Agenda
9:00 AM — 10:30 AM
MAKING THE MOST OUT OF THE DIA EUROMEETING IN ORDER TO ENTER THE INDUSTRY9:00 AM — 12:30 PM
Roundtable 01: GCP Inspections and Audit Findings9:00 AM — 12:30 PM
Tutorial 02: Analysis of Safety Data from Clinical Trials9:00 AM — 12:30 PM
Tutorial 03: Update on Practical Work with Variation Regulation9:00 AM — 12:30 PM
Tutorial 04: Introduction to Medical Device Regulation9:00 AM — 12:30 PM
Tutorial 05: Recent and Current developments in Pharmaceutical Law9:00 AM — 12:30 PM
Tutorial 08: Health Technology Assessment of Drugs and Medical Devices9:00 AM — 12:30 PM
Tutorial 13: Technology Transfer for Biopharmaceuticals Workshop9:00 AM — 12:30 PM
Tutorial 14: Pharmacovigilance Audits and Inspections9:00 AM — 12:30 PM
Tutorial 15: Coding with Confidence9:00 AM — 12:30 PM
Tutorial 17: Creating Compliant Clinical Study Reports for the EU and US11:00 AM — 12:30 PM
ENHANCING YOUR SOFT SKILLS BY IMPROVING YOUR EMOTIONAL INTELLIGENCE (EQ)11:00 AM — 12:30 PM
YOUNG PROFESSIONALS IN THE PHARMACEUTICAL INDUSTRY9:00 AM — 10:30 AM
BOTTLENECKS IN RESEARCH: HOW DO WE REPLENISH THE PIPELINE?9:00 AM — 10:30 AM
DRUG SHORTAGE MANAGEMENT- ENSURING MEDICINE SUPPLY9:00 AM — 10:30 AM
IMPLEMENTATION OF THE NEW PHARMACOVIGILANCE LEGISLATION9:00 AM — 10:30 AM
LEARNED SOCIETIES AND DRUG REGULATION9:00 AM — 10:30 AM
MECHANISM OF ACTION - THE LEADING PARADIGM9:00 AM — 10:30 AM
MIGRATION FROM PAPER TO ELECTRONIC9:00 AM — 10:30 AM
NEW APPROACHES FOR MONITORING9:00 AM — 10:30 AM
NEW RULES FOR ASSESSMENT OF KNOWN ACTIVE SUBSTANCES9:00 AM — 10:30 AM
REGULATORY DATA PROTECTION9:00 AM — 10:30 AM
SAFE, EFFECTIVE AND AFFORDABLE MEDICINAL PRODUCTS FOR A GLOBAL POPULATION9:00 AM — 10:30 AM
SETTING THE SCENE: IMPORTANCE OF REGULATORY SCIENCE THROUGHOUT11:00 AM — 12:30 PM
BENEFIT/RISK MANAGEMENT IN PHARMACOVIGILANCE11:00 AM — 12:30 PM
BEST PRACTICES IN PHARMACOVIGILANCE GOVERNANCE11:00 AM — 12:30 PM
CLINICAL STANDARDS AND METADATA11:00 AM — 12:30 PM
COHORT STUDIES OF THE ELDERLY AS A TOOL FOR DRUG DEVELOPMENT AND TESTING11:00 AM — 12:30 PM
DEVELOPMENT AND REGULATORY FRAMEWORK FOR COMPANION DIAGNOSTICS11:00 AM — 12:30 PM
HARMONISATION: CHALLENGES IN PRODUCT INFORMATION / LABELLING11:00 AM — 12:30 PM
INCENTIVES FOR PAEDIATRIC CLINICAL RESEARCH11:00 AM — 12:30 PM
INTERNATIONAL COLLABORATION IN THE REVIEW OF GENERIC DRUGS11:00 AM — 12:30 PM
PATIENTS AS EXPERTS IN DRUG REGULATION11:00 AM — 12:30 PM
THE EU QUALIFIED PERSON IN A GLOBAL ENVIRONMENT11:00 AM — 12:30 PM
THE EUROPEAN LANDSCAPE ON HTA - THE EUnetHTA JOINT ACTION11:00 AM — 12:30 PM
THE WAY FORWARD IN CNS: REGULATORY SCIENCE AT THE EDGE11:00 AM — 12:30 PM
WHY TRIALS FAIL AND HOW TO PREVENT THIS2:00 PM — 3:30 PM
COMPARATIVE EFFECTIVENESS AS PART OF THE PUBLIC ASSESSMENT REPORT (PAR)2:00 PM — 3:30 PM
ELECTRONIC HEALTH RECORDS2:00 PM — 3:30 PM
ENHANCING CLINICAL RESEARCH EFFECTIVENESS2:00 PM — 3:30 PM
FALSIFIED MEDICINES DIRECTIVE AND ACTIVE SUBSTANCES2:00 PM — 3:30 PM
FIRST EXPERIENCE WITH THE PHARMACOVIGILANCE LEGISLATION2:00 PM — 3:30 PM
PHARMACOVIGILANCE AND MEDICINAL PRODUCT STANDARDS AND METADATA2:00 PM — 3:30 PM
PRESERVING WHAT WE HAVE - PRUDENT AND CONTROLLED USE2:00 PM — 3:30 PM
SFDA SESSION - GMP IN CHINA2:00 PM — 3:30 PM
THE ESCHER PROJECT: REGULATORY SCIENCE IN PRACTICE4:00 PM — 5:30 PM
ADAPTIVE CLINICAL TRIAL DESIGNS4:00 PM — 5:30 PM
BIOSIMILARS4:00 PM — 5:30 PM
