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Occupational Health And Environmental Issues In Drug Development Pharmatek Laboratories, Inc.
March 6, 2008 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. Allan W. Ader, Ph.D., D.A.B.T. 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. 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. About: Pharmatek Laboratories, Inc. is a premier pharmaceutical chemistry development organization supporting the pharmaceutical and biotechnology industries. Pharmatek focuses on bringing client compounds from discovery to the clinic with services that include compound selection, analytical development, preformulation testing, formulation development, GMP manufacturing, ICH stability storage and testing, and cytotoxic & high-potency development. PTEK U is a local seminar series focused on fostering education in and knowledge of drug development and pharmaceutical technology. Seminars provide a forum for scientific exchange regarding topics that affect the biotech and pharma industries. Speakers are experts within the broad scope of pharmaceutical sciences. Topics cover drug development issues, such as analytical chemistry, preclinical drug development, formulation development, GMP manufacturing, toxicology, pK/ADME, drug safety, design of clinical trials, regulatory affairs, and drug delivery and pharmaceutical technology. Participation is open to all interested in pharmaceutical research and attendance is free of charge. Information & RSVP
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