Best Practices in Oncology Joint Clinical Assessment (JCA) Submissions Under the EU HTA Regulation
The first oncology JCA reports show that this new EU assessment process is anything but routine. Here’s what sponsors can learn from early submissions, and how to prepare for what’s ahead.
Breaking Barriers in Immuno-Oncology: Mechanistic Insights into Immune Checkpoint Inhibitor Resistance and Implications for Health Economics and Outcomes Research and Value Assessment
Immune checkpoint inhibitors deliver transformative outcomes, yet real‑world durability is often limited by primary and acquired resistance. This article explores the biological foundations of ICI resistance and outlines how integrating these insights into HEOR models can improve value assessment and real‑world decision‑making.
The Essential Role of Real World Evidence Combating COVID-19
Are you prepared for potential accelerated approval requirements?
ISPE’s Position on Real World Evidence (RWE)
Read more about the February 2020 position on RWE from ISPE.
Lack of Label Alignment & Patient Safety Implications
Read the full article from UBC’s pharmacovigilance team in Drugs Real World Outcomes.
Risk Management Plan Development & Implementation
Listen to the full podcast from UBC with PharmaVOICE here.
Top Trends in Oncology Patient Support
Find out what access and adherence challenges patients will need to overcome in the evolving oncology market.
Are You Ready For Sentinel? | New RWE Safety Initiative
With continued investment in the RWE space, find out how to meet the needs of regulators, payers, and prescribers.
Immunogenicity: Meeting the Safety Reporting Requirements
Discover why it is imperative to assess the potential of therapeutic proteins throughout the product lifecycle.
