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Title Event Type Day Time Track(s) Credits
Student Tutorial: THE IMPORTANCE OF EMOTIONAL INTELLIGENCE Session Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
Tutorial 01: INTRODUCTION TO EU PHARMACEUTICAL LAW AND CURRENT DEVELOPMENTS Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 02: IMPLEMENTATION OF THE PHARMACOVIGILANCE LEGISLATION IN THE EU- ACHIEVEMENTS, LESSONS LEARNED AND NEXT STEPS Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 03: PRACTICAL TOOLS FOR SIGNAL MANAGEMENT SYSTEMS: HOW DO YOU OVERCOME CHALLENGES AND MEET THE NEEDS OF NEW PHARMACOVIGILANCE LEGISLATION? IS DATA QUALITY IMPORTANT? Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 04: ANALYSIS OF SAFETY DATA FROM CLINICAL TRIALS Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 05: NON-CLINICAL SAFETY FOR NON-TOXICOLOGISTS: WHAT IS IMPORTANT FOR YOUR SUBMISSIONS? Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 06: BIOSIMILAR DEVELOPMENT- WHAT ARE THE CURRENT CHALLENGES? Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 07: INTRODUCTION TO MEDICAL DEVICES (AND WHAT IS COMING NEXT) Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 08: THE PAEDIATRIC REGULATION STEP BY STEP - FROM THE PIP TO THE REWARD Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 09: EARLY ACCESS SCHEMES: CONSIDERATIONS FOR DEVELOPING REGULATORY STRATEGIES Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 10: HTA: DIFFERENT CONCEPTS FOR DIFFERENT IMPACT ON INNOVATION AND PATIENT ACCESS Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 11: HOW TO REGISTER COMBINATION PRODUCTS AND COMPANION DIAGNOSTICS: REGULATORY FRAMEWORK AND STRATEGIES FOR A SUCCESSFUL DEVELOPMENT Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Tutorial 13: AN INSIDER'S LOOK AT THE EMA: COMMITTEE INTERACTION Tutorial Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time)
Young Professional Tutorial: PLAN YOUR CAREER IN PHARMA OR ASSOCIATED INDUSTRIES Session Tuesday, Mar 25 9:00AM - 12:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
AUSTRIA- AN ATTACTIVE BUSINESS AND RESEARCH LOCATION Session Tuesday, Mar 25 11:00AM - 12:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
Opening Plenary Session Tuesday, Mar 25 2:00PM - 5:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
CREATING AN ADAPTIVE PATHWAY FOR MEDICINES TO PATIENTS - COULD THIS BE AN APPROACH THAT FULFILLS THE NEEDS OF ALL DECISION MAKERS? A ROUNDTABLE DISCUSSION Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
eTRIAL MASTER FILE: CLINICAL IN THE CLOUD(S)? Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 07 - eClinical: Reaching Out
MAKING THE PHARMACOVIGILANCE LEGISLATION WORK – A TEMPERATURE CHECK: PANEL DISCUSSION Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 03 - Benefit/Risk Management and Lifecycle Approach
PAEDIATRIC REWARDS- WHERE DO WE STAND? WHAT ARE THE OBSTACLES, AND HOW COULD THE SYSTEM BE IMPROVED? Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 04 - Special Populations
PATIENTS AS PARTNERS IN CLINICAL RESEARCH Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 09 - Involving and Informing Patients
REGULATORY HARMONISATION AND REGULATORY CONVERGANCE- AN UPDATE Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 10 - Globalisation/Inspections
THE IMPORTANCE FOR ALL TO ADOPT THE NEW PARADIGM IN CLINICAL RESEARCH: INTRODUCTORY SESSION Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 06 - Innovation in Clinical Research
TRANSLATION OF PERSONALISED MEDICINE CONCEPTS Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 05 - Personalised Medicine: Drug-companion diagnostics combinations
TRANSPARENCY – IS CLEARING THE PAST CLOUDING THE FUTURE? Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 13 - The Role of Transparency and Ethics: Legal aspects
WHAT CAN REGULATORY INTELLIGENCE GROUPS LEARN FROM EXPERTS IN KNOWLEDGE MANAGEMENT? Session Wednesday, Mar 26 9:00AM - 10:30AM (Central European Standard Time) Theme 16 - Knowledge Management and Regulatory/Competitive Intelligence
DISCLOSURE OF CLINICAL TRIAL DATA - WHAT DOES THE FUTURE HOLD? Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 13 - The Role of Transparency and Ethics: Legal aspects
