アジェンダ
9:00 AM — 12:30 PM
9:00 AM — 12:30 PM
TUT04: Analysis of Safety Data from Clinical Trials9:00 AM — 12:30 PM
TUT06: Hot Topic in Pharmacovigilance and Adverse Reaction Reporting1:30 PM — 3:00 PM
European Regulatory Town Hall Meeting4:00 PM — 5:45 PM
Opening Plenary: INnovation - Do You Win by Being IN?9:00 AM — 10:30 AM
Benefit-Risk Management Planning through the Life Cycle of a Product9:00 AM — 10:30 AM
Innovation for Patient Reporting9:00 AM — 10:30 AM
New Medical Device Regulations in the EU9:00 AM — 10:30 AM
Patient-Focused Medicine – To Understand Patients You Must Engage Them9:00 AM — 10:30 AM
Translation of Cell and Gene Therapies9:00 AM — 10:30 AM
What Happens in and Around Europe – Beyond the European Union?9:00 AM — 10:30 AM
Women’s Health and Drug Development11:00 AM — 12:30 PM
ICH E6- GCP Addendum: Risk Proportionate Approaches to Trial Design and Conduct11:00 AM — 12:30 PM
Perspectives on Medication Errors11:00 AM — 12:30 PM
Physician Engagement, Education and Communication in an Era of Transparency11:00 AM — 12:30 PM
Strengthening of Regulatory Systems: How is it Achieved and When?11:00 AM — 12:30 PM
The Needs of the Payers Shape the Evidence for Market Access2:00 PM — 3:30 PM
Assessing the Benefits and Risks as the Basis of Benefit-Risk Management2:00 PM — 3:30 PM
Clinical Trial Disclosure2:00 PM — 3:30 PM
Digital Health: How Digital Technology is Transforming Health Care2:00 PM — 3:30 PM
End-to-End Pharmacovigilance Quality and Compliance2:00 PM — 3:30 PM
Innovative Developments in Medical Technology2:00 PM — 3:30 PM
Real-World Data Making Personalised Medicine a Reality2:00 PM — 3:30 PM
Securing the Supply Chain: How to Tackle the Challenges2:00 PM — 3:30 PM
The Voice of the Patient – Innovative Ways of Patient Engagement in R&D4:00 PM — 5:30 PM
Adaptive Pathways and Conditional Approval – Panel Discussion4:00 PM — 5:30 PM
Combination Products4:00 PM — 5:30 PM
Japanese Regulatory Session: PMDA Update9:00 AM — 10:30 AM
Content and Context of IDMP9:00 AM — 10:30 AM
Formulations for Both Ends of Life9:00 AM — 10:30 AM
Improving Global Health: How Can Regulators Help?9:00 AM — 10:30 AM
Improving Productivity in R&D9:00 AM — 10:30 AM
It´s Never Too Soon – Early Access and Early Dialogue in Drug Development9:00 AM — 10:30 AM
Post-Marketing Surveillance and CE Marketing9:00 AM — 10:30 AM
Setting the Scene – Is There an Availability Problem in Europe?11:00 AM — 12:30 PM
Cutting Blockbuster Indications into Orphan-Sized Bites11:00 AM — 12:30 PM
Evolving Areas of Regulatory Science11:00 AM — 12:30 PM
From Tradition to Regulation – Globalisation of Herbal Medicines11:00 AM — 12:30 PM
MAPPs: The IMI ADAPT SMART Project11:00 AM — 12:30 PM
Medicinal Products in Need11:00 AM — 12:30 PM
Planning and Oversight for Success11:00 AM — 12:30 PM
Self-Care Medical Devices: Shifting Borders between Devices and Pharma?2:00 PM — 3:30 PM
Development of New Medicines – Engaging with Stakeholders2:00 PM — 3:30 PM
Effective and Balanced Risk Communication2:00 PM — 3:30 PM
HTA for Medical Devices2:00 PM — 3:30 PM
Innovation in the Development and Approval of Generic Medicines2:00 PM — 3:30 PM
Innovation of Mature Products – New Uses for Old Products2:00 PM — 3:30 PM
MAPPs: The IMI ADAPT SMART Project2:00 PM — 3:30 PM
No Marketing of Authorised Products2:00 PM — 3:30 PM
Shaking the Toolbox: Evolutions in Approaches in Trial Design2:00 PM — 3:30 PM
The Growing Role and Importance of Interoperability and Standardisation4:00 PM — 5:30 PM
Challenges for Academic Clinical Trials4:00 PM — 5:30 PM
European Relative Effectiveness Assessments4:00 PM — 5:30 PM
Examples of Big Data Applications4:00 PM — 5:30 PM
Impact of Regulatory Measures to Optimise Benefit/Risk Decisions4:00 PM — 5:30 PM
IVDs and Companion Diagnostics4:00 PM — 5:30 PM
Shortages of Authorised Products4:00 PM — 5:30 PM
Where is the Orphan Drug Journey Going?