THE BASICS

Understand the methodology of biological assessment in accordance with EN ISO 10993-1
Assess the conformity of a biological assessment plan

Understand the obligations under REACH and the impact/penalties in the event of non-compliance
Know how to draw up an extended safety data sheet
As a downstream user, know how to check your own compliance with supplier SDSs
Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS

Addressing the stages of an application for authorisation of a family of biocidal products :
- Similarity of composition & grouping of co-formulants
- Similarity of uses
- Similar level of risk and efficacy
Addressing the various points to be taken into account when dividing biocidal product families for current evaluations

Areas: food contact, cosmetics and pharmaceuticals

Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging
Acquire an overview of the regulatory texts applicable to materials
Be familiar with the essential requirements and specific features of this legislation
Understand a container/content risk assessment (LMS)

Understand the obligations under REACH
How to use CHESAR to carry out a CSA (Chemical Safety Assessment)
Be able to generate a CSR (Chemical Safety Report) under CHESAR
Comply with ECHA expectations

How to navigate and enter data in IUCLID
Be familiar with the main non-technical sections of a REACH dossier and know how to complete them
Be able to proofread the technical sections of a REACH dossier
Know how to use the various features of IUCLID (exports, validation wizards)
Be able to submit a dossier in REACH IT

Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023.

Understanding regulatory procedures for active substances and products
Understanding zonal assessment and dRR dossiers
Understanding the content of dossiers and the pitfalls to avoid

Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs
Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc.

Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment.
Be able to spot the pitfalls of studies and know how to avoid them

Knowing and understanding Cosmetics Regulation 1223/2009
Understand the risk assessment of a cosmetic product
Identify areas for improvement in order to comply with regulatory obligations

Understand the role of toxicology in the life of substances in accordance with regulations
Understanding the main tests, their difficulties and the issues involved
Optimising interaction between managers and experts