Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies

Objectives.

Understand the role of toxicological studies in Novel Food dossiers.
Identify the types of relevant studies depending on the nature of the product.
Read and interpret key data from study reports.
Identify quality and compliance criteria (OECD, GLP).
Efficiently manage and communicate with subcontracted laboratories.

Place	Horaire	Price	Language	Access time
Online	7 hours	from 690€ (HT)	French	2 months

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Objectives.

Understand the role of toxicological studies in Novel Food dossiers.
Identify the types of relevant studies depending on the nature of the product.
Read and interpret key data from study reports.
Identify quality and compliance criteria (OECD, GLP).
Efficiently manage and communicate with subcontracted laboratories.

Program.

Part 1 - Introduction – Context and Regulatory Framework
The role of toxicological studies in Novel Food assessments
EFSA requirements and relevant guidance documents
When studies are required (and when they are not)

Part 2 - Assessment of Genotoxic Effects
Why EFSA emphasizes genotoxicity
Standard studies: Ames test, micronucleus assay, chromosomal aberrations
Interpretation of results and acceptability criteria
Limitations and interpretation caveats

Part 3 - Assessment of Systemic Toxicity
Subchronic toxicity studies (90 days – OECD Guideline 408)
Key concepts: NOAEL, LOAEL, adverse effects, safety margins
Parameters monitored: weight, organs, blood, histopathology, etc.
How to read a GLP-compliant study report

Part 4 - Assessment of Reproductive and Developmental Toxicity
When are these studies required?
Types of studies (OECD 421/422, prenatal and postnatal development)
Common data gaps and EFSA expectations
Strategic considerations: justifying absence or planning studies

Part 5 - Toxicokinetic Evaluation
Is there a need for ADME / toxicokinetic studies?
What parameters are evaluated?
How do they impact toxicity studies and risk assessment?

Part 6 - Oversight and Management of Outsourced Studies
Best practices for overseeing subcontracted studies
How to select a laboratory (GLP compliance, Novel Food experience)
Key points to validate in a study protocol before initiation
Communication and deliverables expected for an EFSA dossier

Part 7 - Final Session – Q&A and Exchange
Addressing participants’ specific questions
Sharing experiences and best practices

Methods used.

The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt.

To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning.

Audience.

Regulatory Affairs Managers, R&D Project Managers and Quality Managers.

Prerequisites.

This training course is intended for participants with a basic knowledge of molecular and cellular biology, as well as some understanding of physiology. These prerequisites are essential to ensure a good understanding of the concepts covered, particularly the mechanisms of toxic effects and the interpretation of systemic toxicity data.

What our customers say

"I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges."

Certification QUALIOPI - Action de formation

La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION.

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About CEHTRA

We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe.

Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products.

With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc...