Pharmaceutical Regulatory Affairs and IPR

Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global

commercialization strategies. This session outlines various circumstances to be considered for the implementation of EAPs named patient programs, EU regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation.