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Wednesday, February 6
 

08:30

#KN2: Will Virtual Patients Allow for Virtual Trials? E1

09:15

#DMD7: Digital Trials, Sensors, Bots, AI/Machine Learning, RWD– Will Product Approvals Be Accelerated By These New Technologies? E1 #DMD8: EU Cooperation on HTA and beyond - Current Action and Future Developments E2 #DMD9: Brexit and the European Network: 1,5 months to go! Where Do We Stand? F1

10:15

#CHS01: New Legislative Requirements in PV: How to Be More Efficient and Minimise Resources Content Hub 2 #CB2: Coffee Break in the Exhibition Hall Exhibition Hall #PS04: Oral Poster Session 4 - Regulatory Science & Value and Access Content Hub Content Hub 4

10:45

#CH101: Finding The Right Formula – The Ups and Downs of a Consumer Group’s Work With Industry 2010-2018 Content Hub 1 #CH301: Development of an Algorithm to Detect Antibiotic-induced Acute Kidney Injury Using Electronic Medical Records Content Hub 3 #S0101: Optimising Orphan Drug Development in the EU E1 #S0201: The Digital Transformation in Regulatory Affairs – What is Hype and What is Real? G1 #S0301: Impact of Pharmacovigilance on Public Health E2 #S0401: Re-Thinking Clinical Development DIAlogue Space #S0501: The Added Value of Medical Functions: Building a Long-Term Strategy G2 #S0601: From Faster Regulatory Approval to Actual Patient Access: What Could be Done to Increase Certainty around Clinical Benefit and Predictability of Decision Making? K1 #S0701: Digital Disruptors: What Do We Mean? F2 #S0801: The Impact of Innovation and Novel Pathways: The Role of the Regulator K2 #S0901: Clinical Trials and GDPR F1

11:15

#CH102: The Language of Patients Meets the Language of Safety Science Content Hub 1 #CH302: AI on the Rise - digitally transforming pharma’s regulatory processes Content Hub 3 #CH402: Policy 0070 Submissions – Comparison of Anonymisation Methodologies – Advantages and Disadvantages Content Hub 4

12:00

#CH103: EUPATI Update Content Hub 1 #CH403: Bridging the Gap between Managed Healthcare and Clinical Research Content Hub 4 #S0102: Optimising Paediatric Drug Development in the EU E1 #S0202: How Can the EU Regulatory Network Support Innovation? F2 #S0302: Forum on Global Pharmacovigilance E2 #S0402: Where Will Patients Come from in the Future? EHR and Biobanks F1 #S0502: Creating Value for Patients G2 #S0602: Incorporation and Acceptance of Real World Evidence in Market Access Discussions – Case Studies K1 #S0702: Blockchain in Healthcare and Pharma DIAlogue Space #S0802: Driving for Regulatory Excellence in Turkey K2 #S0902: Next Generation Sequencing-Based Comprehensive Genomic Profiling: A Paradigm Shift in Clinical Practice G1 #LOT02: How is R&D Being Reflected in Academia vs Industry 0.96-0.97 (Level 0)

12:30

#CH406: Unmet Medical Need Papers Content Hub 4

13:15

#L2: Lunch in the Exbition Hall Exhibition Hall

13:30

#LS01: Debate: Does the Future Legislative Framework in the EU Need Transformative Legislative change? Or Have We ‘Almost Got It Right’? DIAlogue Space

14:15

#PS05: Oral Poster Session 5 - Translational Medicines and Science & Data and Data Standards Content Hub Content Hub 3 #LOT00: Meet & Greet with Senior Experts

14:45

#CHS04: Navigating the Regulatory Landscape for Safety Reporting in Clinical Trials: Key Principles, Best Practices, and Upcoming Automation Content Hub 2

15:15

#CH201: Recent Developments and Possibilities in Using CPRD as a ‘Real World Data Source’ Content Hub 2 #CH404: EMA Policy 0070 - Arguing for a Pro-Active Anonymisation Process and External Validation of Identification Risk and Utility Content Hub 4 #S0103: The Regulatory Role in EU Public-Private Partnerships (PPPs) E1 #S0203: Precision Medicine: Gene-Editing, Advance Therapies and Personalised Medicine K2 #S0303: The New EudraVigilance System: One Year After E2 #S0403: Change is Coming… Getting the Questions Right in Clinical Development F1 #S0503: Medical Functions Contribution to Benefit-Risk Assessment G2 #S0603: Value Assessment of Combinations in Oncology (or others): Questions and Steps toward Practical Solutions K1 #S0703: The Digital Transformation of Clinical Trials and its Regulatory Implications – What are the Challenges? F2 #S0803: Updates from the Middle East Region: Key Insights from Agencies & Industry on the Regulatory Environment, Opportunities and the Challenges; Sharing Best Practices of Reliance Model Implementation G1 #S0903: Histology-Independent Indications DIAlogue Space #LOT04: Value and Access 0.96-0.97 (Level 0) #SP01: Nanomedicines and Nanosimilars – Implications for Regulators, Payers and Prescribers 0.11-0.12 (Level 0)

15:45

#CH202: Collaborating to Solve the Industry’s Toughest Challenges: Maximizing the Regulator-Sponsor Relationship Content Hub 2 #CH405: Aligning expectations for product label terminology: disease modification in neurodegenerative disorders as a case example Content Hub 4

16:15

#CB3: Coffee Break in the Exhibition Hall Exhibition Hall #PS06: Oral Poster Session 6 - Clinical Development & Pharmacovigilance Content Hub Content Hub 2

16:45

#CH303: Repurposing - Working Together on New Uses for Old Drugs Content Hub 3 #S0104: Evidence Generation as a Continuum: Can We Benefit from Advice? DIAlogue Space #S0204: Patient Preferences – The Science of Tomorrow G1 #S0404: Study Design and Innovative Statistics F1 #S0504: Dialog with Patients - Moving Forward with Digital Information G2 #S0604: Outcomes Measurement: The Key to Value-Based Healthcare K1 #S0704: Digital Innovation is Revolutionising All Aspects of Trial Execution: Opportunities and Requirements F2 #S0804: Update on PMDA’s Activities K2 #S0304: Decision Science, Communication and Pharma Comparing Older People to Younger Ones with Regard to Making Decisions about Taking Pharmaceuticals TBD #S0904: Fighting Falsified Medicines in Europe –Supply Chain Digitalisation for the Benefit of Patients: Are You Ready? E1 #LOT03: Regulatory Affairs: Career Opportunities and Field Development 0.96-0.97 (Level 0)

17:15

#CH304: New Changes to the National Drug Code in the U.S. Content Hub 3

18:00

#NW02: Networking Reception in the Exhibition Hall Exhibition Hall