An inter-regulatory and stakeholder workshop on combination products, organised by TOPRA and RAPS, was held in Brussels in November 2018. Reported by Stéphanie Francard, Senior Regulatory  Scientist, VCLS, and Chris Wilson, Senior Director, Regulatory...

The introduction of a new medicinal product to the US market follows a complex process that may extend many years from the initial discovery through to the US Food and Drug Administration (FDA) approval and market launch. There are many factors during the product...

Considerations on the development of pharmaceuticals and foods designed to favourably impact the human microbiome – health claims, legislation and development.

Introduction

A microbiome describes the collection of microbial life (...

Value Proposition

The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where new value can be created and how the company can best capture that value.

Health Economics and Outcomes Research (HEOR)

Health Economics and Outcomes Research (HEOR) is the most common label given to the function within pharmaceutical and life science companies with the responsibility for generating evidence of value of new interventions for reimbursement agencies

There is some variation in the eligibility criteria and features of breakthrough therapy designation (BTD), regenerative medicine advanced therapy (RMAT) designation, and the PRIority MEdicines (PRIME) scheme, as will be explained in this review. The expectations...

We will review challenges in translation required to develop the ATMPs pharmaceutical product (cell and gene therapy products) from nonclinical to the clinical stage, as well as the challenges related to the determination of proof-of-concept, how to choose clinical...

 

The UK will withdraw from the EU on 29 March 2019. By 1 August 2018, no agreement had been reached on a transitional arrangement to soft en the impact of Brexit. The European Commission and the European Medicines Agency (EMA) have taken a...

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

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