The global agrochemical market is estimated to be worth over £50 billion, so if you’re looking to maintain your share of the EU market it is imperative to fully understand the regulatory requirements needed for approval.
With recent decisions from the EU on Glyphosate and continuing uncertainty around the interpretation of Regulation 1107/2009, regulatory issues should be at the forefront for any agrochemical company operating in Europe.
This course is designed to provide an overview of the EU regulatory landscape for registering agrochemicals, for those who are new to regulatory affairs alongside those who work in other departments as well.
Gain an understanding of how EU regulations will impact your regulatory affairs department and increase your cross-functional communication and problem solving skills with the help of this brand new online course.
What will you learn?
- Why the need to regulate plant protection products?
- Historical perspective of Regulation 1107/2009 and related regulations
- Candidates for substitution and comparative risk assessment (Art 24 + 50)
- Low risk active substances (Art 22 + 47)
- Data protection and confidentiality (Art 59 + 63)
- Avoidance of duplicate testing on vertebrates (Art 61 + 62)
- Definition of endocrine disruptors criteria and its impact on the registration of active substances
Active substance approval
- Article 4 criteria for approval/renewal
- Cut-off criteria
- Technical equivalence
- Brief overview of the approval process of the active substance
- Procedures for new a.s. and renewal
- Completeness check, evaluation by RMS and Peer Review by EFSA
- DAR/RAR/review report/conclusion report
Structure and content of an active substance dossier – part 1
- Introduction to data requirements
- What is in an active substance dossier – structure overview
- Document A, B, C, E, F, G, H and I
- Document D - What is a GAP?
- Document J
- Document KCA
- Document LCA
- Document MCA
- Document O
Structure and content of an active substance dossier – part 2
- Part 0: Introduction
- Document N1 chapter 1-3 (identity, phys/chem, further information)
- Document N1 chapter 4 (analytical methods)
- Document N1 chapter 5 (toxicology)
- Document N1 chapter 6 (residue)
- Document N1 chapter 7 (environmental fate)
- Document N1 chapter 8 (ecotoxicology)
- Document N1 chapter 9 and 10 (literature data and classification & labelling)
- Document N2-5
- Guidance documents on active substance for dossier preparation, procedures etc. to consider
Product authorisation by the zonal system – part 1:
- What is a product authorisation?
- Introduction to the zonal system
- Inter- and intrazonal steering committees
- Mutual recognition – intra- and interzonal
- Articles 4 and 43 criteria for product authorisation and renewal
- Procedures for submission and review
- Overview of (some) of the guidance documents
Product authorisation by the zonal system – part 2
How to structure your PPP dossier
- Administrative documents
- Document K
- Data active substance
Classification and labelling
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Over 2 days students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact email@example.com
Who is this course for?
This course is relevant to anyone who is just starting out in regulatory affairs for agrochemicals but also for professionals from other departments who need to develop their understanding of the regulatory environment.
- Regulatory Affairs
- Product Stewardship
Regulatory and Product
The course was interesting and helped me in my daily activities. The presenter was very professional and had great knowledge of regulatory issues.
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others