eCLINICAL: FASTER, BETTER HIGH-QUALITY TRIAL SET-UP AND CONDUCT Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 07 - eClinical: Reaching Out
FROM BIOMARKERS TO COMPANION DIAGNOSTICS Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 05 - Personalised Medicine: Drug-companion diagnostics combinations
HOW DO PAYERS VIEW CURRENT DEVELOPMENTS IN THE HTA AND REGULATORY ENVIRONMENT? Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
HOW DO PAYERS VIEW CURRENT DEVELOPMENTS IN THE HTA AND REGULATORY ENVIRONMENT? Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
HURDLES TO OVERCOME TO ENSURE REGULATORY SUCCESS FOR THE NEXT GENERATION OF PRODUCTS Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 01 - Regulatory Science
INNOVATION THROUGH PUBLIC PRIVATE PARTNERSHIP COLLABORATIONS Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 14 - Innovation in R&D Models
LATEST DEVELOPMENTS IN PEDIATRICS Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 04 - Special Populations
PATIENT EMPOWERMENT: OPPORTUNITIES AND CHALLENGES Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 09 - Involving and Informing Patients
SURVIVING SAFETY AND QUALITY INSPECTIONS IN THE ERA OF GLOBALISATION: HARMONISING SYSTEMS AND PROCESSES ACROSS COMPANY UNITS Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 10 - Globalisation/Inspections
THE PRACTICAL ASPECTS OF THE REGULATORY INTELLIGENCE FUNCTION – ORGANISATION AND PROCESSES Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 16 - Knowledge Management and Regulatory/Competitive Intelligence
THINKING BEYOND OLD PHARMACOVIGILANCE BOUNDARIES Session Wednesday, Mar 26 11:00AM - 12:30PM (Central European Standard Time) Theme 03 - Benefit/Risk Management and Lifecycle Approach
MEDICINES AND PREGNANCY FORUM: THE PROBLEM, THE STATUS, THE WAY FORWARD Session Wednesday, Mar 26 12:15PM - 1:45PM (Central European Standard Time)
DEVELOPING MEDICINAL PRODUCTS FOR OLDER PEOPLE –GETTING ON TRACK Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 04 - Special Populations
EARLY ACCESS TO UNAUTHORISED MEDICINES Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 13 - The Role of Transparency and Ethics: Legal aspects
eCLINICAL: FROM CASE DECISIONS TO STRATEGIC ALIGNMENT Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 07 - eClinical: Reaching Out
ESTABLISHED INTERACTIONS THROUGHOUT THE REGISTRATION PATHWAY: WHAT EXISTS AND WHAT IS MISSING? Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
GLOBAL DEVELOPMENT AND SUPPLY Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 10 - Globalisation/Inspections
HEALTH ECONOMIC ASPECTS OF PERSONALISED MEDICINE Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 05 - Personalised Medicine: Drug-companion diagnostics combinations
INNOVATION IN BIOMARKERS AND DISEASE STRATIFICATION Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 14 - Innovation in R&D Models
REGULATORY INTELLIGENCE INPUT INTO DEVELOPMENT STRATEGIES Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 16 - Knowledge Management and Regulatory/Competitive Intelligence
REGULATORY TOWN HALL MEETING Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 01 - Regulatory Science
THE NEW PARADIGM IN CLINICAL RESEARCH: THE CASE FOR DEVELOPING NEW ROLES, SKILLS AND COMPETENCIES Session Wednesday, Mar 26 2:00PM - 3:30PM (Central European Standard Time) Theme 06 - Innovation in Clinical Research
CURRENT INDUSTRY PRACTICE FOR BENEFIT/RISK GOVERNANCE Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 03 - Benefit/Risk Management and Lifecycle Approach
DATA INTEGRATION: REACHING THE NEXT LEVEL OF EFFICIENCY Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 07 - eClinical: Reaching Out
DATABASES, REGISTRIES AND OTHER DATA CAPTURE TOOLS: HOW CAN WE AVOID MULTIPLICITY AND CREATE AN INTEGRATED DATA-CAPTURE APPROACH ALONG THE PRODUCT DEVELOPMENT CYCLE? Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
EFFICIENT USE OF SOCIAL MEDIA TO WORK WITH e-PATIENTS Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 09 - Involving and Informing Patients
GCP INSPECTIONS – INTERNATIONAL COLLABORATION AND HARMONISATION EFFORTS Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 10 - Globalisation/Inspections
HOW TO GET READY FOR THE NEW CLINICAL TRIALS LEGISLATION Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 01 - Regulatory Science
