|
MAKING THE MOST OUT OF THE DIA EUROMEETING IN ORDER TO ENTER THE INDUSTRY
|
SESSION
|
Monday, Mar 04
|
9:00AM - 10:30AM
|
Theme 18 - Stand-Alone Sessions
|
|
|
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 Eudravigilance
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 02: Analysis of Safety Data from Clinical Trials
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 03: Update on Practical Work with Variation Regulation
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 04: Introduction to Medical Device Regulation
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 05: Recent and Current developments in Pharmaceutical Law
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 07: The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committeeof the European Medicnies Agency
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 08: Health Technology Assessment of Drugs and Medical Devices
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 09: The European QP for Pharmacovigilance: Everything you ever Wanted to know but were afraid to ask
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 10: Non-Clinical Safety Assessment in Global Pharmaceutical Development
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 11: Interactions between Regulatory and Intellectual Property, Privacy and Product Liability
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 12: Development Safety Update Report (DSUR) Kick-off in 2011: Then and Know
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 13: Technology Transfer for Biopharmaceuticals Workshop
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 14: Pharmacovigilance Audits and Inspections
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 15: Coding with Confidence
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 16: Understanding Translational Medicine: Benefits and Innovative Approaches
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Tutorial 17: Creating Compliant Clinical Study Reports for the EU and US
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
Roundtable 01: GCP Inspections and Audit Findings
|
TUTORIAL
|
Monday, Mar 04
|
9:00AM - 12:30PM
|
Tutorials - Pre-conference tutorials
|
|
|
YOUNG PROFESSIONALS IN THE PHARMACEUTICAL INDUSTRY
|
SESSION
|
Monday, Mar 04
|
11:00AM - 12:30PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
ENHANCING YOUR SOFT SKILLS BY IMPROVING YOUR EMOTIONAL INTELLIGENCE (EQ)
|
SESSION
|
Monday, Mar 04
|
11:00AM - 12:30PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
Opening Plenary: Public/Private Partnerships: Working together in the interest of patients
|
SESSION
|
Monday, Mar 04
|
3:40PM - 5:15PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
MECHANISM OF ACTION - THE LEADING PARADIGM
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
|
|
|
REGULATORY DATA PROTECTION
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 03 - Legal/Transparency-Risk Assessment
|
|
|
IMPLEMENTATION OF THE NEW PHARMACOVIGILANCE LEGISLATION
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 04 - Pharmacovigilance
|
|
|
NEW APPROACHES FOR MONITORING
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 05 - Clinical Research and Development
|
|
|
DRUG SHORTAGE MANAGEMENT- ENSURING MEDICINE SUPPLY
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 06 - Quality (including Falsified Medicines)
|
|
|
CURRENT STATUS OF REVISION OF EU MEDICAL DEVICE DIRECTIVES: THE KEY THEMES AND CONTROVERSIES
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
|
|
|
MIGRATION FROM PAPER TO ELECTRONIC
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 08 - eTools and Data Management
|
|
|
LEARNED SOCIETIES AND DRUG REGULATION
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 09 - Involvement of Patients and Academia as Experts in the Drug Approval Process
|
|
|
NEW RULES FOR ASSESSMENT OF KNOWN ACTIVE SUBSTANCES
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 10 - Known Active Substances
|
|
|
BOTTLENECKS IN RESEARCH: HOW DO WE REPLENISH THE PIPELINE?
