Science Beyond regulatory compliance

PLANT PROTECTION PRODUCTS - regulatory

Fundamentals and Challenges of Regulation (EC) No. 1107/2009

Programme

Part 1

Regulation (EC) No. 1107/2009

•Overview of the regulation
•The various procedures concerned

Part 2

Zonal assessment

•Comparison of Zonal assessment: Northern, Central and Southern zones
•Interactions between the Notifier and the Competent Authorities

Part 3

Dossier Requirements

•New requirements: for which substances?
For which products?
•Ensuring the compliance of an existing dossier with the new regulatory requirements

Part 4

Study case(s)

1 day

1 100 Excl VAT

Objectives

►  Understand the regulatory procedures for active substances and products

►  Understand zonal assessment and dRR dossiers

►  Understand the content of the regulatory dossiers for approval application of substances and product authorisation

Target

►  Regulatory Affairs

►  Products/ Active Substance Managers

Fiche pdf

Trainers

Caroline VILLE
Senior Regulatory Affairs
more detailsCaroline joined CEHTRA in 2004 as a regulatory affairs consultant after 3 years at ADAMA (ex Makhteshim Agan France). She holds an MSc in Environmental Engineering, from Coventry university, UK. Caroline brings her expertise to the Plant Protection sector, Biocides and Reach projects. For PPP projects Caroline coordinates projects (EU, zonal and national dossiers), provides regulatory support for all procedures and is the main contact with the authorities and manages the portfolios. For the dossier preparation and study monitoring, she is involved in the phys chem properties, analytical methods and residue section.
Marie-Hélène LIÉGEOIS
Senior Regulatory Affairs
more detailsMarie-Hélène has a PhD in Biology-Agrochemistry on the subject "Efficiency and environmental impact of an anti-wireworm insecticide, fipronil, in simplified agrosystem" and 17 years’ experience with agrochemicals. She started as a Research Technician at Rhône-Poulenc Agro where she worked on artificial seeds and on penetration of active substances, fungicides, in the vegetal. After her PhD, she worked as a Registration Manager for garden and amenity products at Scotts France (6 years) and as a Country Registration Manager for agricultural products at BASF France (11 years). She joined CEHTRA in 2016 as a Regulatory Affairs Consultant where she is involved in the coordination / preparation of registration dossiers for active substance substances and PPP.
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