Webinars

JUL 30, 2019 6:00 AM PDT

Overview of the new ERA Guidelines: Changes and Revisions

Sponsored by: Smithers

4

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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JUL 30, 2019 6:00 AM PDT

Overview of the new ERA Guidelines: Changes and Revisions

Sponsored by: Smithers

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