks: Theme 08 - eTools and Data Management
Title: BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCEEvent Type: SESSIONTracks: Theme 10 - Known Active Substances
Title: ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTSEvent Type: SESSIONTracks: Theme 13 - Globalisation
Title: EQUIVALENCE OF ORALLY INHALED PRODUCTSEvent Type: SESSIONTracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
Title: NEW TRENDS IN INVITRO NON-CLINICAL TESTINGEvent Type: SESSIONTracks: Theme 16 - Non-Clinical
Title: QUALITY CAREER DEVELOPMENT IN GLOBAL MEDICINES DEVELOPMENTEvent Type: SESSIONTracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
Title: JAPANESE REGULATORY SESSION – PMDA UPDATEEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: QUALITY RISK MANAGEMENT WORKSHOPEvent Type: WORKSHOPTracks: Theme 18 - Stand-Alone Sessions
Title: THE PATIENTS’ PERSPECTIVE ON HTAEvent Type: SESSIONTracks: Theme 01 - HTA/Sustainability of Health Systems in Europe
Title: LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USEEvent Type: SESSIONTracks: Theme 03 - Legal/Transparency-Risk Assessment
Title: IMPACT OF ICH E2C (R2) AND GVP MODULE VII Event Type: SESSIONTracks: Theme 04 - Pharmacovigilance
Title: PATIENT RECRUITMENT AND RETENTIONEvent Type: SESSIONTracks: Theme 05 - Clinical Research and Development
Title: PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORYEvent Type: SESSIONTracks: Theme 06 - Quality (including Falsified Medicines)
Title: HOW SYNERGY BETWEEN DATA MANAGEMENT AND TECHNOLOGY WILL DRIVE CLINICAL DEVELOPMENT IN THE NEXT DECADE Event Type: SESSIONTracks: Theme 08 - eTools and Data Management
Title: COMBINATION MEDICINAL DRUG PRODUCTS OF KNOWN ACTIVE SUBSTANCESEvent Type: SESSIONTracks: Theme 10 - Known Active Substances
Title: REGULATORY TOWN HALL MEETINGEvent Type: SESSIONTracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
Title: ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN Event Type: SESSIONTracks: Theme 13 - Globalisation
Title: SUBGROUP ANALYSESEvent Type: SESSIONTracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
Title: NEW ICH INITIATIVES IN SAFETY TESTINGEvent Type: SESSIONTracks: Theme 16 - Non-Clinical
Title: EUPATI - THE EUROPEAN PATIENTS ACADEMY ON THERAPEUTIC INNOVATION – AN UNPRECEDENTED PUBLIC PRIVATE PARTNERSHIP TO EMPOWER PATIENTS TO ENGAGE AS REAL PARTNERS IN THE DRUG DEVELOPMENT PROCESSEvent Type: SESSIONTracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
Title: PERSPECTIVES AND COLLABORATION BETWEEN PATIENTS AND STUDENTSEvent Type: SESSIONTracks: Theme 18 - Stand-Alone Sessions
Title: HTA AND OFF-LABEL USE Event Type: SESSIONTracks: Theme 01 - HTA/Sustainability of Health Systems in Europe
Title: PAEDIATRIC REQUIREMENTS – DO THEY DELIVER AND AT WHICH COST?Event Type: SESSIONTracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
Title: DEVELOPMENT OF PHARMACOVIGILANCE METHODOLOGYEvent Type: SESSIONTracks: Theme 04 - Pharmacovigilance
Title: COLLECTING RELEVANT HEALTH OUTCOME DATA Event Type: SESSIONTracks: Theme 05 - Clinical Research and Development
Title: HARMONISATION – PITFALLS AND HOW CAN WE SPEED IT UP?Event Type: SESSIONTracks: Theme 06 - Quality (including Falsified Medicines)
Title: WHICH EU REGULATORY RULES FOR TELEMEDICINE, EHEALTH AND MHEALTH? HOW CAN INNOVATION BE ENCOURAGED?Event Type: SESSIONTracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
Title: CLINICAL TRIALS IN EUROPE: WILL THE REVISED LEGISLATION MEET THE DEMANDS OF TOMORROW?Event Type: SESSIONTracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
Title: STATISTICAL HOT TOPICS IN SCIENTIFIC ADVICEEvent Type: SESSIONTracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
Title: OVERVIEW OF CURRENT DISCUSSIONS IN ICHEvent Type: SESSIONTracks: Theme 16 - Non-Clinical
Title: TOWARDS A EUROPEAN FRAMEWORK FOR CONTINUING PROFESSIONAL DEVELOPMENT IN A LIFE-LONG LEARNING PERSPECTIVEEvent Type: SESSIONTracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients