Who will benefit from these courses?
This course will benefit newly employed Regulatory Affairs managers and people who need an overview of the approval process of an active substance, the authorisation process of a plant protection product and an overview of the dossier content of both. All without being too detailed. It could also be Regulatory people from outside Europe who wish to get to know how the regulatory framework in Europe works.
What is the purpose of these courses?
The purpose of this course is to give an overview of the approval process and the authorisation process including the elements involved. It is a great overview for people recently joining Regulatory Affairs of plant protection products or people not in Regulatory Affairs but would like to see “the bigger picture”.
You will gain knowledge about Regulation EC 1107/2009, important Articles of the Regulation and the process of getting a plant protection product authorised in the EU. You will also gain knowledge about Regulations EC 283/2013 and EC 284/2013 and how a dossier of an active substance and a plant protection product is structured in the EU.
You will get familiar with important articles of Regulation (EC) 1107/2009, the approval process and the procedures, authorities and documents involved. You will also be acquainted with knowledge about timelines, guidance documents, data gap analysis and integrated pest management.
You will learn about the zonal system, mutual recognition, Uniform Principles, the risk envelope approach, fees, classification and labelling.
You will learn about the data requirements, the structure of a active substance dossier including document N1, the structure of a product dossier including the dRR and what information must be presented in each document/section of the dossier.
You will also be acquainted with knowledge about the content of the sections on physical/chemical properties, efficacy, analytical methods, toxicology, residue, environmental fate and ecotoxicology including an introduction to some of the risk assessments involved.
Hi, I am Marianne
Marianne Thuen Jakobsen is an Independent Regulatory Affairs Consultant with extensive experience in EU agrochemical regulations.
Following 10 years in the industry working as a Patent Specialist, QA specialist and Regulatory Affairs Specialist, Marianne set up her own regulatory consultancy in 2016. Through consultancy projects, she facilitates approvals for plant protection products in the Northern Zone of the EU and gets involved in complex regulatory cases.
Marianne has a deep understanding of her areas of expertise and is not locked by bureaucracy and tight specifications within her area of competencies. Furthermore, she is flexible regarding tasks and time - Marianne believes in doing things by the book and setting high standards for the outcome of her future work.
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