The importance of SMEs is nicely captured in a quote by Jean-Claude Juncker, President of the European Commission:

“We must not stifle innovation and competitiveness with too prescriptive and too detailed regulations,...

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...

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...

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.

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

By setting mandatory requirements, paediatric regulations implemented in the EU and the US have allowed the development of – and improved access to – high-quality drugs for the paediatric population. It is acknowledged that paediatric development remains a challenge...

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