Agenda
2:00 PM — 5:30 PM
Short Course 1: Benefit-Risk Management Methodologies11:00 AM — 12:30 PM
European Regulatory Town Hall Meeting – Key Topics for the Future11:00 AM — 12:30 PM
Real World Data: How to Deliver its Potential to Support Innovation2:00 PM — 3:15 PM
Patient Engagement as a Strategic Imperative in Therapeutic Innovation3:30 PM — 4:00 PM
Accelerating Clinical Study Start Up with Innovative Technologies3:30 PM — 4:00 PM
Oral Poster Session 3 - Patient Engagement & Medical Affairs Content Hub4:00 PM — 5:30 PM
Pharmacovigilance and Post Market Surveillance4:00 PM — 5:30 PM
The Convergence of Medicines, Medical Devices and Analytics4:00 PM — 5:30 PM
Women in Leadership Forum8:30 AM — 9:00 AM
Will Virtual Patients Allow for Virtual Trials?9:15 AM — 10:15 AM
Brexit and the European Network: 1,5 months to go! Where Do We Stand?9:15 AM — 10:15 AM
EU Cooperation on HTA and beyond - Current Action and Future Developments10:15 AM — 10:45 AM
Oral Poster Session 4 - Regulatory Science & Value and Access Content Hub10:45 AM — 11:45 AM
Clinical Trials and GDPR10:45 AM — 11:45 AM
Digital Disruptors: What Do We Mean?10:45 AM — 11:45 AM
How Will New Tech, RWD & AI Change Regulatory Systems and Processes?10:45 AM — 11:45 AM
Impact of Pharmacovigilance on Public Health10:45 AM — 11:45 AM
Optimising Orphan Drug Development in the EU10:45 AM — 11:45 AM
Re-Thinking Clinical Development10:45 AM — 11:45 AM
The Added Value of Medical Functions: Building a Long-Term Strategy10:45 AM — 11:45 AM
The Impact of Innovation and Novel Pathways: The Role of the Regulator11:15 AM — 11:45 AM
AI on the Rise - digitally transforming pharma’s regulatory processes11:15 AM — 11:45 AM
The Language of Patients Meets the Language of Safety Science12:00 PM — 1:15 PM
Blockchain in Healthcare and Pharma12:00 PM — 12:30 PM
Bridging the Gap between Managed Healthcare and Clinical Research12:00 PM — 1:15 PM
Creating Value for Patients12:00 PM — 1:15 PM
Driving for Regulatory Excellence in Turkey12:00 PM — 12:30 PM
EUPATI Update12:00 PM — 1:15 PM
Forum on Global Pharmacovigilance12:00 PM — 1:15 PM
How Can the EU Regulatory Network Support Innovation?12:00 PM — 1:15 PM
How is R&D Being Reflected in Academia vs Industry12:00 PM — 1:15 PM
Optimising Paediatric Drug Development in the EU12:00 PM — 1:15 PM
Where Will Patients Come from in the Future? EHR and Biobanks12:30 PM — 1:00 PM
Unmet Medical Need Papers2:15 PM — 3:15 PM
3:15 PM — 4:15 PM
Change is Coming… Getting the Questions Right in Clinical Development3:15 PM — 4:15 PM
Histology-Independent Indications3:15 PM — 4:15 PM
Medical Functions Contribution to Benefit-Risk Assessment3:15 PM — 4:15 PM
The New EudraVigilance System: One Year After3:15 PM — 4:15 PM
The Regulatory Role in EU Public-Private Partnerships (PPPs)3:15 PM — 4:15 PM
Value and Access4:45 PM — 6:00 PM
Dialog with Patients - Moving Forward with Digital Information4:45 PM — 6:00 PM
Evidence Generation as a Continuum: Can We Benefit from Advice?4:45 PM — 6:00 PM
Outcomes Measurement: The Key to Value-Based Healthcare4:45 PM — 6:00 PM
Patient Preferences – The Science of Tomorrow4:45 PM — 6:00 PM
Regulatory Affairs: Career Opportunities and Field Development4:45 PM — 5:15 PM
Repurposing - Working Together on New Uses for Old Drugs4:45 PM — 6:00 PM
Study Design and Innovative Statistics4:45 PM — 6:00 PM
4:45 PM — 6:00 PM
Update on PMDA’s Activities5:15 PM — 5:45 PM
New Changes to the National Drug Code in the U.S.8:30 AM — 9:00 AM
Health Systems: Doomed to Fail or About Be Saved by a Copernican Shift?9:15 AM — 10:15 AM
Automatic Translations Workshop9:15 AM — 10:15 AM
China - Update on the Regulatory Environment9:15 AM — 10:15 AM
Converging Global Life Science Regulation – Where Are We Heading in 2025?9:15 AM — 9:45 AM
Data’s Revenge9:15 AM — 10:15 AM
How to Extend MSL Expertise to Patient Engagement Activities9:15 AM — 10:15 AM
How to Facilitate Access to Advanced Therapy Medicinal Products in Europe9:15 AM — 9:45 AM
Innovation in Pharmacovigilance9:15 AM — 10:15 AM
Orphan and Paediatric Medicines – Future Direction and Regulatory Landscape9:15 AM — 10:15 AM
Reducing Cost and Improving Quality of Clinical Trials9:45 AM — 10:15 AM
Innovative Designs under the New Clinical Trials Regulations10:45 AM — 11:45 AM
Can We Improve Patient Experience with Digitisation – Part 2: Digital Devices10:45 AM — 11:45 AM
ICH Info Day – Part 110:45 AM — 11:45 AM
Regulatory Data Use and Integrity across Stakeholders10:45 AM — 11:45 AM
Regulatory Innovation: Regulatory Science10:45 AM — 11:45 AM
Risk Communication: New Directions for the Future10:45 AM — 11:45 AM
10:45 AM — 11:45 AM
The Eurasian Union - Reflection on the Changes in Regulatory and Ways of Working10:45 AM — 11:45 AM
Will Patient Involvement Improve Clinical Research?12:00 PM — 1:15 PM
Capacity Building and Capability Building in Pharmacovigilance12:00 PM — 1:15 PM
Converging Global Life Science Regulation – Where Are We Heading in 2025?12:00 PM — 1:15 PM
Hey Siri, I Am Not Feeling Well Today12:00 PM — 1:15 PM
ICH Info Day – Part 212:00 PM — 1:15 PM
Preparing the Way for a Learning Healthcare Ecosystem12:00 PM — 1:15 PM
Strengthening the Supply Chain to Improve Access to Medicines in Africa2:00 PM — 3:00 PM
Modern Clinical Research and Paradigm Shift – What Can We Take Home?2:00 PM — 3:00 PM
Raising Europe’s Voice in Globalising Regulatory Science3:15 PM — 4:15 PM
Conference Insights and Outcomes – Rapid Fire SessionHave an account?