EARLY DIALOGUE IN DRUG DEVELOPMENT4:00 PM — 5:30 PM
FALSIFIED MEDICINES DIRECTIVE AND SERIALISATION4:00 PM — 5:30 PM
GCP HOT TOPICS: THE CHALLENGES IN THE CRO-SPONSOR RELATIONSHIP4:00 PM — 5:30 PM
HANDLING CONFLICT OF INTEREST (COI)4:00 PM — 5:30 PM
MESSAGES FROM THE AGENCIES4:00 PM — 5:30 PM
NEW APPROACHES TO COMBAT RESISTANCE4:00 PM — 5:30 PM
PATIENT AND CONSUMER ROLES: THEIR INPUT IN REGULATORY SCIENCE4:00 PM — 5:30 PM
XEVMPD: LONG-TERM EXPECTATIONS AND BENEFITS6:00 PM — 7:30 PM
PHARMACEUTICAL LAW IN THE NETHERLANDS: BUILDING AN EU ASSOCIATION?9:00 AM — 10:30 AM
EMA ROUNDTABLE- SCIENTIFIC COMMITTEES UNITED IN DIVERSITY9:00 AM — 10:30 AM
FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)9:00 AM — 10:30 AM
FOCUS ON MEDICINES EFFICACY, SAFETY AND USAGE IN EDUCATION AND TRAINING9:00 AM — 10:30 AM
FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALS9:00 AM — 10:30 AM
HOW TO OPTIMISE CLINICAL DEVELOPMENT IN THE ELDERLY: SOME PRACTICAL EXAMPLES9:00 AM — 10:30 AM
INNOVATIVE APPROACHES TO PRODUCT INFORMATION FOR PHYSICIANS AND PATIENTS9:00 AM — 10:30 AM
KNOWN ACTIVE SUBSTANCES FOR THE SELF-CARE SECTOR9:00 AM — 10:30 AM
MNC’S EXPANSION IN EMERGING MARKETS: OPPORTUNITIES AND CHALLENGES9:00 AM — 10:30 AM
NEW OPPORTUNITIES FOR INFORMATION TECHNOLOGY IN PHARMACOVIGILANCE9:00 AM — 10:30 AM
NON-CLINICAL TESTING FOR ADVANCED THERAPY9:00 AM — 10:30 AM
QUALITY UPDATE - CURRENT DEVELOPMENTS9:00 AM — 10:30 AM
SOCIAL MEDIA/USE OF TABLETS AND SMARTPHONES11:00 AM — 12:30 PM
ADOPTION OF GAME CHANGING TECHNOLOGIES11:00 AM — 12:30 PM
ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTS11:00 AM — 12:30 PM
ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS11:00 AM — 12:30 PM
EQUIVALENCE OF ORALLY INHALED PRODUCTS11:00 AM — 12:30 PM
JAPANESE REGULATORY SESSION – PMDA UPDATE11:00 AM — 12:30 PM
NEW TRENDS IN INVITRO NON-CLINICAL TESTING11:00 AM — 12:30 PM
PAEDIATRIC CLINICAL TRIALS – TRIAL BY DESIGN11:00 AM — 12:30 PM
QUALITY CAREER DEVELOPMENT IN GLOBAL MEDICINES DEVELOPMENT11:00 AM — 12:30 PM
QUALITY RISK MANAGEMENT WORKSHOP11:00 AM — 12:30 PM
RISK COMMUNICATION AND TRANSPARENCY11:00 AM — 12:30 PM
THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS11:00 AM — 12:30 PM
TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED?2:00 PM — 3:30 PM
ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN2:00 PM — 3:30 PM
COMBINATION MEDICINAL DRUG PRODUCTS OF KNOWN ACTIVE SUBSTANCES2:00 PM — 3:30 PM
IMPACT OF ICH E2C (R2) AND GVP MODULE VII2:00 PM — 3:30 PM
LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE2:00 PM — 3:30 PM
NEW ICH INITIATIVES IN SAFETY TESTING2:00 PM — 3:30 PM
PATIENT RECRUITMENT AND RETENTION2:00 PM — 3:30 PM
PERSPECTIVES AND COLLABORATION BETWEEN PATIENTS AND STUDENTS2:00 PM — 3:30 PM
PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY2:00 PM — 3:30 PM
REGULATORY TOWN HALL MEETING2:00 PM — 3:30 PM
SUBGROUP ANALYSES2:00 PM — 3:30 PM
THE PATIENTS’ PERSPECTIVE ON HTA4:00 PM — 5:30 PM
COLLECTING RELEVANT HEALTH OUTCOME DATA4:00 PM — 5:30 PM
DEVELOPMENT OF PHARMACOVIGILANCE METHODOLOGY4:00 PM — 5:30 PM
HARMONISATION – PITFALLS AND HOW CAN WE SPEED IT UP?4:00 PM — 5:30 PM
HTA AND OFF-LABEL USE4:00 PM — 5:30 PM
OVERVIEW OF CURRENT DISCUSSIONS IN ICH4:00 PM — 5:30 PM
PAEDIATRIC REQUIREMENTS – DO THEY DELIVER AND AT WHICH COST?4:00 PM — 5:30 PM
STATISTICAL HOT TOPICS IN SCIENTIFIC ADVICEHave an account?