Occupational Health and Environmental Issues in Drug Development
Date: March 6, 2008
Time: 8:30 a.m. - 9:30 a.m.
Location: Pharmatek Laboratories, Inc.
Speaker: Allan W. Ader, Ph.D., D.A.B.T., Vice President and Principal Toxicologist, SafeBridge Consultants, Inc.
Presentation Summary
Two increasingly important aspects of drug development that impact speed to market are the increasing potency of the drug affecting how the drug is safely handled in R&D and manufacturing and the issue of pharmaceuticals in the environmental (PIE). This has resulted in the development of occupational health and environmental management systems to adequately protect workers handling the drug at the drug innovator and contract manufacturing or research organization, and conduct and interpretation of screening and regulatory – required environmental testing to meet manufacturing needs, as well as US and more stringent EMEA environmental risk assessment guidelines. This presentation will provide a systematic approach to incorporate these elements in project teams, offer technical guidance to EHS, engineering and product development staff, and review the approaches currently taken by the pharmaceutical and biotechnology industries on these important topics.
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About the Speaker
Dr. Allan Ader is co-founder and Principal Toxicologist for SafeBridge Consultants, Inc., the premier resource for high level safety, health and environmental support to the biotechnology and pharmaceutical industry, located in Mountain View, CA. Dr. Ader has extensive experience in developing occupational exposure limits and assessing compounds for toxicity and potency for compound categorization/banding and recommending handling practices and controls based on the toxicity/potency characteristics; assisting companies in testing of chemicals for their toxic effects and interpreting data from these tests; performing risk assessments including evaluating toxicological and exposure information to determine potential health and environmental effects of chemicals; and responding to crises caused by occupational health illnesses from chemicals by assessing and evaluating risks and communicating them to employees and management. Dr. Ader has over 25 years experience in the pharmaceutical and chemical industry including working for Syntex, Inc. in Palo Alto, CA and Olin Corporation, New Haven, CT. He received a Ph.D. in Industrial Health (Toxicology) from the University of Michigan and an M.S. in Industrial Hygiene from Temple University. He is a Diplomate of the American Board of Toxicology.
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