Online Seminar “Environmental risk assessment of medicinal products for human use”
tbd, 9:00 – 12:45 (CE(S)T)
An environmental risk assessment (ERA) is required as part of the marketing approval of pharmaceuticals in many geographic regions throughout the world. The assessment has to be conducted according to international guidelines, e.g., from European Medicines Agency (EMA) or U.S. Food and Drug Administration (FDA) to understand the behaviour of active pharmaceutical ingredients and to evaluate a potential risk in certain environmental compartments.
In the EU the requirements for an ERA of active pharmaceutical ingredients of medicinal products was introduced in 2006 and has been supplemented by various Q&A documents aimed at providing clarification and to harmonise the use of the still valid guideline from 2006. In the US an ERA has to follow the tiered approach laid out in the Guidance for Industry, Environmental Assessment of Human Drugs and Biologics Applications from 1998.
This online seminar provides introductory insights in the ERA of human medicinal products (non-GMOs) according to the EMA or FDA guideline and show differences in the procedure (e.g., exposure calculation). Both methodologies follow a tiered approach based on the results of tests on fate and effects.
A detailed explanation for the preparation of ERAs based on the regulatory requirements of EMA published in 2006 will complete the seminar. In addition, the impact of the new draft version of the EMA guideline e.g., for substances with specific mode of actions will be discussed.
Agenda of the Online Seminar
|08:45||Opening of the waiting room|
|09:00 – 10:00||I. Introduction and Phase I assessment
|10:00 – 10:40||II. PBT assessment according to EMA guideline
|10:40 – 11:00||Break|
|11:00 – 12:30||III. Phase II assessment according to EMA guideline
General overview of Phase II
|12:45||End of seminar|
The presentations are held in English. There will be time to answer your questions.
ACA-pharma concept GmbH
Telefon: +49 (0) 341-223 292 36