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Overview

Europe is facing challenging discussions related to affordability and patient access. Ongoing collaboration activities between national HTAs and between HTAs and Regulators hold some promise for better alignment of requirements that will allow more predictable assessment outcomes in Europe. Stakeholders have started to dialogue across disciplines and legislators are proposing new instruments to set up a sustainable system for EU collaboration on clinical value assessments. This meeting highlights the most recent advances on hot topics touching the interface between regulatory and patient access by providing perspectives from different stakeholders.

 

The meeting is a must-attend for anyone working on innovative solutions in clinical development, regulatory, access, outcomes research or health policy. It gives the opportunity to directly ask your burning questions on regulatory and patient access strategy topics to patients, scientists, policymakers, regulators, payers and HTA bodies.

 

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Featured topics

  • EU cooperation on HTA – present and future
  • Alignment of evidence requirements across EU and between regulators and HTA – are we ready/are we there?
  • Building synergies between regulators, HTA bodies and pricing authorities
  • Cross-functional multi-stakeholder dialogue to optimize market access and product affordability
  • Digital health solutions and their impact on drug development and access
  • Developments in other regions
  • Real World Evidence

Who should attend?

  • Professionals working in Regulatory Affairs and HTA/Market Access
  • Professionals involved in drug development, e.g. clinicians, epidemiologists and biostatisticians
  • Patient organisations
  • Biotech companies, drug developers including SMEs
  • Decision makers (Ministries of Health etc.)

Program Committee

  • Solange  Corriol-Rohou, DrMed, MD, PhD
    Solange Corriol-Rohou, DrMed, MD, PhD Senior Director, Global Regulatory Affairs & Policy, Europe
    AstraZeneca Global Medicines Development, France
  • Angelika  Joos, MPharm
    Angelika Joos, MPharm Executive Director, Global Regulatory Policy
    MSD (Europe) Inc., Belgium
  • Katarzyna  Kolasa, PhD
    Katarzyna Kolasa, PhD Professor of Health Economics, Head of Dept. of Health Economics and Health Mgmt
    Kozminski University, Poland
  • Mira  Pavlovic, DrMed, MS
    Mira Pavlovic, DrMed, MS Founder
    Medicines Development and Training (MDT) Services, France
  • Claudine  Sapède
    Claudine Sapède Global HTA and Payment Policy Lead
    F. Hoffmann-La Roche, Switzerland
  • Olga  Solomon
    Olga Solomon Head of Unit B5 - Medicines: Policy, Authorisation and Monitoring
    DG SANTE, European Commission, Belgium
  • Kristin  Svanqvist, MPharm
    Kristin Svanqvist, MPharm Governmental Affairs Manager
    Amgen, Norway
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