Agenda

Day 1 Feb 17, 2021

5:00 PM — 6:00 PM

Platform Orientation Session

Day 2 Mar 15, 2021

9:00 AM — 9:15 AM

Opening Session

9:15 AM — 10:30 AM

Health Emergency Preparedness

11:00 AM — 12:00 PM

Broadening the Vision – Bringing Imaging Into the Mainstream

11:00 AM — 12:00 PM

COVID-19: Lessons Learnt so far in the Regulatory and R&D

11:00 AM — 12:00 PM

Novel Manufacturing Approaches for Early Access and Sustained Supply

11:00 AM — 12:00 PM

Spotlight on China Regulatory Reform and Acceleration in Simultaneous New Drug Development

11:00 AM — 12:00 PM

Vaccination: Exploring Risk Communication Needs

12:00 PM — 1:00 PM

Round Table Session - Use of Holistic Program Management to Foster Client Vendor Interaction - Closed Session

12:00 PM — 12:30 PM

Speed Networking

1:00 PM — 1:45 PM

Keynote: Transforming Healthcare Through Genomics and Precision Medicine

1:45 PM — 2:15 PM

Optimising Collaboration Between EMA and FDA for Your Development Activities

2:15 PM — 3:15 PM

Building Frameworks to Make the Promise of Personalised Healthcare a Reality by Enabling Healthcare Systems

2:15 PM — 3:15 PM

Globalisation of Pharmacovigilance and Impact of COVID-19 Pandemic

2:15 PM — 3:15 PM

In Vitro Diagnostic Regulation (IVDR) In The Context of Clinical Trials and Upcoming Clinical Trial Regulation (CTR)

2:15 PM — 3:15 PM

Round Table: Precision Diagnostics - From Single to Comprehensive Testing and Multiple Drug Selection

4:00 PM — 5:15 PM

Big Data 2021: Delivering Transformation in Data-Driven Medicines Regulation

4:00 PM — 5:30 PM

What does Good Look Like? Shaping the Environment to Manage Antimicrobial Resistance and Promote Sustainable Development of Anti-infectives and Vaccines

5:00 PM — 5:20 PM

Podcast: TriloTalk by Trilogy Writing & Consulting - Episode 1: Lean Medical Writing

5:15 PM — 6:00 PM

Networking - Bingo Get to Know the Exhibitors & Round Table Discussion

5:30 PM — 6:00 PM

Transforming Regulatory Affairs

6:00 PM — 7:00 PM

Digital Health in a Post-COVID-19 Era: How the COVID-19 Pandemic Changed Regulatory Frameworks Around Telehealth and AI

6:00 PM — 7:00 PM

FDA Townhall

6:00 PM — 7:00 PM

How Can We Address AMR “Broken Business Model” to Activate Antibacterial R&D? Policy Needs, Potential Solutions and Examples

6:00 PM — 7:00 PM

Opportunities and Challenges of Novel Clinical Endpoints and Approaches Enabling Personalised Healthcare

6:00 PM — 7:00 PM

Organic Compliance: Preparing Academics for a Connected, Compliant, and Digital Future

Day 3 Mar 16, 2021

9:00 AM — 10:15 AM

European Medicines Regulatory Network Strategy to 2025

9:00 AM — 10:15 AM

Learning from Novel Regulatory Approaches During the COVID Pandemic and Opportunities for the Future

11:00 AM — 12:00 PM

Advancing Patient-centred Development and Access to Medicines in Partnership with Healthcare Systems

11:00 AM — 12:00 PM

Enabling Cell and Gene Therapies: Creating an Appropriate Framework

11:00 AM — 12:00 PM

Opportunities for Regulatory Dialogue to Accelerate Innovation in the EU

11:00 AM — 12:00 PM

PMDA Updates

11:00 AM — 12:00 PM

Seeing Through the Fog of a Pandemic: Building Evidence in Record-Time Through Interventional and Non-Interventional Studies

12:00 PM — 1:00 PM

PharmaLedger - Demonstrating the vision of Blockchain Enabled Healthcare

12:00 PM — 12:30 PM

Speed Networking

1:00 PM — 2:30 PM

EU Regulatory Town Hall: Stress Testing Under COVID-19 - Is the European Framework Agile Enough?

