Agendas
9:00 AM — 12:30 PM
EM01: HOT TOPICS IN PHARMACOVIGILANCE AND ADVERSE REACTION REPORTING9:00 AM — 12:30 PM
EM03: ANALYSIS OF SAFETY DATA FROM CLINICAL TRIALS9:00 AM — 12:30 PM
EM04: PRIVACY AND PERSONAL DATA PROTECTION IN DRUG DEVELOPMENT11:00 AM — 12:30 PM
HAS SATELLITE SYPOSIUM9:00 AM — 10:30 AM
EHEALTH: PUTTING INFORMATION TO WORK9:00 AM — 10:30 AM
NEW MEDICAL DEVICE REGULATIONS IN THE EU9:00 AM — 10:30 AM
PHARMACOVIGILANCE DEBATE: BRAVE NEW WORLD OF DECISION SUPPORT9:00 AM — 10:30 AM
THE ROLE OF THE NEW CLINICAL TRIAL LEGISLATION9:00 AM — 10:30 AM
WHAT WILL THE FUTURE BRING – INNOVATIVE PAEDIATRIC DEVELOPMENT11:00 AM — 12:30 PM
ASIA: CREATING POSSIBILITIES FOR CLINICAL DEVELOPMENT AND COLLABORATION11:00 AM — 12:30 PM
HOW WILL THE GLOBAL NEEDS OF PAEDIATRIC DEVELOPMENT BE ADDRESSED?11:00 AM — 12:30 PM
IMPACT OF THE REGULATIONS IN PRACTICE ACROSS REGIONS11:00 AM — 12:30 PM
PHARMACOVIGILANCE: HOW WELL ARE PATIENTS INFORMED AND HOW CAN THEY CONTRIBUTE?11:00 AM — 12:30 PM
QUALITY ASPECTS FOR AN ATMP (M3 OF MAA)11:00 AM — 12:30 PM
REGULATORY EVIDENCE STANDARDS: ARE WE MAXIMISING VALUE GENERATION?11:00 AM — 12:30 PM
THE ROLE OF TRANSLATIONAL MEDICINE IN THE FUTURE OF LIFE SCIENCE11:00 AM — 12:30 PM
VACCINE DEVELOPMENT ACROSS REGIONS2:00 PM — 3:30 PM
ADAPTIVE LICENSING FOR ATMPS2:00 PM — 3:30 PM
CHINESE REGULATORY SESSION: UPDATE FROM THE CFDA2:00 PM — 3:30 PM
CLEARING THE PATH FOR INNOVATIONS IN DRUG DEVELOPMENT2:00 PM — 3:30 PM
GOING MOBILE: DISRUPTIVE TECHNOLOGY AT YOUR FINGERTIPS2:00 PM — 3:30 PM
IS THE CLASSIFICATION OF DISEASE ON PAR WITH THERAPEUTIC INNOVATION?2:00 PM — 3:30 PM
SHAPING EUROPEAN EARLY DIALOGUES: THE SEED PROJECT4:00 PM — 5:30 PM
BENEFIT/RISK- PRAGMATIC LIFECYCLE MANAGEMENT4:00 PM — 5:30 PM
BIG DATA: MOVING BEYOND BUZZ WORDS TO RESULTS4:00 PM — 5:30 PM
CHINA: OPPORTUNITIES AND CHALLENGES FOR INNOVATION4:00 PM — 5:30 PM
IMPACT OF THE REGULATIONS ON SUBSTANCE-BASED MEDICAL DEVICES4:00 PM — 5:30 PM
IN BETWEEN: SMES PERSPECTIVE ON PPPS4:00 PM — 5:30 PM
LIFECYCLE OF REGULATORY/HTA ADVICE4:00 PM — 5:30 PM
LOOKING AT THE FUTURE OF SHORTAGES OF MEDICINAL PRODUCTS4:00 PM — 5:30 PM
NEW AVENUE FOR NON-CLINICAL REGULATORY SCIENCE4:00 PM — 5:30 PM
PRIMARY FACTORS FOR TRIAL LOCATION9:00 AM — 10:30 AM
ATMP REGULATIONS - ONGOING REVIEW9:00 AM — 10:30 AM
DEVELOPING BEST PRACTICE GUIDANCE ON PATIENT ENGAGEMENT IN MEDICINES R&D9:00 AM — 10:30 AM
IS IT OFF-LABEL USE OR MEDICATION ERROR - INTO THE UNKNOWN?9:00 AM — 10:30 AM
NEW IVD REGULATIONS IN THE EU9:00 AM — 10:30 AM
PHARMA MEDICAL AFFAIRS: VISION THROUGH 20209:00 AM — 10:30 AM
THE SILVER GENERATION- HOW DOES DEVELOPMENT ADDRESS THEIR NEEDS?11:00 AM — 12:30 PM
ADJUVANTS IN VACCINES11:00 AM — 12:30 PM
COLLABORATIVE INNOVATION IN BIOMEDICINE SERVING INDUSTRY, ACADEMY AND SOCIETY11:00 AM — 12:30 PM
HOW TO OVERCOME CHALLENGES IN THE DEVELOPMENT OF MEDICINES TO TREAT DEMENTIA11:00 AM — 12:30 PM
MANAGING THE RISK OR MANAGING THE PLAN?11:00 AM — 12:30 PM
SOCIAL MEDIA, PATIENTS AND PUBLIC POLICY2:00 PM — 3:30 PM
BIOVACSAFE (IMI PROJECT)2:00 PM — 3:30 PM
HEALTH APPS: DEFINITION, REGULATION & USE2:00 PM — 3:30 PM
HTA AND ADAPTIVE PATHWAYS2:00 PM — 3:30 PM
MAPPS: FOSTERING COLLABORATIVE MODELS FOR CLINICAL DEVELOPMENT2:00 PM — 3:30 PM
SIGNAL DETECTION AND MANAGEMENT: CAN YOU WHISTLE?2:00 PM — 3:30 PM
WHO OWNS MY HEALTH DATA?4:00 PM — 5:30 PM
50 YEARS AFTER THALIDOMIDE – DEVELOPING DRUGS IN PREGNANCY4:00 PM — 5:30 PM
CHALLENGES FOR DEVELOPMENT OF RARE DISEASES4:00 PM — 5:30 PM
NEW DEVELOPMENTS, EBOLA VACCINES4:00 PM — 5:30 PM
PANEL DISCUSSION WITH PUBLIC-PRIVATE PARTNERSHIP STAKEHOLDERS4:00 PM — 5:30 PM
PRAC: HIGHLIGHTS, CHALLENGES AND REFERRALS4:00 PM — 5:30 PM
REAL WORLD EVIDENCE FOR MEDICINES ADAPTIVE PATHWAYS TO PATIENTS (MAPPS)4:00 PM — 5:30 PM
REGULATORY SCIENCE- NEW PARTNERSHIPS