Scientific-Technical Backgrounds for Biotechnology Regulations

Based on lectures given during the Eurocourse held in Ispra, Italy 1991. Examines the need for regulatory frameworks for biotechnology.

Part 1 Genetic Engineering - Research Activities: Genetic Engineering - an Overview; V. Sgaramella. Gene Transfer in Nature - Its Mechanisms and Limitations; J. Davies. The Blood Cioagulation Cascade - the Proteins and Their Biosynthesis by Recombinant DNA; E.W. Davie, B. Carter. Development of Genetically-Engineered Microorganisms and Testing of Their Fate and Activity in Microcosms; D.F. Dwyer. Research Activities of the European Communities in Biosafety; I. Economidis. Part 2 Genetic Engineering - Industrial Applications: Safety in Biotechnology and the Large in vitro Propagation of Animal Cells for Derived or Recombinant Products; M.J. Comer, D.V. Hoerschelmann, U. Behrendt, J. Wahl, K.H. Sellinger. Industrial Fermentations with Genetically Modified Microorganisms; J.L. Mahler. The Production of Human Insulin; J. Thorley. Industrial Production of Vaccines and Therapeutic Molecules by DNA Technology; G.C. Viscomi. Part 3 Genetic Engineering - Agricultural Applications: Basics of Plant Gene Transformation; G. Van den Eede. Field Releases of Transgenic Plants in Practice; W. De Greef. The Widespread Use of Transgenic Crops - Opportunities and Perspectives; P.J. Dale. Part 4 Regulatory Issues: Regulation and Bio-Industry Development; R. Ugo, V. Lungagnani. Public Reaction to Biotechnology and to the Release of GMOs in Europe; F. Terragni. Uncertainty and Regulation; S.O. Funtowicz, J.R. Ravetz. Part 5 Regulatory Framework: Regulation of Medicinal Products Derived from Biotechnology in the European Community; P. Brunko. General Principles of the Council Directive on the Protection of Workers from the Risks Related to Exposure to Biological Agents at Work; H. Martin. Patenting Biotechnological Inventions; C. Gugerell. The Deliberate Release into the Environment of Genetically Modified Organisms, GMOs; J. Kioussi. The Contained Use of Genetically Modified Microorganisms; F. Campagnari. The EPA Perspective on Biotechnology; L. Zeph.