2:00 PM — 2:50 PM

Poster Session 1 – Regulatory and Health Policy

3:00 PM — 4:00 PM

ATMP Regulation 2.0 – Is the System Fit as is?

3:00 PM — 4:00 PM

Bringing Trials Closer to Patients: Leveraging Innovative Technologies and Approaches

3:00 PM — 4:00 PM

Trans-Diagnostic Drug Development Beyond Oncology

3:00 PM — 4:00 PM

Value Communications and Negotiations – Are You Prepared?

4:00 PM — 4:30 PM

Endotype Approach for Drug Development

4:30 PM — 5:30 PM

De-risking Regulatory Strategy for ATMPs

4:30 PM — 5:30 PM

Harmonising Structured Data in Module 3 to Standardise Terminologies and Submission Standards

4:30 PM — 5:30 PM

Unmet Medical Need

5:30 PM — 6:00 PM

Increasing Complexity of Clinical Trials in Oncology: A Case Study of Importance of Optimal Patient Selection

6:15 PM — 7:30 PM

Advancing Complex Innovative Clinical Trial Designs – Opportunities for Global Regulatory Convergence in Oncology

6:15 PM — 7:15 PM

Digital Technologies and Their Promise of Increased Technical Success, Reduced Timelines and Broader Generalizability of Findings

6:15 PM — 7:15 PM

Emerging Technologies and Data Driven Initiatives within the Regulatory Environment

6:15 PM — 7:15 PM

GMPs for Investigational Products to Enable Rapid Patient Access

6:15 PM — 7:15 PM

Strategies to Implement Routine Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process

Day 4 Mar 17, 2021

9:00 AM — 10:15 AM

Medicines Shortages Changing the Paradigm from Mitigation to Prevention

9:00 AM — 10:15 AM

Raising the Bar of Patient Engagement – Patient Centric Innovation and Patients’ Role In Medicine Development and Decision Making

10:15 AM — 11:00 AM

Poster Session 2 – Safety and Pharmacovigilance

11:00 AM — 12:00 PM

Effective Risk Communication for Safe Use Behaviors in Healthcare: Innovation Through Formative and Evaluative Collaborations

11:00 AM — 12:15 PM

Opportunities and Challenges of RWE to Support Regulatory Decision-Making

11:00 AM — 12:00 PM

RWE4 Decisions

11:00 AM — 12:15 PM

Updates from The Middle East – A Leap Forward in Digitalization and Steps Towards Faster Access

12:00 PM — 1:00 PM

Managing What Matters. How to Create Patient Access to (Neo)Adjuvant Treatments

12:00 PM — 12:30 PM

Speed Networking

1:00 PM — 2:00 PM

Beyond PROs and Organized Protests: How Can We Bring the Patient Voice into HTA Decision-Making?

1:00 PM — 2:00 PM

Building Effective Collaboration for Mutual Value Creation in Healthcare

1:00 PM — 2:00 PM

Early Access CMC Approaches: EMA Toolbox Guidance 2021

1:00 PM — 2:00 PM

IDMP as a Cornerstone in Digital Transformation for Regulatory Practice in Europe

1:00 PM — 2:00 PM

Take International Collaboration in Paediatrics to the Next Level to Accelerate Access to Paediatric Medicines

2:00 PM — 2:30 PM

The Value of Strategic Partnerships: From Nice to Have to Necessity

2:30 PM — 3:45 PM

EUnetHTA Town Hall - After Three Joint Actions with EUnetHTA – Which are the Main Achievements and the Remaining Challenges?

