JUL 30, 2019 06:00 AM PDT

Overview of the new ERA Guidelines: Changes and Revisions

SPONSORED BY: Smithers
C.E. CREDITS: P.A.C.E. CE | Florida CE
Speakers
  • Regulatory Affairs Scientist , Smithers Viscient
    Biography
      Dr. Erick Nfon is a Regulatory Scientist with particular experience in environmental fate modeling and regulatory affairs. Dr. Nfon has spent 14 years working in Academia, Industry and at European Contract Research Organizations and regulatory consultancies. His responsibilities include environmental risk assessments, dossier preparation and submission, and the provision of scientific expertise and advice to support registration programs for plant protection products, biocides, pharmaceuticals, and general industrial chemicals.

    Abstract:
    DATE:  July 30, 2019
    TIME:   6:00am PT, 9:00am ET
     
    The current version of the EMA Guideline for the environmental risk assessment of human drugs was published in 2006. This guidance has now been revised ( a draft version was published on 15 November 2018 and is open for consultation until June 30, 2019).
     
    Amongst the notable changes are:
    • The introduction of a decision tree clarifying when ERA studies are required
    • The introduction of the term endocrine active substances to cover all substances that affect the development and/or reproduction
    • The introduction of guidance for the estimation of exposure to human pharmaceuticals via the food chain (secondary poisoning)
    • A revision to the tiered approach in testing
    • The introduction of tailored risk assessments for active substances with specific mode of action (e.g. antimicrobials and endocrine active substances) 
    Learning Objectives:
    • Understand revisions to EMA Guideline for the Environmental Risk Assessment of Human Drugs
    • Understand revision to the tiered approach to laboratory testing
    • Learn  about  “Endocrine Active Substances”
    • Understand tailored risk assessments for active substances with specific modes of action
     
     
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