Biologics Safety Preclinical, Clinical and Regulatory

Author: Hennig R.

Source: Expert Opinion on Drug Safety, Volume 2, Number 6, 1 November 2003 , pp. 609-611(3)

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Abstract:

Biologicals offer particular challenges for all concerned, whether they be scientific researchers, profit-oriented companies (including not yet profit-producing start-ups), public health-focused regulators, physicians, or, most importantly, patients. One of the most important of these challenges is safety. Hence, this conference was organised by Vision in Business (the trading name of Analysis and Networking Ltd) to provide practical solutions and advice for comprehensive, effective safety testing. It provided a wide spectrum of presentations, ranging from the usefulness of animal models for biologicals safety predictions, to an FDA perspective on implications of its recent restructuring, to a real-life case study on erythropoietin and pure red cell anaemia. For anyone seriously interested in the safety of biologicals, this was a very good opportunity to gain an overview of all major aspects of biologicals safety, broaden existing expertise and to network with those concerned with these issues.

Keywords: biologicals; immunogenicity; regulators and safety; safety; safety testing

Document Type: Meeting report

Publication date: 2003-11-01

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