Developmental and Reproductive Toxicology
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Who Should Attend
This course is designed to enhance the job performance of decision-makers responsible for product development and/or stewardship in the pharmaceutical, agrochemical, petrochemical, and biotechnology industries, as well as those in national government. The intended audience includes department heads, directors of toxicology/safety assessment, project managers, study directors, senior research investigators, and regulatory officials. Other persons who may find value in the subject matter include technologists involved with laboratory operations, legal counsel and public communications specialists.
Description
This course will survey the scientific basis of and regulatory requirements for developmental and reproductive safety evaluations. Study designs, aspects of study conduct, data interpretation, and selected techniques for screening and testing pharmaceutical drugs, industrial and agricultural chemicals, and biotechnical products for developmental and reproductive toxicity will be described. Regulatory requirements for the United States, including those of the FDA and the EPA, as well as international requirements, concentrating on the new International Conference on Harmonization (ICH) guidelines, will be reviewed. Principles underlying the science of developmental and reproductive toxicity, including basic embryology and critical periods of sensitivity for developmental insults, will be discussed. The major endpoints in developmental and reproductive toxicity studies will be explained. The types and frequencies of spontaneous external, soft tissue, and skeletal malformations and variations will be presented. Interpretation of results, including the impact of the relationship of maternal or paternal toxicity to observations in the offspring will be addressed. Quality assurance issues relevant to these studies will be discussed. The areas of focus, depth of detail, and extent of practical considerations relative to the above items will be based upon enrollment.