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
Adaptive Pathways and Patient AccessAn issue panel entitled Adaptive Pathways and Patient Access: Pushing Payer Boundaries or Facilitating New Payment Models? was held and moderated by Jacoline Bouvy, Scientific Adviser, National Institute for Health and Care Excellence (NICE), London, UK. Jacoline
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
A handy guide to the practicalities of working in Regulatory Affairs in a biotechnology company. To Download the Handbook - Click here