Europital – help is at hand!

Compassionate Use – help is at hand! When all approved therapies have been exhausted and no satisfactory or alternative therapy options remain for a patient with a serious or immediately life-threatening medical condition, the patient’s last path available could be to use an unapproved treatment. Receiving this treatment without participating in a specific clinical trial […]

 

 

The 5W1H Approach toWriting a Clinical Study Protocol An age-old writing methodology based upon the thoughts of Aristotle, the Ancient Greek philosopher and scientist who was Plato´s student and who later taught Alexander the Great, is as applicable to today´s technologically advanced biopharmaceutical research sector as it has been throughout history. This 5W1H formula constitutes […]

 

 

Europital – Building Your CTD Pyramid

The CTD Pyramid Around the turn of the century, the Common Technical Document (CTD) became the standard reporting format that needs to be followed when submitting data on the quality, safety, and efficacy of a treatment for all new drug applications (NDAs). The CTD is a mandatory reporting format in the EU and Japan and […]

 

 

Finding the art in medical device compliance Notified Bodies need to evaluate the medical device´s operating risk-benefit ratio and various other factors and, in order for them to do so, the MDR 2017/745 and the MEDDEV 2.7.1 (Rev 4) states that they require a description of the “state of the art” in the medical field associated with […]

 

 

Crafting an Effective Clinical Evaluation Plan The MEDDEV 2.7.1 (Rev 4) introduced the requirement of a Clinical Evaluation Plan (CEP) and the Medical Device Regulation (MDR 2017/745) gave more details on what this new and critical document should contain (particularly in Annex XIV, Part A). The scope of the full clinical evaluation is stated in the CEP and includes, at the very […]