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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

DIA EUROPE 2018

Agenda

9:00 AM — 12:30 PM

Genomics in Clinical Development

9:00 AM — 12:30 PM

Genomics in Clinical Development

9:00 AM — 10:30 AM

IMI PREFER: Patient Perspective in Benefit-Risk Assessments during the Medical Product Life Cycle

9:00 AM — 10:30 AM

Leader of Tomorrow: Veni.Vidi.Dici

9:00 AM — 12:30 PM

The Science of Lay Language Communication Applied in a Pharmaceutical Context: Readability and Understanding of Documents

9:00 AM — 12:30 PM

The Science of Lay Language Communication Applied in a Pharmaceutical Context: Readability and Understanding of Documents

9:00 AM — 10:30 AM

WHO/Swissmedic Signature Session - Towards Access 2030: How Can Strengthening of Regulatory Systems Contribute?

11:00 AM — 12:30 PM

European Regulatory Town Hall Meeting: EMA Relocation and Implication for Centralised Activities

11:00 AM — 12:30 PM

International Pharmacovigilance

11:00 AM — 12:30 PM

Leader of Tomorrow: Creating Relevant Opportunities

11:00 AM — 12:30 PM

Payer Town Hall Meeting: WHO Fair Pricing

1:00 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) Guideline

1:00 PM — 1:45 PM

EFPIA Spotlight: Pharmaceuticals in the Environment

2:00 PM — 3:30 PM

Major Reforms and Strengthened International Cooperation – What Is Happening in China?

2:00 PM — 3:30 PM

Realising the Potential of Future Biomedical Innovation: The Role of Intensified EU Cooperation on HTA

2:00 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 Healthcare

8:30 AM — 10:00 AM

Evidence Generation in Medicines Development for Rare Patient Populations: Challenges and Opportunities

8:30 AM — 10:00 AM

Exploring Use of Artificial Intelligence: Trust in Technology, or Trust in Each Other?

8:30 AM — 10:00 AM

NCA Showcase: Brexit Implications for the EU27 Network and Decentralised Activities

8:30 AM — 10:00 AM

Patient Centricity beyond the Talk

10:30 AM — 12:00 PM

Collaboration across Decision Makers to Facilitate Patient Access: Recent Advances and Future Needs

10:30 AM — 12:00 PM

EMA Proactive Transparency – Clinical Data Publication (Policy 0070)

10:30 AM — 11:00 AM

Endpoints in Clinical Research

10:30 AM — 12:00 PM

Enhancing Benefit-Risk Management through the Product Life Cycle

10:30 AM — 12:00 PM

Fighting the Fakes – Preparing for Upcoming EU Medicine Serialisation

10:30 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 Landscape

10:30 AM — 12:00 PM

Learnings from the First 10 years of the Paediatric Regulation –Back to Inform on the Future?

10:30 AM — 12:00 PM

New European Clinical Trial Regulation: A New Paradigm with Major Impact on Clinical Trial Stakeholders

10:30 AM — 12:00 PM

Novel Therapeutic Approaches

10:30 AM — 12:00 PM

Update on PMDA’s Activities

11:15 AM — 11:45 AM

Less than Perfect? Clinical Efficacy Data Supporting Approval of New Drugs: Focus on Approvals Based on a Single Pivotal Trial

12:30 PM — 1:30 PM

ADAPT SMART Spotlight

12:30 PM — 1:30 PM

TransCelerate Spotlight: How is Multi-Stakeholder Collaboration Driving Industry Change

2:00 PM — 3:15 PM

Data Sharing and Secondary Use of Data

2:00 PM — 3:15 PM

Digital Health : What is the Landscape Looking like for Medicines?

2:00 PM — 2:30 PM

Enabling and Constraining Factors in Commercial ATMP Development: Learnings from the Escher-ATMP study

2:00 PM — 3:15 PM

ICMRA – The Future of Medicines and Challenges for International Regulators

2:00 PM — 3:15 PM

Innovative Approaches to Safety Information

2:00 PM — 3:15 PM

New Collaboration Models with Regulators and Patients

2:00 PM — 3:15 PM

Paediatric Policy Initiatives: Globalisation of Paediatric Drug Development Best Practice or Imperialism of Practice?