2:30 PM — 3:45 PM

Pharmaceutical science, innovation and social policy 2030

3:45 PM — 4:15 PM

A Digital Channel Pharmacovigilance Requirements Database with Integrated Robotic Process Automation (RPA)

4:00 PM — 4:20 PM

Advancing Nanomedicines Into the Clinics by Applying a Multidisciplinary Approach

4:00 PM — 4:20 PM

Arisglobal Webinar: Overcome Site Regulatory (ISF) Issues

4:30 PM — 5:45 PM

Difficulties Predicting Safety and Dose in FIH Setting: Options When There are No Options, an Industry and Regulator Perspective

4:30 PM — 5:30 PM

Aggregate Safety Assessment Planning and Estimands for Safety Evaluation in the context of COVID-19

4:30 PM — 5:30 PM

Testing the Readiness of The Framework: Are The Regulatory Processes Fit for Rapid Development of Treatments and Vaccines?

4:30 PM — 5:30 PM

Turkey: Building the Role of a new ICH member in Global Regulatory Communities

5:30 PM — 6:00 PM

COVID-19 and Beyond: The UK's Research Response to COVID-19 and Next Steps

5:30 PM — 6:15 PM

Networking - Round Table Discussion

6:15 PM — 7:15 PM

How Mechanism of Action-Driven Development Can Address the Covid-19 Challenge

6:15 PM — 7:15 PM

Laying the Foundation for a Value-Based, Patient-Centered, and Outcome-Driven Healthcare System in Europe

6:15 PM — 7:15 PM

Regulatory Science Dialogue

6:15 PM — 7:15 PM

The Importance of Data Management and CDISC/IDMP Data Standards for First Time Right Submissions

Day 5 Mar 18, 2021

9:00 AM — 10:00 AM

Attributing Value to Innovation: Which Evidence is Needed to Satisfy Different Decision-Making Methodologies?

9:00 AM — 10:00 AM

Cloud-based Submissions; from Principles to Practice

9:00 AM — 10:00 AM

Methodologies for Incorporating the Patient Voice in Development and Regulatory Processes

9:00 AM — 10:00 AM

Understanding of Different Set Ups of PPP, Benefits of PPPs and Learnings of Recent Projects to Facilitates Future Success of Such Collaborations

10:00 AM — 10:30 AM

Researches to Utilize Administrative and Claims Data as A Real-World Data for Regulatory Purpose

10:45 AM — 12:00 PM

Alternative GMP/GDP Inspection Practices: Opportunities implementing Lessons Learned from a Pandemic Situation (COVID-19)

10:45 AM — 12:00 PM

Changes in PV and the Impact of EU PV Legislation on Patient Safety

10:45 AM — 11:45 AM

Patient Involvement in Patient Preference Studies: Lessons from the IMI PREFER Project

10:45 AM — 12:15 PM

Sustaining Regulatory Systems in Africa – The Value of Reliance and Collaboration

10:45 AM — 11:45 AM

Transformative Disruption to Regulatory Submissions and Approvals: Accumulus Synergy

12:00 PM — 12:30 PM

Speed Networking

12:00 PM — 1:00 PM

The Digital Future of R&D – Strategies for Data, Automation and Artificial Intelligence (NNIT)

1:00 PM — 2:00 PM

Comparison of Emergency Use Pathways Among Japan-the US-Europe: Including Post-Marketing Management

1:00 PM — 2:00 PM

Nitrosamines: Traceability / Sensitivity - What is Good Enough?

1:00 PM — 2:15 PM

Reliance: The Key to Smart Regulation?