INNOVATION IN CLINICAL TRIAL DESIGN AND EVALUATION Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 14 - Innovation in R&D Models
OPTIMISING CLINICAL RESEARCH: WHICH INFRACTURIAL AND BUSINESS RELATIONSHIP CHANGES DO WE NEED TO CONSIDER? Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 06 - Innovation in Clinical Research
REGULATORY INTELLIGENCE IN PRACTICE – HOW REGULATORY AUTHORITIES INFORM ABOUT DECISION MAKING Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 16 - Knowledge Management and Regulatory/Competitive Intelligence
THE CASE FOR AND AGAINST A REFORM OF THE PHARMACEUTICAL LEGISLATION Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
THE SOCIETAL PERSPECTIVE ON PERSONALISED MEDICINE - MANAGING THE PARADIGM SHIFT Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 05 - Personalised Medicine: Drug-companion diagnostics combinations
UNINTENDED IMPLICATIONS OF TRANSPARENCY: PATENTABILITY, USE OF COMPETITORS BY EX-EU AND MEDICAL JOURNALS Session Wednesday, Mar 26 4:00PM - 5:30PM (Central European Standard Time) Theme 13 - The Role of Transparency and Ethics: Legal aspects
BIOSIMILARS- BUILDING ON EUROPEAN FOUNDATIONS TO ACHIEVE GLOBAL HARMONISATION Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 01 - Regulatory Science
EUROPEAN COMMISSION’S eHEALTH ACTION PLAN 2012-2020 Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 08 - eHealth: Innovation in Healthcare and its Impact on Industry
GLOBAL SUBMISSION AND REVIEW STRATEGY - HOW RAPIDLY INNOVATION CAN REACH GLOBAL MARKETS Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 10 - Globalisation/Inspections
INNOVATION IN DRUG DELIVERY SYSTEMS AND COMPLIANCE Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 14 - Innovation in R&D Models
INNOVATIVE METHODOLOGIES USED IN ENHANCING QUALITY Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 06 - Innovation in Clinical Research
MARKETING AUTHORISATION AND BEYOND: MOVING FROM EARLY DIALOGUE TO CONTINUOUS DIALOGUE – CREATING AN INTEGRATED RESEARCH AND DEVELOPMENT PATHWAY: PROVIDING A ‘ONE-STOP SHOP’ FOR INDUSTRY? Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
NEW ACTIVE SUBSTANCES AND KNOWN ACTIVE SUBSTANCES – DESIGNATION, IMPLICATIONS Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 15 - New and Known Substances - how to fit the rules to needs
PANEL DISCUSSION: TRANSPARENCY IN THE PHARMACEUTICAL SECTOR – WHAT HAVE WE LEARNED? Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 03 - Benefit/Risk Management and Lifecycle Approach
QUALITY BY DESIGN (QBD) AND INNOVATION IN DEVELOPMENT AND MANUFACTURING Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 12 - Pharmaceutical Quality in the 21st Century
THE CHANGING FACE OF THE EMA – INSIDE AND OUT: AN OVERVIEW OF THE NEW STRUCTURE AND EXPECTATIONS FROM THE CHANGES Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
TRANSPARENCY OF PAYMENTS TO THE HEALTHCARE SECTOR Session Thursday, Mar 27 9:00AM - 10:30AM (Central European Standard Time) Theme 13 - The Role of Transparency and Ethics: Legal aspects
CHALLENGES AND OPPORTUNITIES IN THE IMPLEMENTATION OF THE FALSIFIED MEDICINES DIRECTIVE Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 01 - Regulatory Science
DISCLOSURE OF SAFETY DATA: CAN PRAC, PATIENTS AND INDUSTRY PERSPECTIVES BE RECONCILED? Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 13 - The Role of Transparency and Ethics: Legal aspects
EXPERIENCE WITH IMPLEMENTATION OF THE LIFECYCLE APPROACH Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 12 - Pharmaceutical Quality in the 21st Century
HOW TO REALISE BIOSIMILARS’ FULL POTENTIAL Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 15 - New and Known Substances - how to fit the rules to needs
INNOVATION IN PRECLINICAL AND CLINICAL SAFETY SCIENCES Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 14 - Innovation in R&D Models
INTEROPERABILITY FOR HEALTHCARE PROVIDERS ACROSS THE EU Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 08 - eHealth: Innovation in Healthcare and its Impact on Industry
MOVING FROM RISK MANAGEMENT TO BENEFIT/RISK MANAGEMENT PLANNING Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 03 - Benefit/Risk Management and Lifecycle Approach
PANEL DISCUSSION: REGULATION 2025 – STAKEHOLDER VISION FOR THE FUTURE OF THE GLOBAL REGULATORY FRAMEWORK BETWEEN NOW AND 2025 Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 10 - Globalisation/Inspections
