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.
Parallel consultation, Scientific Advice & Early Dialogue – learnings from the past and shaping the future
- 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.)
- 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
Lucia D'Apote, DrSc, RAC • Director European Lead in Global Regulatory and R&D Policy
Claudine Sapède, PharmD • Director, Global HTA Policy
Novartis Pharma AG, Switzerland
Anja Schiel, PhD • Senior Adviser/Statistician, Unit for HTA and Reimbursement
Norwegian Medicines Agency (NoMA), Norway
Bakhuti Shengelia • Executive Director Global Policy and Healthcare Systems
Mira Pavlovic, DrMed, MD, MS • HTA Expert /Director/HTA Professor
NDA Advisory Services, Medicines Development and Training (MDT) Services, France
Martina Laus • Group Quality External Engagement
Novartis International AG, Switzerland