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 11 - Effective Antibacterials: The present and the future
|
|
|
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 2020
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
|
|
|
SAFE, EFFECTIVE AND AFFORDABLE MEDICINAL PRODUCTS FOR A GLOBAL POPULATION
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 13 - Globalisation
|
|
|
SETTING THE SCENE: IMPORTANCE OF REGULATORY SCIENCE THROUGHOUT
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 14 - Regulatory Science
|
|
|
PUBLIC PRIVATE PARTNERSHIP FOR BIOMEDICAL RESEARCH UNDER HORIZON 2020: PATIENTS’ PERSPECTIVE ON SCIENTIFIC PRIORITIES
|
SESSION
|
Tuesday, Mar 05
|
9:00AM - 10:30AM
|
Theme 18 - Stand-Alone Sessions
|
|
|
THE EUROPEAN LANDSCAPE ON HTA - THE EUnetHTA JOINT ACTION
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 01 - HTA/Sustainability of Health Systems in Europe
|
|
|
COHORT STUDIES OF THE ELDERLY AS A TOOL FOR DRUG DEVELOPMENT AND TESTING
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
|
|
|
INCENTIVES FOR PAEDIATRIC CLINICAL RESEARCH
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 03 - Legal/Transparency-Risk Assessment
|
|
|
BENEFIT/RISK MANAGEMENT IN PHARMACOVIGILANCE
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 04 - Pharmacovigilance
|
|
|
BEST PRACTICES IN PHARMACOVIGILANCE GOVERNANCE
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 04 - Pharmacovigilance
|
|
|
WHY TRIALS FAIL AND HOW TO PREVENT THIS
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 05 - Clinical Research and Development
|
|
|
THE EU QUALIFIED PERSON IN A GLOBAL ENVIRONMENT
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 06 - Quality (including Falsified Medicines)
|
|
|
DEVELOPMENT AND REGULATORY FRAMEWORK FOR COMPANION DIAGNOSTICS
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
|
|
|
CLINICAL STANDARDS AND METADATA
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 08 - eTools and Data Management
|
|
|
PATIENTS AS EXPERTS IN DRUG REGULATION
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 09 - Involvement of Patients and Academia as Experts in the Drug Approval Process
|
|
|
HARMONISATION: CHALLENGES IN PRODUCT INFORMATION / LABELLING
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 10 - Known Active Substances
|
|
|
PRAGMATIC REGULATION - ROLE OF GUIDELINES IN STIMULATING DEVELOPMENT OF NEW ANTIBIOTICS
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 11 - Effective Antibacterials: The present and the future
|
|
|
INTERNATIONAL COLLABORATION IN THE REVIEW OF GENERIC DRUGS
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 13 - Globalisation
|
|
|
THE WAY FORWARD IN CNS: REGULATORY SCIENCE AT THE EDGE
|
SESSION
|
Tuesday, Mar 05
|
11:00AM - 12:30PM
|
Theme 14 - Regulatory Science
|
|
|
COMPARATIVE EFFECTIVENESS AS PART OF THE PUBLIC ASSESSMENT REPORT (PAR)
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 01 - HTA/Sustainability of Health Systems in Europe
|
|
|
COMPARATIVE EFFECTIVENESS AS PART OF THE PUBLIC ASSESSMENT REPORT (PAR)
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 01 - HTA/Sustainability of Health Systems in Europe
|
|
|
CANCELLED: DEVELOPMENT OF INNOVATIVE INTERVENTIONS FOR HEALTHY AGEING: HOW FAR DID WE GET?
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
|
|
|
LEGAL COMPLIANCE FOR REGULATORY FUNCTIONS - LEARNINGS FROM RECENT ENFORCEMENT ACTIVITIES
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 03 - Legal/Transparency-Risk Assessment
|
|
|
ENHANCING CLINICAL RESEARCH EFFECTIVENESS
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 05 - Clinical Research and Development
|
|
|
FALSIFIED MEDICINES DIRECTIVE AND ACTIVE SUBSTANCES
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 06 - Quality (including Falsified Medicines)
|
|
|
CHANGES IN EU APPROVAL OF DRUG/DEVICE COMBINATIONS – THE NEW REGULATORY STRUCTURE AND HOW IT WILL IMPACT INNOVATION
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
|
|
|
PHARMACOVIGILANCE AND MEDICINAL PRODUCT STANDARDS AND METADATA
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 08 - eTools and Data Management
|
|
|
MAINTENANCE OF MEDICINAL PRODUCTS WITH KNOWN ACTIVE SUBSTANCES – VARIATIONS
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 10 - Known Active Substances
|
|
|
PRESERVING WHAT WE HAVE - PRUDENT AND CONTROLLED USE
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 11 - Effective Antibacterials: The present and the future
|
|
|
FIRST EXPERIENCE WITH THE PHARMACOVIGILANCE LEGISLATION
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
|
|
|
SFDA SESSION - GMP IN CHINA
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 13 - Globalisation
|
|
|
THE ESCHER PROJECT: REGULATORY SCIENCE IN PRACTICE
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 14 - Regulatory Science
|
|
|
ELECTRONIC HEALTH RECORDS
|
SESSION
|
Tuesday, Mar 05
|
2:00PM - 3:30PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
CANCELLED: HTA AND PRICING POLICIES IN EU AFTER THE TRANSPARENCY DIRECTIVE
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 01 - HTA/Sustainability of Health Systems in Europe
|
|
|
BIOSIMILARS
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 03 - Legal/Transparency-Risk Assessment
|
|
|
ADAPTIVE CLINICAL TRIAL DESIGNS
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 05 - Clinical Research and Development
|
|
|
FALSIFIED MEDICINES DIRECTIVE AND SERIALISATION
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 06 - Quality (including Falsified Medicines)
|
|
|
HOW TO ADDRESS DIFFERENT REQUIREMENTS DEVELOPING COMBINATION PRODUCTS: THE CHALLENGES OF MANAGING TWO SETS OF RULES
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
|
|
|
MESSAGES FROM THE AGENCIES
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 08 - eTools and Data Management
|
|
|
HANDLING CONFLICT OF INTEREST (COI)
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 09 - Involvement of Patients and Academia as Experts in the Drug Approval Process
|
|
|
XEVMPD: LONG-TERM EXPECTATIONS AND BENEFITS
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 10 - Known Active Substances
|
|
|
NEW APPROACHES TO COMBAT RESISTANCE
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 11 - Effective Antibacterials: The present and the future
|
|
|
EARLY DIALOGUE IN DRUG DEVELOPMENT
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
|
|
|
PATIENT AND CONSUMER ROLES: THEIR INPUT IN REGULATORY SCIENCE
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 14 - Regulatory Science
|
|
|
GCP HOT TOPICS: THE CHALLENGES IN THE CRO-SPONSOR RELATIONSHIP
|
SESSION
|
Tuesday, Mar 05
|
4:00PM - 5:30PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
PHARMACEUTICAL LAW IN THE NETHERLANDS: BUILDING AN EU ASSOCIATION?
