Navigating the Future of EU Joint Health Technology Assessments With the Health Technology Assessment (HTA) landscape undergoing transformation in January 2025, it's essential to prepare your pipeline for what lies ahead. Our Market Access team [...]
COLLECTING REAL WORLD DATA IN EAPs We recognize the tremendous value Real World Data (RWD) can offer in the pre-approval space and work closely with our Sponsors to understand the opportunity for RWD collection in [...]
Product Uptake By Country PA-NPPs adhere to strict legislation regarding the supply of unlicensed medicines on an unsolicited request basis. As such, there are many factors that determine the level of uptake in a PA-NPP, [...]
EAP VERSUS OLE Both an Open Label Extension (OLE) and an Expanded Access Program (EAP) can be used to provide continued treatment access after phase 3 clinical trials have ended.To help companies understand both programs [...]
SPONSOR CONSIDERATIONS FOR EAPs If your company is developing a drug that fulfils an unmet clinical need, you may have already started receiving patient enquiries about expanded access.We have put together this downloadable resource that [...]
EXPANDED ACCESS POLICY TEMPLATES If your company is developing a drug that fulfils an unmet clinical need, you may need an Expanded Access Policy on your website.We have provided three templates, one for each of [...]
