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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 ICH-GCP as well as requirements for proper surveillance.
GCP compliance 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. GCP inspections/audits are aimed to determine whether the clinical trials are compliant with the clinical trial approval, the trial protocol and the applicable legislation and guidance.
This presentation gives you a brief overview of the types of GCP inspections/audits and their conduct, key documents that are to be taken into consideration, and addresses misconducts and frauds in clinical trials.
