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.
- 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.)
Angelika Joos, MPharm • Executive Director, Global Regulatory Policy
Merck Sharp & Dohme (Europe) Inc., Belgium
Mira Pavlovic, DrMed, MS • HTA Expert / Managing Director
NDA Advisory Services, Medicines Development and Training (MDT) Services, France
Claudine Sapède, PharmD • Director, Global HTA Policy
Novartis Pharma AG, Switzerland
Olga Solomon • Head of Unit B5 - Medicines: Policy, Authorisation and Monitoring
DG SANTE, European Commission, Belgium
Kristin Svanqvist, MPharm • Governmental Affairs Manager
Solange Corriol-Rohou, DrMed, MD, PhD • Senior Director, Global Regulatory Affairs & Policy, Europe
Astrazeneca Research & Development, France
Katarzyna Kolasa, PhD • Professor of Health Economics, Head of Dept. of Health Economics and Health Mgmt
Kozminski University, Poland