アジェンダ
2:00 PM — 5:30 PM
Guidance for Patient Involvement in Pharmaceutical Industry-Led Research2:00 PM — 5:30 PM
Guidance for Patient Involvement in Pharmaceutical Industry-Led Research2:00 PM — 5:30 PM
Hot Topics in Pharmacovigilance2:00 PM — 5:30 PM
Hot Topics in Pharmacovigilance2:00 PM — 5:30 PM
Workshop: Revision of the EU Clinical Trial Risk Mitigation Guideline2:00 PM — 5:30 PM
Workshop: Revision of the EU Clinical Trial Risk Mitigation Guideline3:00 PM — 5:00 PM
Visits at Industry Sites6:00 PM — 7:30 PM
Making the Most of Mentoring - Women in Healthcare Business6:00 PM — 7:30 PM
Regulatory Affairs: One Area, Many Careers!6:00 PM — 7:30 PM
Value and Access7:30 PM — 9:00 PM
9:00 AM — 12:30 PM
Genomics in Clinical Development9:00 AM — 12:30 PM
Genomics in Clinical Development9:00 AM — 10:30 AM
Leader of Tomorrow: Veni.Vidi.Dici11:00 AM — 12:30 PM
International Pharmacovigilance11:00 AM — 12:30 PM
Leader of Tomorrow: Creating Relevant Opportunities11:00 AM — 12:30 PM
Payer Town Hall Meeting: WHO Fair Pricing1:00 PM — 1:45 PM
CAT Spotlight: What’s on the Horizon for ATMPS in the Near Future?1:00 PM — 3:30 PM
DIAlogue: The New EMA First-in-Human (FIH) Guideline1:00 PM — 1:45 PM
EFPIA Spotlight: Pharmaceuticals in the Environment2:00 PM — 3:30 PM
Will Big Data Change Drug Development’s Approach?4:00 PM — 6:00 PM
Keynote Session: A Digital Revolution at the Crossroads of Healthcare8:30 AM — 10:00 AM
Patient Centricity beyond the Talk10:30 AM — 12:00 PM
EMA Proactive Transparency – Clinical Data Publication (Policy 0070)10:30 AM — 11:00 AM
Endpoints in Clinical Research10:30 AM — 12:00 PM
Enhancing Benefit-Risk Management through the Product Life Cycle10:30 AM — 12:00 PM
Fighting the Fakes – Preparing for Upcoming EU Medicine Serialisation10:30 AM — 12:00 PM
Has the Time for Big/Real World Data Finally Arrived?10:30 AM — 12:00 PM
IVD Regulation and the Upcoming Changes in Regulatory Landscape10:30 AM — 12:00 PM
Novel Therapeutic Approaches10:30 AM — 12:00 PM
Update on PMDA’s Activities12:30 PM — 1:30 PM
ADAPT SMART Spotlight2:00 PM — 3:15 PM
Data Sharing and Secondary Use of Data2:00 PM — 3:15 PM
Digital Health : What is the Landscape Looking like for Medicines?2:00 PM — 3:15 PM
Innovative Approaches to Safety Information2:00 PM — 3:15 PM
New Collaboration Models with Regulators and Patients2:00 PM — 3:15 PM
Patient Centricity – What does it Really Mean?2:00 PM — 3:15 PM
Registry Studies: What Are the Expectations from the Regulators?2:00 PM — 3:15 PM
Regulatory Access Pathways to Facilitate Early Access and HTA Synergies4:00 PM — 5:30 PM
Drawing the Boundaries of Data Disclosure in Clinical Trials4:00 PM — 4:30 PM
Drivers, Barriers, and Benefits of a Unified Clinical Operating Model4:00 PM — 5:30 PM
Enhancing Evidence Generation across the Product Life Cycle4:00 PM — 5:30 PM
Health Economics of Future Therapeutic Concepts4:00 PM — 5:30 PM
Measuring Impact of Pharmacovigilance in the EU4:00 PM — 5:30 PM
Needed Competencies for Big Data – Learning from Other Industries4:00 PM — 5:30 PM
Russia and the Eurasian Union – Regulatory Challenges and Opportunities4:45 PM — 5:15 PM
The Master’s Data Management from the ‘Single Place of Truth’8:30 AM — 10:00 AM
ATMPs8:30 AM — 10:00 AM
DIAlogue: The Role of Unmet Need in Regulatory and Pricing Decision Making8:30 AM — 10:00 AM
GMP Convergence – A Key Part of Regulatory System Strengthening8:30 AM — 10:00 AM
ICH Info Day Part 18:30 AM — 10:00 AM
Life Cycle Management Activities of Drug Device Combinations8:30 AM — 10:00 AM
Overview of Major Big Data Projects across EU, US, Japan8:30 AM — 10:00 AM
Smarter Clinical Trials with Real World Evidence Data8:30 AM — 10:00 AM
Value and Access – How Do We Strike a Balance between Both?10:30 AM — 12:00 PM
Big Data Mandates Strict Data Governance10:30 AM — 12:00 PM
ICH Info Day Part 210:30 AM — 12:00 PM
Impact of Human Factors on the Development of Combination Products10:30 AM — 12:00 PM
Life Cycle Management – The Unknown Barrier to Access10:30 AM — 12:00 PM
Precision Medicine and Personalised Healthcare10:30 AM — 12:00 PM
The Promise and Reality of Clinical Trial Transparency Initiatives10:30 AM — 12:00 PM
Turkish Regulatory Session1:00 PM — 2:00 PM
Conference Insights and Outcomes – Rapid Fire Session