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Our pool of seminars is designed to save time and resources, and enable to get a quick and simple understanding of EU rules and requirements on medicinal products.
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.
Broader perspective of regulating medicines in the EU helps in putting regulatory puzzles on the right place. It requires the basic knowledge on the principles of regulating medicines in the EU and on the main legislative acts that are ruling the Pharmaceutical Sector at the EU level.
This presentation is about aims and basic principles of regulating medicinal products in the EU or in other words about the EU Pharmaceutical Acquis, its scope, legally binding and non-binding documents as well as areas that are left to be regulated at national level. We'll present you its early starts that will help you to understand why the rules are so strict and extensive. It's easier to study details if the big picture is clear, if you know where to find the necessary documents, understand their interconnections and the development trends.
Performing activities linked to medicinal products in the EU require basic knowledge on how the area is regulated. This seminar will help you in a simple and comprehensive way to get a quick review of the principles applied, enable better understanding and answering company tasks, obligations and options.
