There is ample anecdotal evidence suggesting that firms can experience serious losses from social, ecological or ethical problems that exist in their supply chains. So far, however, research on supply chain risk management has largely neglected these sustainability issues. Most importantly, little is known about how sustainability issues manifest themselves as risks and how they create losses for focal firms. Without an in-depth understanding of this materialization process, conceptualizations of sustainability risks will remain vague and effective management frameworks cannot be developed. We address this important research gap by means of a transdisciplinary approach and provide a concise description of how sustainability issues in supply chains materialize as risks for focal firms. Building on this mechanism and drawing on stakeholder theory, we develop a conceptualization of sustainability risks which lays the basis for future investigations in this respective field. In addition, we devise a viable management concept for sustainability-related supply chain risks. The proposed concept can help firms to mitigate sustainability issues in global supply chains, thus making them less vulnerable to losses resulting from these risks. Its application will also foster sustainability standards within supply chains.

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Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 aims to harmonise national regulations governing clinical trials of medicinal products for human use in the European Union. This aim is to be achieved by harmonising the legal regulations and administrative provisions in force in the Member States, especially with respect to the requirements for starting and conducting clinical trials, taking into account international ethical and scientific standards (Good Clinical Practice). The goal is to further improve the protection of participants in clinical trials and to promote clinical research within the European Union. In Germany, the necessary transposition into the national Drug Law has taken place in the form of the 12th Law Amending the Drug Law of 30 July 2004 as well as complementary implementation provisions. The amendments to the German Drug Law affect in particular the official authorisation procedure, the involvement of ethics committees as well as the conduct of clinical trials on minors. The Directive's requirements have been transposed into German law while maintaining the high level of protection for the participants in clinical trials which had already existed in German legislation.

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