+49 341 223 292 36

Online Seminar “Environmental risk assessment of medicinal products for human use”

12.10.2022  9:00 – 12:45 (CEST)
345.00 €

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

  • • General overview of the ERA process
  • • EMA and FDA guidelines
    • – Specific regulatory requirements, exemptions
    • – Tiered approach EMA vs. FDA
    • – Phase I assessment (EMA)/ exposure calculation (FDA)
  • including discussion
10:00 – 10:40 II. PBT assessment according to EMA guideline

  • • Embedding in the ERA process
  • • Screening steps
  • • Definite assessment for P, B, and T
  • including discussion
10:40 – 11:00 Break
11:00 – 12:30 III. Phase II assessment according to EMA guideline
General overview of Phase II

  • • Phase II, Tier A (physico-chemical properties, aquatic compartment, microorganisms,
  •    bioconcentration, sediment and terrestrial compartment; Risk assessment; specific considerations
  •    for endocrine active substances)
  • • Exemplary strategy considerations for Phase II, Tier B (compartment specific refinement)
  • • Comparison with FDA tiered approach
12:30 Final discussion
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

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