In a wide range of therapeutic areas, recent studies have highlighted the link between microbial imbalance (dysbiosis) and the development of certain diseases, such as allergies, cancer, asthma or gastro-intestinal diseases. Although the causality mechanisms are not...

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....

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 microbiome and its relationship to the maintenance of health is a topic that continues to gain more and more interest. Two terms that are often associated with this topic, and that relate to products marketed to influence the microbiome, are “prebiotic” and “...

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

A microbiome describes the collection of microbial life (microbiota) that inhabit a specific...

A medical writer is an essential part of any project team involved in developing a product to market and beyond. There is a need for high quality documents throughout this journey and an experienced medical writer is well qualified to help...

New requirements of the European regulations: demonstration of clinical evidence

To improve the health and safety of patients and users, Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices (IVDs) considerably reinforces certain essential...

Some of the current ‘hot topics’ discussed at the 46th European Medical Writers Association (EMWA) conference in Barcelona included the impact of the new EU regulations on medical devices (MDR) and in vitro diagnostic devices (IVDR), how the General Data...

It remains the mission of all stakeholders to get high-quality medicines to patients as time- and cost-efficiently as possible.

In preparation for Brexit, the 27 EU Member States, together with the European Medicines Agency (EMA), have reached a major milestone in the EMA Transition Plan.  The EMA has confirmed the reallocation of rapporteurs for the centrally authorised medicinal...

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