Agenda

Day 1 Mar 19, 2020

9:00 AM — 10:15 AM

Integrating patient voice into value discussions and monitoring outcomes: key considerations from an EU perspective?

Day 2 Jun 28, 2020

11:00 AM — 12:00 PM

DIA Europe 2020 Virtual Meeting Orientation

5:00 PM — 5:00 PM

CXL - On-Demand: Data Analytics in Clinical Operations - Benefits and Practical Applications (Workshop)

Day 3 Jun 29, 2020

8:30 AM — 9:30 AM

Opening Keynote

9:30 AM — 10:30 AM

ICMRA, the hub of international collaboration on COVID-19’

10:30 AM — 11:30 AM

Biologicals and Biosimilars – Science versus Regulation

12:00 PM — 12:30 PM

Bayer - Shaping the Future to Meet Our Needs – A Digital Transformation

12:30 PM — 1:30 PM

Enabling Translation of Research and Innovation into Regulatory Standards

12:30 PM — 1:30 PM

What the Day after Tomorrow Will Look Like When Patient Engagement in Medicines R&D Is Systematic, Meaningful and Sustainable

1:30 PM — 2:30 PM

How Regulatory Science Shapes Policy

1:30 PM — 2:30 PM

Optimising the empowerment of informed decision making through innovative, transparent and contextualized communication of safety information

2:30 PM — 3:30 PM

Comparing accelerated approval pathways among EMA, FDA and PMDA

2:30 PM — 3:30 PM

Drug Development Tools in a Digital Era

4:30 PM — 5:30 PM

Advancing effective use of digital health technologies in Parkinson’s Disease

5:30 PM — 6:30 PM

Making Patient Engagement the New Normal: Real World Realities for Working with Patients

Day 4 Jun 30, 2020

9:00 AM — 10:00 AM

EUnetHTA Town Hall – Value: How is the Value of a Health Care - Innovation Established and Can Different Stakeholders See the Same Value?

9:00 AM — 10:00 AM

Pharmacovigilance Regulations: Updates

10:00 AM — 11:00 AM

“ICH clinical trials and pharmacovigilance - preparing for the future”

10:00 AM — 11:00 AM

Taking Stock on Parallel Consultation & Early Access Developments

11:00 AM — 12:00 PM

From Indication-Based Labels to a New Era of Evidence Generation – What Are the Future Roles of Regulators and HTA Bodies?

11:00 AM — 12:00 PM

Patient Involvement in the Development and Safe Use of Medicines

12:00 PM — 1:00 PM

Are current HTA processes suitable for innovative cancer medicines?

1:00 PM — 2:00 PM

Drug Assessment for Regulatory and HTA Purposes: Similarities and Differences, the Way Forward

1:00 PM — 2:00 PM

Healthcare 2030 – A Shared Ambition for Better Health for European Citizens

1:00 PM — 2:00 PM

Pharmacovigilance 'Then and Now' - How Has PV Changed?

2:00 PM — 3:00 PM

Navigating Multiple Stakeholder Perspectives on Clinical HTA Methodological Standards for EU Joint Assessments beyond 2020

2:00 PM — 3:00 PM

Preparing health systems for integrated and personalised care

2:00 PM — 3:00 PM

Update on ICH Safety Topics

3:00 PM — 4:00 PM

From discovery to patient access: how can Europe remain at the forefront of innovation in the development of diagnostics and therapies in rare diseases, and ensure patients benefit from the next hundreds of treatments?

3:00 PM — 4:00 PM

How will PREFER Patient Preference Studies Inform Decision-Makers about Patients’ Needs and Preferences

4:00 PM — 5:00 PM

Personalised Healthcare: A Systems Upgrade Worth Investing In?

Day 5 Jul 01, 2020

9:00 AM — 10:00 AM

Big Data Task Force: So what happens next?

10:00 AM — 11:00 AM

The Future of Healthcare is Digital, Genomic and Collaborative- Is the EU Policy and Regulatory Framework Ready? How Can Emerging Technologies Be Transforming?

11:00 AM — 12:00 PM

How Do We Realise the Benefits of Data Sharing While Maintaining Patient Trust?

12:00 PM — 12:30 PM

Simultaneous National Scientific Advice – a pilot for a joint European approach

12:30 PM — 1:00 PM

Annual Industry Report: Trends, Insights, and Strategies to Modernize Clinical Operation

1:00 PM — 2:00 PM

A Development Support Environment in Europe that Adapts to the Future Challenges of Innovation – Needs and Expectations

1:00 PM — 2:00 PM

Is Europe ready to define quality standards for Real World Data (RWD) sources?

