Educational Webinars

Assessing the Environmental Risk of Pharmaceuticals following Patient Use

June 17, 2020

Time: 11:00 AM ET

Hosted by American College of Toxicology

Supported by the Society of Toxicologic Pathology

Speaker: Dr. Lisa Constantine, Pfizer

After completing a BS in Chemistry at Niagara University, Niagara Falls, New York, Lisa began her career at Olin's Industrial Hygiene Lab in New Haven, Connecticut developing analytical methods, designing and conducting experiments to evaluate airborne exposures to support a safe manufacturing environment for workers. While at Olin, Lisa obtained an MBA from the University of New Haven, New Haven, Connecticut and earned her certification in industrial hygiene from the American Board of Industrial Hygiene. Lisa joined Pfizer in 1998, supporting worker safety and worldwide chemical registration and ultimately transitioning to the area of environmental risk assessment. Over the last 15 years, Lisa has collaborated with industry, government, and academic partners on PIE related research, publications and presentations, and is active in SETAC, ECETOC, and EFPIA activities.

Abstract:

Human pharmaceuticals are routinely detected in wastewater, surface water, and aquatic organisms. Significant advances in instrumentation, analytical techniques, and methodologies have enhanced the ability to detect pharmaceuticals in the environment at lower and lower concentrations. Following manufacturing and patient use, pharmaceutical residues including active ingredients, human metabolites and/or transformation products present in domestic and industrial wastewater treatment effluents are released into the aquatic environment.

The presence of pharmaceuticals in the environment (PIE) and the need to understand associated risks has become the focus of numerous research initiatives among industry, academia, and governmental agencies worldwide. Regulatory requirements to provide an environmental risk assessment (ERA) associated with patient use for drug registration have been in place within the US and EU for 14+ years, with legislation in other geographical regions expected in coming years.

The focus of this presentation is to provide a greater understanding of the potential environmental risk of pharmaceuticals following patient use. A review of the ERA regulatory requirements for drug approval, the knowledge acquired over the last 14+ years and key areas of ongoing research supported by industry, academia, and governmental agencies worldwide will be discussed.

There is no fee but advance registration is required.