Wednesday, 16 April 2022
Module 1: OEL and PDE derivation for pharmaceutical ingredients
This module specifically addresses the pharmaceutical industry. We will define the terms Occupational Exposure Limit (OEL) and Permitted Daily Exposure (PDE) and explain how they are used for different purposes. This will include guidance on how to collect data for OEL and PDE derivations, methods for deriving OEL and PDE, and relevant guidelines. Finally, we will explain how to handle candidates for active pharmaceutical ingredients (APIs) with very sparse data and the OEB (Occupational Exposure Banding) system.
Registration deadline: 11 April 2022
Wednesday, 23 March 2022
Module 2: Regulation of substances of very high concern (SVHC) including endocrine disruptors
What is a substance of very high concern and how are the critical effects defined? We will explain how to cope with SVHCs in various regulations (REACH, biocides/pesticides, cosmetics, medical devices and food regulation). We will describe how to look for and identify SVHCs and potential endocrine disruptors, including obligations and what to do in the different regulatory regimes. We will wrap up with a status on the regulation of endocrine disrupting substances (EDCs).
Registration deadline: 18 March 2022
Wednesday, 6 April 2022
Module 3: How to derive tolerable exposure levels
In this module we will define various types and terms of tolerable exposure levels and show in what way you can use them. This will include an explanation of relevant types of hazard data and how to collect these. You will learn to identify critical effects and a critical no-observed-adverse-effect-level (NOAEL) for derivation of tolerable exposure levels and how to adjust the NOAEL to relevant dose metrics. We will explain how to use assessment factors and how to evaluate non-threshold effects. We will conclude by clarifying similarities and differences in guidelines and methods and how they are implemented in various regulatory schemes. Examples will be given within regulatory areas such as REACH, biocides/pesticides, cosmetics and food.
Registration deadline: 1 April 2022