1:00 PM — 2:00 PM

Scientific Advice and Collaboration with Academia as Tools to Facilitate Research and Development of New Medicines

2:00 PM — 2:30 PM

Monitoring and Surveillance in the Marketing of Medical Devices

2:30 PM — 3:45 PM

COVID-19, An Opportunity to Step Up International Collaboration

2:30 PM — 3:45 PM

ICH E17 Guideline on Multi-Regional Clinical Trials: A Catalyst for Simultaneous Global Development and Registration

3:45 PM — 4:30 PM

Poster Session 3 – Clinical Development & Value and Access

4:30 PM — 5:45 PM

Advances in Evidence-based Quality and Risk Management for Pharmacovigilance Decisions Making

4:30 PM — 5:30 PM

Improving Access to Medicines: Exploring New Regulatory Frameworks for Letting Data Lead the Way to Increased Drug Options

4:30 PM — 5:45 PM

Multi-stakeholder Collaborations to Drive Adoption and Alignment in the Implementation of Telemedicine Platforms and the Use of Digital Measures

4:30 PM — 5:30 PM

Paving a New Road for Digital Health – Global Trends in Software Regulation

4:30 PM — 5:30 PM

STARS: Strengthening Regulatory Science in academia – an EU initiative to bridge the translational gap

6:15 PM — 7:15 PM

Clinical Operations for Studies Involving Special Populations and Adaptive Designs

6:15 PM — 7:15 PM

MHRA Townhall: MHRA globally - Past, Present and Future

6:15 PM — 7:15 PM

Predictive Stability– How Do We Move To A Risk Based Approach For Providing Required Stability Data, Platform Data, Extrapolation etc Linking Bio/Chemical Approaches By Science

6:15 PM — 7:15 PM

The Use of Remote Monitoring Technologies:a review of recent regulatory scientific advices, qualification opinions and qualification advices issued by the EMA

Day 6 Mar 19, 2021

9:00 AM — 10:00 AM

Engaging in the EU Regulatory Network: Member State Journeys

9:00 AM — 10:00 AM

Healthcare Priorities: What Additional Funding Choices Should Decision-Makers Take Based on COVID-19 Impact on CNS Disorders?

9:00 AM — 10:00 AM

Singapore Townhall

9:00 AM — 10:00 AM

Using Emerging Technologies and Electronic Data Sources for Conducting Trials

10:00 AM — 10:30 AM

COVID-19 and Beyond: Delivering Complex and Innovative Trials

10:45 AM — 11:45 AM

Cross-border Access to ATMPs in the European Union

10:45 AM — 12:00 PM

Refocus on Unmet Public Health Challenges – Who should Lead the Way?

10:45 AM — 11:45 AM

Regulatory Affairs Lessons Learned in the Crucible of COVID-19: What Works and What Could Work

10:45 AM — 11:45 AM

The Eurasian Union Regulatory Framework - Now a Reality

12:00 PM — 1:00 PM

PharmaLedger - Data Privacy and the vision of a Blockchain Enabled Healthcare

12:00 PM — 12:30 PM

Speed Networking

1:00 PM — 2:00 PM

Digital Clinical Data Generation, Incorporation Into Regulatory Decision Making (Parkinson’s Disease, MS)

1:00 PM — 2:00 PM

Digital Risk Minimization Tools

1:00 PM — 2:00 PM

ePI – Setting Tomorrow’s Labelling and Regulatory Operations Framework

1:00 PM — 2:00 PM

Robust Clinical Trials in the Future Incorporating Learnings from the Covid-19 Pandemic

1:00 PM — 2:00 PM

Unlock the Potential of Emergent Cell Therapies

2:00 PM — 2:30 PM

Imaging Biomarkers, Where to Begin? Optimizing Trial Portfolio Strategies to Accelerate Drug Approval

2:30 PM — 4:00 PM

EMA 2030 and beyond - How should the EMA of the Future look like - Stakeholder Expectations

2:30 PM — 3:45 PM

The Use of Artificial Intelligence/ Machine Learning in Pharmacovigilance

4:00 PM — 4:15 PM

Closing Session

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DIA EUROPE 2021

Agenda

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