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Square Brussels Convention Centre

Mar 12, 2024 9:00 AM - Mar 14, 2024 4:00 PM

Glass Entrance, Mont des Arts/Kunstberg, 1000 Brussels, Belgium

DIA Europe 2024

Agenda

9:00 AM — 7:00 PM

Leader of Tomorrow 2024

9:00 AM — 10:30 AM

Opening Plenary and Keynote Address

10:35 AM — 10:55 AM

The Future of Regulatory Documentation with Generative AI

11:00 AM — 12:30 PM

EU Regulatory Townhall: The New Pharmaceutical Legislation – How Are We Setting the Stage for Availability and Access of Novel Healthcare Solutions?

11:00 AM — 12:20 PM

Focus Group: Are your collaborations ‘igniting change'? If so, how? If not, why?

11:00 AM — 12:30 PM

WHO Townhall - Navigating Regulatory Frontiers: WHO Listed Authorities, Facilitated Product Introduction, Strengthening Clinical Trials, and Efforts to Preserve Antimicrobials

12:40 PM — 1:40 PM

Challenges and Opportunities in Developing and Delivering Paediatric Clinical Trials

12:40 PM — 1:40 PM

Live Oral Poster Presentations I

12:40 PM — 1:40 PM

The Evolutionary Impact of Emerging Technologies Shaping the Future of the Life Science Industry.

12:50 PM — 1:10 PM

Elevating Regulatory Practices and Pharmacovigilance with Industry 4.0: A Comprehensive Exploration

1:20 PM — 1:40 PM

From global to local: the benefits of strategic outsourcing at different levels in facing regulatory challenges

1:50 PM — 3:00 PM

Africa Townhall - Operationalization of AMA: Building an Equitable, Sustainable Regulatory Ecosystem Across Africa

1:50 PM — 3:00 PM

AI in Medicines Lifecycle

1:50 PM — 3:00 PM

Collaborative Review & Reliance – Grasping the Opportunity

1:50 PM — 3:10 PM

DIA Startup Accelerator

1:50 PM — 3:00 PM

How To Stimulate Orphan Drug Innovation In Europe Under The New Legislative Framework

1:50 PM — 3:00 PM

International Regulation and Harmonisation: A Global Approach

1:50 PM — 3:00 PM

Risk Minimisation Measures: Future Collaborative Solutions in Europe

1:50 PM — 3:00 PM

South-Eastern Europe Townhall

2:00 PM — 3:20 PM

Focus Group: Are your collaborations ‘igniting change'? If so, how? If not, why?

3:05 PM — 3:25 PM

2024 EU elections: Towards a truly participatory, democratic, and impactful involvement of patient organisations

3:05 PM — 3:25 PM

AI-powered Data Extraction Practical Use Cases in Regulatory from the Field

3:30 PM — 4:50 PM

Complexity: Interplay and Interface of Different Legislations

3:30 PM — 4:40 PM

Darwin EU: How RWE Is Transforming Regulatory Decision Making?

3:30 PM — 4:40 PM

Deep Dive into the Impact of the New Pharmaceutical Legislation on Regulatory Operations: The Impact on Data, Technology, and Processes in Regulatory Affairs

3:30 PM — 4:40 PM

Futureproofing of the EU Clinical Trials Regulation (CTR)

3:30 PM — 4:40 PM

Middle East Townhall: Future-Proofing the Regulatory Framework

3:30 PM — 4:40 PM

PMDA Townhall

3:30 PM — 4:40 PM

Preference Studies in Regulatory and Payers' Decisions: Are We Ready?

4:45 PM — 5:05 PM

EU Horizon NextGen: Next Generation Innovation for Personalised Medicine in Cardiovascular Health

4:45 PM — 5:05 PM

Transitioning from Paper-Based to Digital Distribution of DHCPs and Educational Materials to Enhance Patient Care and Safety

5:00 PM — 6:20 PM

Focus Group: Are your collaborations ‘igniting change'? If so, how? If not, why?

