Chiu, Iris H.-Y. Regulatory convergence in EU securities regulation.
Alphen Aan Den Rijn : Wolters Kluwer ; Frederick, MD : Sold and distributed in North, Central and South America by Aspen Pub., 2008. Call number: KJE2247 .C45 2008
Publisher’s Description:
This outstanding book offers a new approach to the legal issues raised by the drive for convergence in securities regulation. The author offers a deeply informed and insightful examination of the implications for regulatory and policy design if regulatory convergence were to be rigorously implemented. After setting the development of the idea of regulatory convergence in historical context and defining what the term means, she goes on to investigate the web of legal issues surrounding the concept and its implementation, including the following:
• the benefits and drawbacks of the existing regulatory competition between Member States;
• ground-up (waiting for divergences to evolve through competitive processes) versus top-down mandatory convergence;
• regulation of intermediaries;
• the regulation of financial market transparency (visibility of pre-trade and post-trade information) and its effect on the business model of stock exchanges and markets;
• interpretations of market abuse in Member States;
• the rise of multilateral trading facilities (MTFs);
• theories on multi-speed clustering among like-minded Member States;
• the role of the Committee of European Securities Regulators (CESR); and
• the relationship of national penalties and enforcement convergence.
Arguing that the current patchwork of primary Directives and Commission Regulations is unlikely to secure convergent textual law, the author suggests that a rigorous pursuit of regulatory convergence should be based on adopting a systemic structure in designing regulatory features to achieve convergence. She proposes that regulatory convergence should capture four aspects of the law sources of law, interpretation and administration, supervision of compliance, through an overarching ‘cybernetic’ model which focuses on theand enforcement selection, transduction, and effectuation of norms, as well as on information and feedback processes and securing compliance with the norms.
Berry, Ira R. and Robert P. Martin, eds. The pharmaceutical regulatory process.
2nd ed. New York : Informa Healthcare, c2008. Call number: KF2036.D7 P47 2008
Publisher’s Description:
Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
