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Overview

Join all relevant V&A and Regulatory stakeholders in seeking solutions to the challenges of aligning Regulatory and Reimbursement strategies in Europe. In this quest for fast, effective and pragmatic solutions for getting better medicines to patients in need, the agenda will also discuss implications for Global development programmes, where additional complexities lie.

Featured topics

Parallel consultation, Scientific Advice & Early Dialogue – learnings from the past and shaping the future

Patient role/involvement

    • How and when in regulatory and HT assessment process patients could be more effectively engaged?
    • The role of patients in shaping outcome measurements for regulatory and reimbursement purposes

Uncertainty of evidence - feasibility of delivering an a data package acceptable for both regulators and reimbursement authorities

    • Choice of comparator
    • Surrogate/intermediate endpoints and extrapolating the results
    • Use and acceptability of innovative clinical trial designs (adaptive trials, master protocols, use of historical controls)

Post-licensing evidence generation

Suitability of current regulatory & value frameworks for new technology based curative therapies(e.g. cell and gene) in the pipeline

Regulatory vs access views – internal alignment within industry functions?

Unmet medical need & evidentiary standards

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.)
  • Learning objectives

  • Through candid and well informed discussion help all involved stakeholders find better ways to improve communication in the regulatory-reimbursement ecosystem
  • Identify the limitations in how evidence is used across the entire regulatory-reimbursement and their implications for the patients answer the question of what isn’t working perfectly
  • Come up with pragmatic solutions for closing existing evidence gap and their policy implications (“what could we do” and “how we should do”).
    • Program Committee

      • Lucia  D'Apote
        Lucia D'Apote Director, European Lead Global Regulatory and R&D Policy
        AMGEN, United Kingdom
      • Mira  Pavlovic, DrMed, MS
        Mira Pavlovic, DrMed, MS HTA Expert / Managing Director
        NDA Advisory Services, Medicines Development and Training (MDT) Services, France
      • Claudine  Sapède, PharmD
        Claudine Sapède, PharmD Global HTA and Payment Policy Lead
        F. Hoffmann-La Roche, Switzerland
      • Anja  Schiel, PhD
        Anja Schiel, PhD Senior Adviser/Statistician, Unit for HTA and Reimbursement
        Norwegian Medicines Agency (NoMA), Norway
      • Bakhuti  Shengelia
        Bakhuti Shengelia Executive Director Global Policy and Healthcare Systems
        Novartis, Switzerland
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