|
SESSION
|
Tuesday, Mar 05
|
6:00PM - 7:30PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 01 - HTA/Sustainability of Health Systems in Europe
|
|
|
HOW TO OPTIMISE CLINICAL DEVELOPMENT IN THE ELDERLY: SOME PRACTICAL EXAMPLES
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
|
|
|
FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION
L TRIALS
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 03 - Legal/Transparency-Risk Assessment
|
|
|
NEW OPPORTUNITIES FOR INFORMATION TECHNOLOGY IN PHARMACOVIGILANCE
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 04 - Pharmacovigilance
|
|
|
QUALITY UPDATE - CURRENT DEVELOPMENTS
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 06 - Quality (including Falsified Medicines)
|
|
|
LATEST US REGULATORY MOVES TOWARDS FOSTERING INNOVATION: UPDATE ON MAIN NEW AND REVISED REGULATIONS AND GUIDANCE
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
|
|
|
SOCIAL MEDIA/USE OF TABLETS AND SMARTPHONES
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 08 - eTools and Data Management
|
|
|
KNOWN ACTIVE SUBSTANCES FOR THE SELF-CARE SECTOR
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 10 - Known Active Substances
|
|
|
INNOVATIVE APPROACHES TO PRODUCT INFORMATION FOR PHYSICIANS AND PATIENTS
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
|
|
|
MNC’S EXPANSION IN EMERGING MARKETS: OPPORTUNITIES AND CHALLENGES
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 13 - Globalisation
|
|
|
A CASE STUDY USING THE FRAMEWORK SUPPORTED BY QUANTATATIVE METHODS FOR BENEFIT/RISK ASSESSMENT
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
|
|
|
NON-CLINICAL TESTING FOR ADVANCED THERAPY
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 16 - Non-Clinical
|
|
|
FOCUS ON MEDICINES EFFICACY, SAFETY AND USAGE IN EDUCATION AND TRAINING
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
|
|
|
EMA ROUNDTABLE- SCIENTIFIC COMMITTEES UNITED IN DIVERSITY
|
SESSION
|
Wednesday, Mar 06
|
9:00AM - 10:30AM
|
Theme 18 - Stand-Alone Sessions
|
|
|
THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 01 - HTA/Sustainability of Health Systems in Europe
|
|
|
PAEDIATRIC CLINICAL TRIALS – TRIAL BY DESIGN
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
|
|
|
TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED?
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 03 - Legal/Transparency-Risk Assessment
|
|
|
RISK COMMUNICATION AND TRANSPARENCY
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 04 - Pharmacovigilance
|
|
|
ADOPTION OF GAME CHANGING TECHNOLOGIES
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 05 - Clinical Research and Development
|
|
|
INTERNATIONAL HARMONISATION: GLOBAL REGULATORS’ PROGRESS FROM GHTF TO IMDRF - ARE WE ANY NEARER TO REGULATORY CONVERGENCE?
