Regulatory and applied toxicology

Three instructor-led online modules on how to handle SVHC substances and establish health-based safety levels for chemicals within different regulatory frameworks.

Choose one, two or all three modules depending on your need

Each live module addresses a topic that is a challenge when working with chemicals and having to meet regulatory compliance for human health and safety.

The modules cover the following three subjects:

  • How to derive Occupational Exposure Limits (OEL and OEBs) and Permitted Daily Exposures (PDE) for active pharmaceutical ingredients;
  • How to handle substances of very high concern (SVHC) and endocrine disruptors in various regulations;
  • How to make hazard assessment and derive tolerable exposure levels within REACH and other regulatory frameworks.

Pick the modules that suit you and get an enhanced understanding of the topics.

Learn how to support your toxicological decisions

Knowledge of toxicology and the properties of chemical substances is paramount when developing and marketing products – be it consumer products, pharmaceuticals, medical devices or other.

Substances must comply with regulatory requirements putting considerable demands on documentation to authorities and regulatory bodies.

You will learn how to collect data, how to identify critical effects and be introduced to different guidelines and methods.

Each module will include lectures by our senior toxicologists.

At each session you will have time to discuss toxicological issues and best practices with your instructors and fellow participants.

Is this training right for me?

Are you:

  • a chemical safety advisor,
  • a regulatory affairs professional or
  • a scientist involved in R&D of new products?

Do you:

  • have a good grasp of fundamental toxicology
  • have a need to understand more complex toxicological issues and their regulatory implications to support your decisions?

If yes, you can benefit from this online course.

Course details and important dates

The instructor-led modules have a duration of two hours each. The training takes place on Wednesdays on the following dates: 16 March, 23 March and 6 April 2022.

Sessions will take place  10:00 – 12:00 CET.

The maximum number of participants is 16 to ensure high quality training and skill development.

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

Three instructor-led online modules

One optional module:

350 excl. VAT
  •  

Two optional modules:

600 excl. VAT
  •  

Three modules:

950 excl. VAT
  •  
  •  
  •  
  • Each module includes links to pertinent regulations, guidelines and databases plus handout of course presentation and training certificate.

Your training team

Poul Bo Larsen

Poul Bo Larsen has more than 30 years of experience in health risk assessment of chemicals. He has participated in working groups in the EU and the OECD and as the Danish representative in ECHA's Risk Assessment Committee.

Poul’s comprehensive expertise includes regulatory toxicology, risk assessment, limit values, health impact of ambient air pollution, Occupational Exposure Limit (OEL and OEB), nanomaterials and REACH.

Reviewer of OEL background documents prepared by the Danish National Research Centre for the Working Environment.

Chief Toxicologist.

Brian Svend Nielsen

Brian Svend Nielsen has 20 years of professional experience in regulatory toxicology, chemicals regulation compliance and product safety assessment.

Brian has expert knowledge of human toxicology in the areas of hazard identification, exposure assessment and risk assessment of chemicals.

He is an expert in the EU Medical Devices Regulation (MDR) and the REACH chemicals legislation, particularly SVHCs and endocrine disruptors.

Principal Toxicologist and European Registered Toxicologist (ERT).

Astrid Skovmand

Astrid Skovmand has a back-ground in in vivo pharmacology and toxicology and has research experience in reproductive and developmental toxicity of nanomaterials.

Astrid performs risk assessment of chemicals and particles. She is also helping major pharmaceutical companies with biocompatibility of medical devices as well as assessment of chemicals for endocrine disruptive properties.

Toxicologist, PhD.

Save Your Seat Today!

Wednesdays 16 March, 23 March and 6 April 2022 from 10:00-12:00 CET.