Course description
Fundamentals of EU Agrochemical Regulations
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 online course.
Suitability - Who should attend?
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.
Outcome / Qualification etc.
During this 5-week online course you will:
- Ensure you fully understand the cut off criteria and data requirements under 1107/2009 to ensure compliance
- Get best practice advice for complex aspects of dossier preparation
- Take away the knowledge needed to deal with registrations and renewals
- Learn when to use the Zonal approach and be prepared with guidance on procedures and dossier structure
- Explore and overcome the challenges associated with the Risk Envelope approach
- Update on endocrine disruptor criteria in the EU and explore the impact on active substances
Training Course Content
- Module 1: Background/history
- Module 2: Active substance approval
- Module 3: Structure and content of an active substance dossier – part 1
- Module 4: Structure and content of an active substance dossier – part 2
- Module 5: Relevant information of active substance approval
- Module 6: Product authorisation by the zonal system – part 1
- Module 7: Product authorisation by the zonal system – part 2
- Module 8: Risk envelope, uniform principle and other relevant subjects
- Module 9: MRL’s
- Module 10: Project planning
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
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About provider
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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