5:10 PM — 6:40 PM

Digital Transformation in EU Regulatory Space  

5:10 PM — 6:40 PM

Driving R&D to Meet Societal Needs

8:30 AM — 10:10 AM

Workshop - Key Factors to Enable Digital Transformation in the EU Medicines Regulatory Space

9:00 AM — 10:10 AM

China Townhall

9:00 AM — 10:10 AM

Defining Unmet Medicinal Need and Implications for Regulatory Strategy

9:00 AM — 10:10 AM

Life-Cycle Management and CMC dossier

9:00 AM — 10:10 AM

Medical Devices in Clinical Trials

9:00 AM — 10:10 AM

MHRA Townhall

9:00 AM — 10:10 AM

Registries: Solving the Real Life Challenges

9:00 AM — 10:10 AM

RWE Supporting HTA/Payers Determine the Value of Highly Innovative Medicines

10:15 AM — 10:35 AM

Phased Reviews

10:15 AM — 10:35 AM

Progressing the Development of Disease-Modifying Medicines for the Prevention of Paediatric-Onset Prevalent Chronic Diseases

10:40 AM — 11:50 AM

Europe on the Biopharmaceutical Innovation Map

10:40 AM — 11:50 AM

Improving Applications for Conditional Approval of Cancer Drugs: Analysis of Experience, Attitudes, and Optimal Strategies

10:40 AM — 11:50 AM

Interactive Workshop: Upskilling for Successful Digital Transformations in Regulatory Affairs and Clinical Operations

10:40 AM — 11:50 AM

International Collaboration and Convergence on Guidance to Enable Real-World Evidence (RWE) for Regulatory Decision-Making

10:40 AM — 11:50 AM

IVDR (In-Vitro Diagnostics Regulation)

10:40 AM — 11:50 AM

Sustainability and CMC (Chemistry, Manufacturing and Controls)

10:40 AM — 11:50 AM

Thrive Through Reliance Implementation

12:00 PM — 1:00 PM

IHI in a Nutshell

12:00 PM — 1:00 PM

Levelling the Interaction Between Patients and European National Competent Authorities (NCAs) - Challenges & Possible Pitfalls

12:00 PM — 1:00 PM

Live Oral Poster Presentations II

12:00 PM — 1:00 PM

Optimizing Post-Approval Regulatory Lifecycle Management and Decoding the Future for Local QPPV

12:20 PM — 1:00 PM

New Regulatory Flexibility in the EU: The Value of Platform Technologies for Public Health

1:10 PM — 2:40 PM

ACT EU and the Future of Clinical Research in Europe

1:10 PM — 2:40 PM

European Medicines Agencies Network Strategy to 2028: Spotlight on Innovation, Availability & Shortages of Medicines

1:10 PM — 2:40 PM

Global Innovation in Manufacturing and CMC

2:45 PM — 3:05 PM

EDQM Strategy for 2024-2027 – Addressing Public Health Priorities and Challenges in a Continuously Evolving Environment

2:45 PM — 3:05 PM

From Planning to Performance: Unveiling the Success Metrics of Automating PV Projects

3:00 PM — 6:30 PM

Executive Forum - Invitation Only

3:10 PM — 4:20 PM

Clinical Trials with Decentralised Elements

3:10 PM — 4:20 PM

FDA Townhall

3:10 PM — 4:20 PM

Get to Decide: How to Lead Better Using Decision Science

3:10 PM — 4:20 PM

How to Build a Sustainable Pharmacovigilance Ecosystem?

3:10 PM — 4:20 PM

Integrating Environmental and Equity Considerations and Future-Proofing Health Care Systems

3:10 PM — 4:20 PM

Reimagining the Labelling End-to-End Process! The Case of the EU Centralized Procedure

3:10 PM — 4:20 PM

The Future of Precision Medicines: How the Regulatory Framework Keeps Up with Evolving Science

4:25 PM — 4:45 PM

Certified AL in Life Science Operations Sponsored by NTT DATA

4:25 PM — 4:45 PM

Trans and Gender Diversity in Pharmacovigilance and Labelling

4:50 PM — 6:00 PM

AI/Automation in ICSRs and Signals

4:50 PM — 6:00 PM

Aligning Stakeholders to Facilitate Access to Medicines for Children: From Product Development Through HTA Review

4:50 PM — 6:00 PM

Chat with Professionals – Career Twists and Turns

4:50 PM — 6:00 PM

Latin America Townhall

4:50 PM — 6:00 PM

Methodologies Session

4:50 PM — 6:00 PM

Overcoming Barriers to ATMPs Through Collaboration and Regulatory Reliance

4:50 PM — 6:00 PM

Türkiye Townhall: Latest Developments and Opportunities Towards Greater International Regulatory Convergence

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