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Europe's 2nd Operationalizing Early Access Programmes Summit, October 2023


HL Pharma attended the recent Operationalizing Early Access Programmes Summit.  The European event provided an invaluable platform for addressing critical issues within the pharmaceutical industry. 



The recent Operationalizing Early Access Programmes Summit in Europe, provided an invaluable platform for addressing critical issues within the pharmaceutical industry, and focused on topics such as drug supply, regulatory harmonization, and the collection of real-world evidence. 

The summit brought together key figures, including Heads of Managed Early Access, Expanded Access, Pre-Approval Access, Named Patient, Compassionate Use, Medical Affairs, Medical Operations, and Clinical Operations and Supply, representing large pharmaceutical companies, biotech’s, and patient advocates.

The event fostered a collaborative environment whereby discussions took place around optimising strategies to effectively operationalize access programs.  With speakers at the summit sharing the common goal of enhancing patient access, presenting practical solutions to operational challenges.

The event facilitated invaluable interactions with smaller biotech companies, and provided a forum to be able to delve into management and improvement of compassionate supply systems.

Topics were explored encompassing temperature-controlled delivery to warehouse facilities, customs clearances, permits, supply permissions, dispensing, pharmacovigilance assistance, and ensuring visibility of the supply chain to patients.

Moreover, the summit underscored the significance of information feedback from prescribers and patients in addressing industry challenges.

The exchange of insights emphasised the importance of being apart of events of this type, in order to continue to build on processes and better maximise outcomes, as well highlighting the importance of feedback in the ongoing management of product licenses and investigation into potential alternative uses.  OEAP-063OEAP-240