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Swissôtel Le Plaza

Oct 24, 2019 9:00 AM - Oct 25, 2019 5:30 PM

Messeplatz 25, 4005 Basel, Switzerland

Value, Access & Regulatory Evidence Workshop

Acknowledging the different perspectives and finding the pragmatic way forward


This workshop brings together 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, most effective and pragmatic solutions for accelerating the availability of medicines to patients in need, the agenda will use case studies and panel discussions. The event will cover the state of play experience from REA pilots and potential development post-2020 surrounding joint clinical assessments (JCAs). We will also discuss current challenges and gaps in PLEG and other implications for Global development programmes, where additional complexities lie.

The workshop builds on the EMA-EUnetHTA work programmes and have key opinion leaders from both sides involved.

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”).
  • Trying to find solutions for patients to get access to medicines they need

Program Committee

  • Lucia  D'Apote, DrSc, RAC
    Lucia D'Apote, DrSc, RAC Executive Director Global Regulatory and R&D Policy (ELMAC and JAPAC)
    Amgen, Switzerland
  • Claudine  Sapède, PharmD
    Claudine Sapède, PharmD Director, Global HTA Policy
  • Anja  Schiel, PhD
    Anja Schiel, PhD Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA
    Norwegian Medicines Agency (NoMA), Norway
  • Bakhuti  Shengelia
    Bakhuti Shengelia Executive Director Global Policy and Healthcare Systems
    Novartis, Switzerland
  • Mira  Pavlovic, DrMed, MD, MS
    Mira Pavlovic, DrMed, MD, MS HTA Expert /Director/HTA Professor
    NDA Advisory Services, Medicines Development and Training (MDT) Services, France
  • Martina  Laus
    Martina Laus Group Quality External Engagement
    Novartis International AG, Switzerland

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