Science Events in Boston
Stay up-to-date with all of the life science events taking place in the Greater Boston area with the Science in Boston events calendar! From academia to industry and biotech to pharma, our events calendar is your complete source for life science conferences, symposiums, networking, and workshops in Boston. We even cover science pub nights and science fundraisers!
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Overview of the Anticipated Environmental Risk Assessment Guideline Revisions, with Selected Case Studies and Perspectives from Industry Experts
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
