Webinar on Environmental Assessment of New Human Drugs – Regulatory Requirements and Lessons Learned

News & Events

September 19, 2017

Join Gradient for a Free Webinar on Thursday, October 12, 2017, from 1:00-2:00 PM ET

Market approval of new human drugs in the US and the EU often requires an assessment of potential environmental impacts associated with patient use. Environmental assessments can be costly, lengthy, and technically challenging, and need to be tailored for each drug and market. As such, early consideration of environmental assessment obligations as part of new drug approval is important. This webinar will provide an overview of existing regulatory requirements, highlight key differences between US and EU regulations, and discuss upcoming regulatory developments. Using several case studies, including for endocrine-active and antibiotic drugs, we will illustrate technical challenges and successful approaches for conducting EU and US environmental assessments.

Register here:   “Environmental Assessment of New Human Drugs – Regulatory Requirements and Lessons Learned”
Thursday, October 12, 2017, from 1:00-2:00 PM ET

Regulatory Requirements
Tamara Lunsman, Ph.D.
, is a senior environmental toxicologist at Gradient with experience in evaluating environmental risks and interpreting ecotoxicity data. She will discuss existing environmental assessment regulations and key differences between US and EU regulatory requirements that need to be considered when planning an environmental assessment.

Lessons Learned
Tim Verslycke, Ph.D.
, is a principal at Gradient with over 15 years of combined academic and consulting experience in the field of pharmaceuticals in the environment. He will discuss several drug environmental assessments that Gradient has worked on over the years to highlight key challenges and describe successful approaches.

Topics Covered in this Webinar:

1. Successful environmental testing and evaluation strategies for new human drugs
2. Key differences between EU and US environmental assessment requirements
3. Whether a new human drug may solicit increased regulatory scrutiny and require a tailored assessment

Gradient is an environmental and risk science consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products.