The Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, assessors and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol....

With the objective of harmonising pharmaceutical regulatory practices and legislation with Europe, the Swiss Medicines Agency (Swissmedic) recently conducted an in-depth review of the primary legislation governing the authorisation and lifecycle management of...

An informative session at this year’s DIA meeting gave an overview of the European Commission’s proposal for mandatory centralization of HTAs, together with an update on the initiative which provides for joint HTA and pricing negotiations between the five Beneluxa...

The “Condition” is typically a recognised distinct disease or syndrome that is the subject of a paediatric investigation plan (PIP) and/or waiver application required for most new, and some authorised, medicinal products in the EU. Its scope defines the disease(s)...

DIA Europe 2019 was held this year in Vienna, Austria. Speakers included national regulators, together with representatives from health technology assessment (HTA) bodies, patient advocacy groups, and other critical stakeholders. Presentations covered the entire...

Antimicrobial resistance (AMR) is the ability developed by bacteria, viruses, parasites or fungi to fight and block the effect of antimicrobials including antibiotics, antivirals and antiparasitics that were developed to kill or control their growth. AMR is a global...

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

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