Clinical trials in the EU

A large body of pharmaceutical legislation has been developed since Directive 65/65/EEC was introduced in the wake of the Thalidomide tragedy. The fundamental aim of the rules for medicinal products in the EU is to safeguard public health. However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the EU. Pharmaceutical Acquis is one of the most regulated areas of the Acquis Communautaireand gaining knowledge and understanding of it require significant time, efforts and resources, but it's a precondition for proper planning of your activities.

EU legislation is updated frequently following the changes of state-of-the-art science and technology and development of the society. The new Regulation on Clinical Trials is about to be implemented and includes requirements for conducting clinical trials.

Our pool of seminars is designed to save time and resources and enable you quick and simple understanding of EU rules and requirements on medicinal products.  

Clinical trials are a vital step in the development of new and safe medicines and in the improvement of the existing treatments. They are strictly regulated in the EU in order to ensure that rights, safety and well-being of trial subjects are protected and that results of clinical trials are robust and reliable.

This presentation will give you an overview on EU rules for performing clinical trials in the new Regulation on Clinical Trials, on the difference between clinical study and clinical trial (interventional, low-interventional, non-interventional), on the basic principles of performing the trials including protection of trial subject, the role of trial participants, documentation required and procedure to be followed for assessing clinical trials from scientific and ethical point of view and other important issues in line with GCP and legislative requirements.