Who will benefit from this course?
This course will benefit newly employed Regulatory Affairs managers and people who need an overview of the authorisation process of 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 authorisation process and 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 and the process of getting a plant protection product authorised in the EU.
You will learn about the zonal system, mutual recognition, Uniform Principles, the risk envelope approach, fees, classification and labelling. You will also be acquainted with knowledge about timelines, guidance documents and integrated pest management.
Course Curriculum
- Introduction (4:24)
- Lesson 1 What is a product authorisation (6:59)
- Lesson 2 Introduction to the zonal system (2:22)
- Lesson 3 Inter- and intrazonal steering committees (5:54)
- Lesson 4 Mutual recognition (8:59)
- Lesson 5 Articles 4 and 43 criteria (8:58)
- Lesson 6 Procedures for submission and review (9:04)
- Lesson 7 Overview of (some) of the guidance documents (5:37)
- Lesson 8 Timelines (12:00)
- Lesson 1 What is EU MRLs and when are MRLs required (9:04)
- Lesson 2 Historical perspective on MRLs (6:43)
- Lesson 3 The principle on setting an MRL (16:35)
- Lesson 4 How to apply for an MRL (8:59)
- Lesson 5 Assessment of cumulative and synergistic effects (7:39)
- Lesson 6 How to comply with the fixed MRLs (7:01)
- Lesson 7 MRLs outside EU (CODEX, US) (7:33)
- Lesson 1 Are there other options than the zonal system (4:04)
- Lesson 2 What can be done after an authorisation has been granted (10:59)
- Lesson 3 What is an emergency authorisation (Art 53) (4:37)
- Lesson 4 Test for research and development purposes (4:51)
- Lesson 5 Integrated Pest Management (IPM) (5:20)
- Lesson 6 From idea to authorisation (5:21)
- Lesson 7 Costs and how long does it take (7:34)
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