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
By sonia ziouani ammor In Kinesys News Tagged CTCL, Drug Development, Early Access, Early dialogue, MHRA, Oncology, Orphan Drug, Patient Access, PIM, Real-World Evidence, regulatory affairs
Kinesys Consulting last month secured another PIM designation, this time for a new oncology product, on behalf of a US partner. The product, successfully designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for the treatment of
Kinesys Consulting has secured its first PIM designation, for a novel oncology supportive care product, on behalf of a US partner. The product, designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for
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
