Seminar: Environmental Risk Assessment Guideline Revisions and Perspectives

News & Events

Join us at MassBio in Boston for an overview of the anticipated Environmental Risk Assessment guideline revisions, with selected case studies and perspectives from experts.

Event Date:  Monday, August 5, 2019

 

Location:  Massachusetts Biotechnology Council, 300 Technology Square, Eighth Floor, Cambridge, MA 02139

 

Presentation Topics:

Notable Changes to the Existing European Medicines Agency Guideline for ERA: How Revisions Could Affect Testing and Environmental Risk Assessment of Human Drugs
Speaker: Dr. Erick Nfon, Smithers Viscient

  • Introduction of a decision tree that clarifies when ERA studies are required
  • New guidance for the estimation of exposure to human pharmaceuticals via the food chain (secondary poisoning)
  • Revision to the tiered approach to laboratory testing
  • Introduction of tailored risk assessments for active substances with specific modes of action, e.g. antimicrobials and Endocrine Active Substances

Environmental Assessment of New Human Drugs: Case studies and Lessons Learned
Speaker: Dr. Tim Verslycke, Gradient

  • Changes in drug R&D are increasingly requiring a tailored environmental assessment approach
  • Real case studies to illustrate environmental assessment strategies for “nonclassical” drugs with unique physical-chemical properties, unique modalities, etc.
  • Lessons learned and perspectives on current regulatory framework for environmental assessment

Industry Perspective on New EMA Guidelines
Speaker: Dr. Jessica Vestel, Merck

  • Key changes to new guidance
  • Predicted impacts to industry

Seating at this free seminar is limited. Please RSVP by July 29, 2019

Register here