Subject: and where relevant, the use of human or animal subjects and good clinical practice (including national legislation implementing Directive 2001/20/EC on good clinical practice, or comparable national legislation gen. Each of the parties will use all reasonable endeavours to obtain all regulatory and ethical licences, consents and approvals necessary to allow it to carry out the tasks allotted to it in Schedule 2.Each party shall ensure that its work on the Project complies fully with all applicable local, government and international laws, regulations and guidelines which are effective during the period of the Project, including those governing health and safety, data protection, and where relevant, the use of human or animal subjects and good clinical practice (including national legislation implementing Directive 2001/20/EC on good clinical practice, or comparable national legislation). In this regard, each Party shall maintain the full confidentiality of all samples and data relating to the use of human subjects, which is created or used in the course of the Project.
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приблизительно: а в тех случаях, когда это необходимо/уместно, использование людей или животных и (применение) добросовестной клинической практики (включая национальное законодательство, осуществляющее Directive 2001/20/EC о добросовестной клинической практике или сопоставимое национальное законодательство) |
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link 23.05.2012 18:08 |
where relevant - в надлежащих случаях не добросовестной, а надлежащей национальный закон, вводящий в действие (имплементирующий) Директиву и т.д. или сопоставимый/аналогичный национальный закон |
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