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...

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...

In draft guidelines prepared by the President of the European Council, and published on 7 March 2018, the European Council has downplayed the likelihood of the United Kingdom staying in the regional regulatory network after Brexit. Previously, British Prime Minister...

We are on the home-straight to Brexit!  Just one year (30th March 2019), to the official date in which the United Kingdom will no longer be a member of the European Union. 
The 2nd Industry Stakeholder meeting on Brexit...

The current trading dynamic between the UK and EU, in the pharmaceutical sector, represents one of most integrated relationships of all the industry sectors.  Not only in terms of product trade, but also in terms of R&D,  legislative and regulatory...