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
|
|
|
ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTS
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 08 - eTools and Data Management
|
|
|
BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCE
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 10 - Known Active Substances
|
|
|
ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 13 - Globalisation
|
|
|
EQUIVALENCE OF ORALLY INHALED PRODUCTS
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
|
|
|
NEW TRENDS IN INVITRO NON-CLINICAL TESTING
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 16 - Non-Clinical
|
|
|
QUALITY CAREER DEVELOPMENT IN GLOBAL MEDICINES DEVELOPMENT
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
|
|
|
JAPANESE REGULATORY SESSION – PMDA UPDATE
|
SESSION
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
QUALITY RISK MANAGEMENT WORKSHOP
|
WORKSHOP
|
Wednesday, Mar 06
|
11:00AM - 12:30PM
|
Theme 18 - Stand-Alone Sessions
|
|
|
THE PATIENTS’ PERSPECTIVE ON HTA
|
SESSION
|
Wednesday, Mar 06
|
2:00PM - 3:30PM
|
Theme 01 - HTA/Sustainability of Health Systems in Europe
|
|
|
LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE
|
SESSION
|
Wednesday, Mar 06
|
2:00PM - 3:30PM
|
Theme 03 - Legal/Transparency-Risk Assessment
|
|
|
IMPACT OF ICH E2C (R2) AND GVP MODULE VII
|
SESSION
|
Wednesday, Mar 06
|
2:00PM - 3:30PM
|
Theme 04 - Pharmacovigilance
|
|
|
PATIENT RECRUITMENT AND RETENTION
|
SESSION
|
Wednesday, Mar 06
|
2:00PM - 3:30PM
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Theme 05 - Clinical Research and Development
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PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 06 - Quality (including Falsified Medicines)
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HOW SYNERGY BETWEEN DATA MANAGEMENT AND TECHNOLOGY WILL DRIVE CLINICAL DEVELOPMENT IN THE NEXT DECADE
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 08 - eTools and Data Management
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COMBINATION MEDICINAL DRUG PRODUCTS OF KNOWN ACTIVE SUBSTANCES
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 10 - Known Active Substances
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REGULATORY TOWN HALL MEETING
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
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ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 13 - Globalisation
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SUBGROUP ANALYSES
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
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NEW ICH INITIATIVES IN SAFETY TESTING
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 16 - Non-Clinical
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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
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
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PERSPECTIVES AND COLLABORATION BETWEEN PATIENTS AND STUDENTS
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SESSION
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Wednesday, Mar 06
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2:00PM - 3:30PM
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Theme 18 - Stand-Alone Sessions
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HTA AND OFF-LABEL USE
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SESSION
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Wednesday, Mar 06
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4:00PM - 5:30PM
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Theme 01 - HTA/Sustainability of Health Systems in Europe
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PAEDIATRIC REQUIREMENTS – DO THEY DELIVER AND AT WHICH COST?
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SESSION
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Wednesday, Mar 06
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4:00PM - 5:30PM
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Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other
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DEVELOPMENT OF PHARMACOVIGILANCE METHODOLOGY
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SESSION
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Wednesday, Mar 06
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4:00PM - 5:30PM
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Theme 04 - Pharmacovigilance
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COLLECTING RELEVANT HEALTH OUTCOME DATA
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SESSION
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Wednesday, Mar 06
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4:00PM - 5:30PM
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Theme 05 - Clinical Research and Development
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HARMONISATION – PITFALLS AND HOW CAN WE SPEED IT UP?
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SESSION
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Wednesday, Mar 06
|
4:00PM - 5:30PM
|
Theme 06 - Quality (including Falsified Medicines)
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WHICH EU REGULATORY RULES FOR TELEMEDICINE, EHEALTH AND MHEALTH? HOW CAN INNOVATION BE ENCOURAGED?
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SESSION
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Wednesday, Mar 06
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4:00PM - 5:30PM
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Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products
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CLINICAL TRIALS IN EUROPE: WILL THE REVISED LEGISLATION MEET THE DEMANDS OF TOMORROW?
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SESSION
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Wednesday, Mar 06
|
4:00PM - 5:30PM
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Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work?
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|
|
STATISTICAL HOT TOPICS IN SCIENTIFIC ADVICE
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SESSION
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Wednesday, Mar 06
|
4:00PM - 5:30PM
|
Theme 15 - Growing Demand for Quantitative Approaches in Drug Development
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OVERVIEW OF CURRENT DISCUSSIONS IN ICH
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SESSION
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Wednesday, Mar 06
|
4:00PM - 5:30PM
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Theme 16 - Non-Clinical
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TOWARDS A EUROPEAN FRAMEWORK FOR CONTINUING PROFESSIONAL DEVELOPMENT IN A LIFE-LONG LEARNING PERSPECTIVE
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SESSION
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Wednesday, Mar 06
|
4:00PM - 5:30PM
|
Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients
|
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