PHP57 - EUROPEAN CONDITIONAL MARKETING AUTHORIZATION – DOES EARLY MARKETING AUTHORIZATION TRANSLATE INTO EARLY REIMBURSEMENT AND PATIENT ACCESS?

An antibiotic’s journey from marketing authorization to use, Norway

Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective antibiotic stewardship policies and an associated low prevalence of antibiotic-resistant bacterial...

Authorization and Access Control

Once we have received a claim of identity and established whether that claim is valid, as we discussed in Chapter 2, we move on to what the party is allowed to do and whether we will allow or deny them access to our resources. We can achieve this with two main concepts: authorization and access control. Authorization allows us to specify where the party should be allowed or denied access, and a...

Access Rights Authorization

The availability of 64-bit processors enables operating systems the use of the sharedaddress space (SAS) paradigm where all processes execute in the same address space.This is in contrast to most existing operating systems that use the private addressspace (PAS) paradigm where each process views the entire space as dedicated to itself.The PAS paradigm yields high overhead for in...

From Centralized Marketing Authorization to National Reimbursement - A Challenging Journey for New Medical Products with Placebo Controlled Trials.

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency

BACKGROUND Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug Administration (FDA) have published guidance documents addressing the potentials and limitations of...