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.
You May Also Like
DEC 10, 2024 | 9:00 AM
To-date, proteomic analysis has been severely limited in scale and resolution. Analyzing protein samples using an intact, single-molecule approach holds th...
OCT 02, 2024 | 7:30 AM
De novo gene synthesis and protein expression are established technologies that can give access to nearly any target DNA or protein sequence, allowing for engineering of biologics. In this p...
Speaker:
Claudia Chiocchini
Presented at: Cancer Research & Oncology Virtual Event Series 2024
Sponsored By: Thermo Fisher Scientific
Sponsored By: Thermo Fisher Scientific
Loading Comments...
Please update your information
Certificate of Attendance
Thank you for choosing Labroots. Please note that a Certificate of Attendance does NOT count towards Continuing Education Credits.
DOWNLOAD CERTIFICATE
DOWNLOAD CERTIFICATE
You must watch the entire webinar to receive your certificate of attendance.
You must attend the event before receiving your certificate of attendance.
You must register for the event first.
Certificate is no longer available for this event.
You must be logged in to retrieve your certificate.
Finish Registering
Attendees