10 Tracks, One Shared Mission

Each track brings together regulators, industry, HTA bodies, and patients to explore a specific dimension of healthcare innovation and access.

• Artificial Intelligence & RWE

  Explore how AI and real-world data are accelerating drug development — from evidence generation and trial design to regulators' evolving perspective on data science.

• Clinical Trials Innovation

  Discover fit-for-purpose, patient- and site-centric trial designs and the risk-based regulatory ecosystem driving faster, smarter clinical trials across Europe.

• CMC & Quality

  See how manufacturers and regulators collaborate on chemistry, manufacturing and controls — advancing innovation without compromising the supply of medicines.

• Global Insights

  Hear regional health authorities and industry leaders share regulatory achievements and practical approaches to advancing patient access through global collaboration.

• Innovative Therapies, Precision Medicine & Diagnostics

  Follow how developers and regulators are adapting to cell & gene therapies, precision medicine, and complex diagnostics reshaping treatment for rare and chronic disease.

• Medical Devices & Combination Products

  See how the device and pharma sectors are collaborating on a regulatory environment built for digital innovation and converging combination products.

• Pharmacovigilance & Safety

  Gain insight into the global, patient-centric safety environment for medicines and devices, and the technologies strengthening how risk is monitored and managed.

• Regulatory Operations

  Track the digital transformation of regulatory operations — from the EU telematics strategy and IDMP/ePI to cloud systems and collaborative dossier review.

• Regulatory Strategy & EU Pharmaceutical Policy

  Explore the evolving European regulatory ecosystem — including the revised EU Pharmaceutical Legislation — and its strategic impact on global development.

• Value & Access

  Understand how value is defined across regions and stakeholders — regulators, industry, HTA, providers, patients — and how it translates into access.