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.
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?
Lucia D'Apote • Director, European Lead Global Regulatory and R&D Policy
AMGEN, United Kingdom
Mira Pavlovic, DrMed, MS • HTA Expert / Managing Director
NDA Advisory Services, Medicines Development and Training (MDT) Services, France
Claudine Sapède, PharmD • Global HTA and Payment Policy Lead
F. Hoffmann-La Roche, 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