Regulatory Affairs Scientist , Smithers Viscient
BIOGRAPHY
Speaker
Event Date & Time
DATE: July 30, 2019
TIME: 6:00am PT, 9:00am ET
Abstract
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
Webinars will be available for unlimited on-demand viewing after live event.
LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.
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