Since 2014, there has been a welcome recognition within Europe of the need for improved regulatory mechanisms whereby medicines being developed to target serious or life-threatening diseases that represent an unmet clinical need can be made available to patients at
By sonia ziouani ammor In Events Tagged Adaptive Pathways, Clinical Trials, Drug Development, Early Access, Early dialogue, EMA, Europe, MHRA, Patient Access, PIM, PRIME, regulatory affairs
With the increasing acknowledgement of the need to develop an overarching scheme to enhance support for sponsors developing medicines, tackling unmet medical needs to ensure timely access to beneficial therapies, the EMA launched the PRIME scheme in March 2016. This
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) opened last Monday its 19th Annual European Congress in Vienna, Austria with a plenary session entitled What Synergies Could Be Created Between Regulatory and Health Technology Assessments?The plenary discussion was moderated by
