Seminar: Environmental Risk Assessment Guideline Revisions and Perspectives

July 24, 2019

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