Events
65 - International Workshop <quote>Gene therapy early phase clinical trials regulations, safety issues and suitability of preclinical animal models</quote>. Istituto Superiore di Sanità, Rome, February 24-25, 2000. Abstract book. Edited by Maria Cristina Galli 2000, iii, 26 p.
International Workshop Gene therapy early phase clinical trials: regulations, safety issues and suitability of preclinical animal models
. Istituto Superiore di Sanità, Rome, February 24-25, 2000. Abstract book.
Edited by Maria Cristina Galli
2000, iii, 26 p. ISTISAN Congressi 65
Gene therapy studies have rapidly evolved in the recent years from the laboratory to the bedside. Committees for evaluating the clinical use and guidelines describing the requirements for gene therapy products have been set up in many countries to face the need for regulation in a field presenting with unique features. The goal of the International Workshop is to convey to researchers in gene therapy field an updated picture of the following issues: i) regulatory requirements and procedures needed to start clinical trials in European countries; ii) designing of safe vectors for clinical use and iii) suitable animal models useful for obtaining preclinical safety and efficacy data for early phase clinical trials.
Key words: Clinical trials, Efficacy, Gene therapy, Quality, Safety
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Publications ISTISAN Congressi