Date: 6 April 2017
Location: AkzoNobel Arnhem
Time: 13.00 - 17.15
Title: Adversity in safety studies: How to set a NOAEL?
This meeting addresses the contemporary view on “Adversity in animal studies” and its consequences for deriving a NOAEL. The reason for this meeting is the flared up discussion whether to include organ function in setting a NOAEL, as recently supported by the Society of Toxicological Pathology (STP) in 2 of their recent publications. To underline the actuality of this topic, the EFSA recently published a Guidance of Biological Relevance which is open for comments (see link below).
In the first part of the meeting, the STP position on “adversity” will be highlighted and an alternative view on “adverse” will be presented. In a concluding presentation a comparison will be made of the potential consequences of the new concept of adversity on both the NOAEL and Bench Mark Dose approach.
In the 2nd part of the meeting, the new concept of adversity will be dealt with in an interactive workshop in which the attendees will discuss in small groups the setting of a NOAEL for a number of case studies.
13.00-13.30: Reception with coffee
13.30-13.35: Introduction by session chair
13.35-14.00: What is Adverse in animal safety studies? (visie van de Society of Toxicological Pathology)
Eveline De Rijk (Charles River, Den Bosch)
14.00-14.25: Another way to look at adverse - Pattern recognition in (immune)toxicity
Frieke Kuper (TNO)
14.25-14.50: Adversity of effects, NOAEL and Bench Mark dose approach
Bas Bokkers (RIVM)
15.05-16.30 Interactive workshop (4 case studies)
Moderators: Anja Slikkerveer en Liesbeth Heijink (Astellas)