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Our pool of seminars is designed to save time and resources, and to 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.
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 compliance with internationally recognised ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials – GCP.
Clinical data necessary to define and confirm product's safety and efficacy must be obtained following strict ethical, scientific and regulatory criteria and the agreed standards set in Good clinical practice.
This presentation gives you a brief overview of the general and regulatory aspects of mandatory GCP in the EU (ICH regions), its main principles and documents to be generated and followed as well as specific issues to be taken into consideration when conducting an GCP compliant trial. Compliance with GCP provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are accurate and credible. Understanding the requirements, particularly in the light of new Regulation on clinical trials facilitates the decision to perform ICH-GMP compliant trial.
