Dossier content - active substance and plant protection dossier

Who will benefit from this course?

This course will benefit newly employed Regulatory Affairs managers and people who need an overview of the dossier content of an active substance and a plant protection product 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 this course? 

The purpose of this course is to give an overview of the dossier content of an active substance dossier and a product dossier. It is a great overview for people recently joining Regulatory Affairs of plant protection products or people not in Regulatory Affairs but would like try to see “the bigger picture”. 

You will gain knowledge about Regulation EC 1107/2009, EC 283/2013 and EC 284/2013 and the how a dossier of an active substance and a plant protection product is structured in the EU.  

You will learn about the data requirements, the structure of a a.s. 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.