2:00 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 — 3:00 PM

Regulatory – How to Submit a Combination Product or Drug Device Combination Globally

2:00 PM — 3:15 PM

Regulatory Access Pathways to Facilitate Early Access and HTA Synergies

2:45 PM — 3:15 PM

Key Learnings from the First European Patient Advocacy Advisory Board for Leber’s Hereditary Optic Neurotherapy (LHON)

3:15 PM — 4:00 PM

E&E: The Shared Investigator Platform – Revolutionising Communication Between Sites & Sponsors

4:00 PM — 5:30 PM

Challenges in the Current Regulatory Landscape Considering FDA and MDR Expectations

4:00 PM — 5:30 PM

Drawing the Boundaries of Data Disclosure in Clinical Trials

4:00 PM — 4:30 PM

Drivers, Barriers, and Benefits of a Unified Clinical Operating Model

4:00 PM — 5:30 PM

Enhancing Evidence Generation across the Product Life Cycle

4:00 PM — 5:30 PM

Health Economics of Future Therapeutic Concepts

4:00 PM — 5:30 PM

Measuring Impact of Pharmacovigilance in the EU

4:00 PM — 5:30 PM

Needed Competencies for Big Data – Learning from Other Industries

4:00 PM — 5:30 PM

Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future

4:00 PM — 5:30 PM

Reliance and Work Sharing @ Work – State of Play and Hands-On Experience from Two Case Studies

4:00 PM — 5:30 PM

Russia and the Eurasian Union – Regulatory Challenges and Opportunities

4:00 PM — 5:30 PM

The New Data Ecology - How to Incentivise and Enable More Sharing of Data?

4:45 PM — 5:15 PM

The Master’s Data Management from the ‘Single Place of Truth’

8:30 AM — 10:00 AM

ATMPs

8:30 AM — 10:00 AM

Collaborative Frameworks and Public Private Partnerships as Drivers of Innovation

8:30 AM — 10:00 AM

DIAlogue: The Role of Unmet Need in Regulatory and Pricing Decision Making

8:30 AM — 10:00 AM

Five Years On – Pharmacovigilance Legislation Delivers on Long-Promised Elements

8:30 AM — 10:00 AM

GMP Convergence – A Key Part of Regulatory System Strengthening

8:30 AM — 10:00 AM

ICH Info Day Part 1

8:30 AM — 10:00 AM

Life Cycle Management Activities of Drug Device Combinations

8:30 AM — 10:00 AM

Making Clinical Trial Information Accessible: Experiences in Developing Informed Consent Forms and Lay Summaries of Study Results

8:30 AM — 10:00 AM

Overview of Major Big Data Projects across EU, US, Japan

8:30 AM — 10:00 AM

Smarter Clinical Trials with Real World Evidence Data

8:30 AM — 10:00 AM

Value and Access – How Do We Strike a Balance between Both?

9:15 AM — 9:45 AM

How Partnering with the Regulatory Intelligence Function Enables Innovative Regulatory and Drug Development Strategies

10:30 AM — 12:00 PM

Benefit/Risk Communication Tools that Work: Towards a Tailor-Made Drug Facts Box?

10:30 AM — 12:00 PM

Big Data Mandates Strict Data Governance

10:30 AM — 12:00 PM

ICH Info Day Part 2

10:30 AM — 12:00 PM

Impact of Human Factors on the Development of Combination Products

10:30 AM — 12:00 PM

Key Initiatives in Europe to Walk the Talk in Patient-Focused Medicines Development - An interactive update and Discussion with Different Stakeholders

10:30 AM — 12:00 PM

Life Cycle Management – The Unknown Barrier to Access

10:30 AM — 12:00 PM

Precision Medicine and Personalised Healthcare

10:30 AM — 12:00 PM

Sustainability of Health Care Funding - Are We Prepared for Tomorrow's Funding Challenge?

10:30 AM — 12:00 PM

The Promise and Reality of Clinical Trial Transparency Initiatives

10:30 AM — 12:00 PM

Turkish Regulatory Session

1:00 PM — 2:00 PM

Conference Insights and Outcomes – Rapid Fire Session

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