See the attachments below for a series of white papers regarding global market access for specialty pharmaceutical, medical device and in vitro diagnostic products
The following article on biosimilars regulation was recently published by Stephen Amato in Bio-IT World:
Biosimilars: Not So Similar to FDA Generic Drug Approvals
The following article on the convergence of market access and regulatory variables was recently published by Stephen Amato in Pharmaceutical Compliance Monitor:
Optimizing the 3 P’s – Product, Pricing and Patient Outcomes – How Do We Get There?