2:00 PM — 3:00 PM

Case Studies in Applying Artificial Intelligence or Machine Learning

2:00 PM — 3:00 PM

Clinical Trials Go Digital – Advantages and Challenges

3:00 PM — 4:00 PM

Clinical Trials Go Digital – Electronic Endpoints: Opportunities and Challenges

3:00 PM — 4:00 PM

Pre-competitive collaborations, a path to improving real world evidence (RWE) development efforts in service of patients

4:00 PM — 5:00 PM

Complex Clinical Trials – Driving Innovation

5:00 PM — 6:00 PM

Clinical Trial Regulation: State of Play – Are We Ready?

6:00 PM — 7:15 PM

Industry - Regulator Dialogue: Tailor-made Regulatory Guidance for Non-clinical to Clinical Development

7:15 PM — 7:30 PM

On-Demand: A Dynamic Regulatory Ecosystem to Support Big Data Opportunities

7:15 PM — 7:30 PM

On-Demand: Access, Medical Devices, Medical Affairs and HCP, Regulatory Submission

7:15 PM — 7:30 PM

On-Demand: Clinical, Clinical Operations, Pharmacovigilance and Data

7:15 PM — 7:30 PM

On-Demand: Clinical, Clinical Operations, Pharmacovigilance and Data - Content Hub Session

7:15 PM — 7:30 PM

On-Demand: Global Regulatory Landscape for Aggregate Safety Assessments

7:15 PM — 7:30 PM

On-Demand: Regulatory Science Hub Session

Day 6 Jul 02, 2020

9:00 AM — 10:00 AM

Coordinated European Approach to Solve the Problem of Shortages – Is It Possible?

10:00 AM — 11:00 AM

Regulations and Enforcement Impacting Medicine Manufacturing and Supply in a Globalised Context

10:35 AM — 11:45 AM

Clinical, Clinical Operations, Pharmacovigilance and Data s - Content Hub Session

11:00 AM — 12:00 PM

Ensuring Quality throughout the Supply Chain – Update on nitrosamine impurities case

12:00 PM — 1:00 PM

Lunch & Learn On-Demand: DA Spotlight - Top 10 Lessons Learned on Regulatory Science from the Opioid Epidemic

1:00 PM — 2:00 PM

ICH at 30 - What Will Come the Next 30 Years?

1:00 PM — 2:00 PM

MDR Implementation – Status Quo

2:00 PM — 3:00 PM

RA Leadership Forum: Critical Deliverables in Global Regulatory Teams

3:00 PM — 4:00 PM

Bringing down barriers for access for gene and cell therapies in Europe

3:00 PM — 4:00 PM

ISO 14155: 2020 Revision of Medical Devices Good Clinical Practice

4:00 PM — 5:00 PM

At the interface of two EU legislations – Multi stakeholder efforts to implement MDR Article 117 for drug delivery combinations

5:00 PM — 6:00 PM

Mind the Gap - Disentangling the Maze of Drug-Device Combination Product Approval in the EU

Day 7 Jul 03, 2020

9:00 AM — 10:00 AM

Chat with Professionals

10:00 AM — 11:00 AM

Understanding and Applying the ICH E17 Guideline on Multiregional Clinical Trials (MRCT): A Regulator’s and Industry Perspective

11:00 AM — 12:00 PM

How to promote patient centricity ? - Based on experiences of clinician and head of regulatory agency

12:00 PM — 1:00 PM

Lunch & Learn

12:00 PM — 12:30 PM

Lunch & Learn: Patient Innovation in Clinical Research: It’s time to get personal

1:00 PM — 2:00 PM

Digitisation of Systems and Technology (AI)

1:00 PM — 2:00 PM

Does the current regulatory framework enable future science and technology along the product lifecycle?

2:00 PM — 3:00 PM

Can we run studies with less Site Visits?

2:00 PM — 3:00 PM

Digital Transformation

3:00 PM — 4:00 PM

Promising digital tools for simplifying variations- how to connect dots and to make it happened?

4:00 PM — 5:00 PM

Telematics Strategy in the EU: Global and Regional Considerations for 2020-2025

5:00 PM — 6:00 PM

Effective Outsourcing in Regulatory Operations

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DIA EUROPE 2020

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