RAI
Amsterdam
Final day: Wednesday, Mar, 06 (51)
- Title: FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: HOW TO OPTIMISE CLINICAL DEVELOPMENT IN THE ELDERLY: SOME PRACTICAL EXAMPLES
Event Type: SESSION
Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALS
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: NEW OPPORTUNITIES FOR INFORMATION TECHNOLOGY IN PHARMACOVIGILANCE
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: QUALITY UPDATE - CURRENT DEVELOPMENTS
Event Type: SESSION
Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: LATEST US REGULATORY MOVES TOWARDS FOSTERING INNOVATION: UPDATE ON MAIN NEW AND REVISED REGULATIONS AND GUIDANCE
Event Type: SESSION
Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: KNOWN ACTIVE SUBSTANCES FOR THE SELF-CARE SECTOR
Event Type: SESSION
Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: INNOVATIVE APPROACHES TO PRODUCT INFORMATION FOR PHYSICIANS AND PATIENTS
Event Type: SESSION
Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: MNC’S EXPANSION IN EMERGING MARKETS: OPPORTUNITIES AND CHALLENGES
Event Type: SESSION
Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: A CASE STUDY USING THE FRAMEWORK SUPPORTED BY QUANTATATIVE METHODS FOR BENEFIT/RISK ASSESSMENT
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: NON-CLINICAL TESTING FOR ADVANCED THERAPY
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: FOCUS ON MEDICINES EFFICACY, SAFETY AND USAGE IN EDUCATION AND TRAINING
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: EMA ROUNDTABLE- SCIENTIFIC COMMITTEES UNITED IN DIVERSITY
Event Type: SESSION
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: SOCIAL MEDIA/USE OF TABLETS AND SMARTPHONES
Event Type: SESSION
Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM - Title: THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: PAEDIATRIC CLINICAL TRIALS – TRIAL BY DESIGN
Event Type: SESSION
Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED?
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: RISK COMMUNICATION AND TRANSPARENCY
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: ADOPTION OF GAME CHANGING TECHNOLOGIES
Event Type: SESSION
Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: INTERNATIONAL HARMONISATION: GLOBAL REGULATORS’ PROGRESS FROM GHTF TO IMDRF - ARE WE ANY NEARER TO REGULATORY CONVERGENCE?
Event Type: SESSION
Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTS
Event Type: SESSION
Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCE
Event Type: SESSION
Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS
Event Type: SESSION
Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: EQUIVALENCE OF ORALLY INHALED PRODUCTS
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: NEW TRENDS IN INVITRO NON-CLINICAL TESTING
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: QUALITY CAREER DEVELOPMENT IN GLOBAL MEDICINES DEVELOPMENT
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: JAPANESE REGULATORY SESSION – PMDA UPDATE
Event Type: SESSION
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: QUALITY RISK MANAGEMENT WORKSHOP
Event Type: WORKSHOP
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM - Title: THE PATIENTS’ PERSPECTIVE ON HTA
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: IMPACT OF ICH E2C (R2) AND GVP MODULE VII
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: PATIENT RECRUITMENT AND RETENTION
Event Type: SESSION
Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY
Event Type: SESSION
Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: HOW SYNERGY BETWEEN DATA MANAGEMENT AND TECHNOLOGY WILL DRIVE CLINICAL DEVELOPMENT IN THE NEXT DECADE
Event Type: SESSION
Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: COMBINATION MEDICINAL DRUG PRODUCTS OF KNOWN ACTIVE SUBSTANCES
Event Type: SESSION
Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: REGULATORY TOWN HALL MEETING
Event Type: SESSION
Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: SUBGROUP ANALYSES
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: NEW ICH INITIATIVES IN SAFETY TESTING
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - 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 PROCESS
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN
Event Type: SESSION
Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: PERSPECTIVES AND COLLABORATION BETWEEN PATIENTS AND STUDENTS
Event Type: SESSION
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM - Title: HTA AND OFF-LABEL USE
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: PAEDIATRIC REQUIREMENTS – DO THEY DELIVER AND AT WHICH COST?
Event Type: SESSION
Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: DEVELOPMENT OF PHARMACOVIGILANCE METHODOLOGY
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: COLLECTING RELEVANT HEALTH OUTCOME DATA
Event Type: SESSION
Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: HARMONISATION – PITFALLS AND HOW CAN WE SPEED IT UP?
Event Type: SESSION
Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: WHICH EU REGULATORY RULES FOR TELEMEDICINE, EHEALTH AND MHEALTH? HOW CAN INNOVATION BE ENCOURAGED?
Event Type: SESSION
Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: CLINICAL TRIALS IN EUROPE: WILL THE REVISED LEGISLATION MEET THE DEMANDS OF TOMORROW?
Event Type: SESSION
Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: STATISTICAL HOT TOPICS IN SCIENTIFIC ADVICE
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: OVERVIEW OF CURRENT DISCUSSIONS IN ICH
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM - Title: TOWARDS A EUROPEAN FRAMEWORK FOR CONTINUING PROFESSIONAL DEVELOPMENT IN A LIFE-LONG LEARNING PERSPECTIVE
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
