BUILDING STAKEHOLDER ENGAGEMENT THROUGH EAPs Download our guide on leveraging Early Access Programs to engage healthcare professionals, payers, and empower eligible patients with early access to innovative therapies. Gain valuable insights, contribute to real-world [...]
International Recognition Procedure From January 2024, the MHRA is adopting the International Recognition Procedure, reflecting a strategic pivot towards an independent and collaborative regulatory framework for swift and secure drug authorizations in the UK. Our [...]
Voluntary Scheme for Branded Medicines, Pricing, Access and Growth (VPAG) The new VPAG scheme is due to come in effect in January 2024 lasting for 5 years. The scheme, which has been agreed between the [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]