Sample Regulatory Assessment for Treatment Access Program The WEP Regulatory team has created this resource to highlight the heterogenous regulatory landscape across treatment access programs including Expanded Access Programs (EAPs), Compassionate Use Programs, and [...]
Sponsor Considerations for Post-Trial Access If you are coming to the end of your clinical trial, you may have started thinking about if and how to provide post-trial access for patients. To help Sponsors, [...]
Harnessing Real-World Data for Market Access Success Download our free resource exploring the value of Real World Data (RWD). Collecting RWD can help inform your market access strategy and prepare you for successful product launch. [...]
Step-by-step EAP Management process The infographic outlines the processes involved in running an end-to-end Expanded Access Program (EAP). Companies need to understand all elements involved, to ensure efficient and consistent medicine supply to patients [...]
NAVIGATING ASSET TRANSITIONS THAT INCLUDE EAPs A common challenge for many companies during asset movements is the transition of Expanded Access Programs (EAPs). EAPs are often overlooked in the initial agreements and transition plans, leading [...]
Managing patient requests for Your investigational medicines Expanded Access Programs (EAPs) allow companies to provide their investigational medicines to patients outside of the clinical trial setting, to fulfil unmet clinical needs.WEP has put together a [...]
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 [...]
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 [...]