Annex 13 Training
The conduct of clinical trials within the EU was significantly altered in October 2003, when European Commission Directive 91/356/EC was replaced by EU Directive 2003/94/EC, incorporating the requirements of Good Clinical Trials Directive 2001/20/EC.
Its impact was to bring investigational medicinal products (IMPs) used during clinical trials, under the legal umbrella of GMP principles and guidelines.
The introduction of the revision to Annex 13 of the EU GMP guide, placed more emphasis on operations. Annex 13 now provides guidance on the manufacture of IMPs, and provides detailed requirements about the manufacture, importation, release and supply of clinical trial materials in Europe.
The primary purpose of the directive and guidance is to ensure that the same standards are applied for manufacturing trial medicines (IMPs) as for manufacturing licensed medicines.
It is now crucial for companies and their employees to have a full understanding of their legal obligations and train their staff in GMP compliance.
Industrial Technology Systems Ltd (ITS) offers the following course to help employees and employers understand the revised requirements:
- Understanding Annex 13 Training, a one-day course can be undertaken on its own or as an addition to either the Introducing GMP or GMP Fast Track Fresher Programme. The course covers in detail the relevant regulatory requirements and developments, resource requirements, documentation, quality control and assurance, and a comparison with the FDA.
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