PMDA UPDATE Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
THE NEW PARADIGM IN CLINICAL RESEARCH: STAKEHOLDER PERSPECTIVES FOR A RATIONAL PROCESS Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 06 - Innovation in Clinical Research
THE NEW REGULATORY OUTLOOK FOR DEVICES, IVDS AND COMBINATION PRODUCTS Session Thursday, Mar 27 11:00AM - 12:30PM (Central European Standard Time) Theme 11 - Regulation of Medical Devices and Combination Products
Briefing on Advanced Therapy Medicinal Products: THE HOSPITAL EXEMPTION FOR ADVANCED THERAPIES: CAN WE BRIDGE THE GAP BETWEEN LOCAL TREATMENTS AND PAN-EUROPEAN STANDARDISED THERAPIES? Session Thursday, Mar 27 12:45PM - 1:45PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
BIG DATA, eHEALTH RECORDS AND TAXONOMY Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 08 - eHealth: Innovation in Healthcare and its Impact on Industry
CURRENT STATUS AND FUTURE CHALLENGES OF ASIAN REGULATORY ENVIRONMENT Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 10 - Globalisation/Inspections
GCP HOT TOPIC 1 - THE USE OF ELECTRONIC HEALTH RECORDS BY INVESTIGATORS AND SPONSORS FOR CLINICAL RESEARCH Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
HOW DO WE BRING THE PATIENT’S VOICE INTO THE DISCUSSION? HOW DO WE ENSURE THAT ALL THE RIGHT VOICES ARE HEARD? Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
HOW TO OVERCOME THE OBSTACLES IN PATIENTS’ ACCESS Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 15 - New and Known Substances - how to fit the rules to needs
KEY CONSIDERATIONS FOR DEVELOPMENT AND APPROVAL OF COMPANION DIAGNOSTICS Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 11 - Regulation of Medical Devices and Combination Products
NON-CLINICAL DEVELOPMENT STRATEGIES FOR BIOSIMILAR MONOCLONAL ANTIBODIES Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 14 - Innovation in R&D Models
OPTIMISING REGULATORY OPERATIONS THROUGH USE OF INFORMATION TECHNOLOGY Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 01 - Regulatory Science
PERIODIC BENEFIT RISK EVALUATION REPORTING – HAS IT ACHIEVED WHAT IT SET OUT TO DO? Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 03 - Benefit/Risk Management and Lifecycle Approach
PRODUCT LIABILITY, OFF-LABEL USE AND PATIENT INFORMATION LEAFLETS Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 13 - The Role of Transparency and Ethics: Legal aspects
SYSTEMATIC APPROACHES TO DELIVER QUALITY: LEARN FROM THE EXPERTS! Session Thursday, Mar 27 2:00PM - 3:30PM (Central European Standard Time) Theme 06 - Innovation in Clinical Research
ARE OUR HEALTHCARE SYSTEMS READY TO SUPPORT THESE APPROACHES? WHAT – IF ANYTHING – NEEDS TO CHANGE? A ROUNDTABLE DISCUSSION Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 02 - HTA/Regulatory Interface
CHALLENGES AND OPPORTUNITIES FOR PHARMACEUTICAL QUALITY Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 12 - Pharmaceutical Quality in the 21st Century
CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES AND COMBINATION PRODUCTS Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 11 - Regulation of Medical Devices and Combination Products
GCP HOT TOPIC 2- GCP SENIOR EXPERTS’ ROUNDTABLE Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 17 - Hot Topics/Stand Alone
PHARMA INDUSTRY INCENTIVE SYSTEMS Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 14 - Innovation in R&D Models
REGULATORY SIMPLIFICATION: VISION, OXYMORON, OR ‘MISSION IMPOSSIBLE’? Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 10 - Globalisation/Inspections
RISK MINIMISATION AND ITS EFFECTIVENESS – WHAT IS STATE OF THE ART AND WHAT IS REALISTIC? Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 03 - Benefit/Risk Management and Lifecycle Approach
RISK PERCEPTION, RISK ACCEPTANCE AND KNOWN ACTIVE SUBSTANCES Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 15 - New and Known Substances - how to fit the rules to needs
THE BRAVE NEW WORLD OF DIGITAL DATA: WHAT ARE THE NEW LEGAL AND ETHICAL QUESTIONS? Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 06 - Innovation in Clinical Research
THE ROLE OF SOCIAL MEDIA IN HEALTHCARE Session Thursday, Mar 27 4:00PM - 5:30PM (Central European Standard Time) Theme 08 - eHealth: Innovation in Healthcare and its Impact on Industry