Who will benefit from this course?
This course will benefit newly employed Regulatory Affairs managers and people who need an overview of the approval process 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 approval 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 important Articles of the Regulation. You will get familiar with the approval process and the procedures, authorities and documents involved. You will also be acquainted with knowledge about timelines, guidance documents, data gap analysis and integrated pest management.
Course Curriculum
- Introduction (3:50)
- Lesson 1 Background for Directive 91414 (3:21)
- Lesson 2 Historical background of pesticide legislation (9:21)
- Lesson 3 Endocrine disruptors (9:56)
- Lesson 4 Candidates for substitution (5:33)
- Lesson 5 Comparative risk assessment (6:57)
- Lesson 6 Low-risk and basic substances (6:20)
- Lesson 7 Data protection (4:53)
- Lesson 8 Confidentiality (3:01)
- Lesson 9 Avoidance of duplicate testing (4:15)
- Lesson 1 Article 4 criteria for approval and or renewal (9:17)
- Lesson 2 Cut-off criteria (7:16)
- Lesson 3 Legislation on safeners, synergists and co-formulants (7:21)
- Lesson 4 Overview of the approval process (6:42)
- Lesson 5 Procedures for new active substances and renewal (5:45)
- Lesson 6 Completeness check (3:15)
- Lesson 7 Evaluation by Rapporteur Member State and peer review by EFSA (5:50)
- Lesson 8 DAR and RAR (3:31)
- Lesson 9 Conclusion Report and Review Report (5:42)
- Lesson 10 Confirmatory data (5:31)
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