Kerona Scientific PPP Regulatory Academy

Comprehensive Virtual Training

9 modules over the course of 12 months*

Module 1: Overview of the EU Regulatory Environment for Plant Protection Products under Regulation (EC) No 1107/2009

Two mornings: Wed 10th April & Thurs 11th April 2024, 09:00h-12:00h GMT Dublin

Introduction to the PPP Regulatory Academy

Overview of the Regulation (EC) No 1107/2009:

• Active substance (a.s.) approval
• Active substance renewal (AIR)
• EU Zonal system for product authorisation
• Product authorisation (Article 33)
• Product re-authorisation (Article 43)
• Mutual recognition (Article 40)
• Minor Use (Article 51)
• Emergency use (Article 53)
• Overview of data protection
• Data gap analysis and data matching

Links to other related legislation:

• The EU CLP process
• The EU MRL process
• General Food Law and Transparency Regulation

Module 2: Physical-Chemical Requirements for Active Substances (a.s.) and Plant Protection Products (PPPs)

Wed 8th May 2024, 09:00h-12:00h GMT Dublin

Overview of the data requirements for physical-chemical properties

• Physical-chemical requirements for the a.s. under Commission Regulation (EU) No 283/2013
  • Links to classification of the a.s.
  • Links to other sections of the data requirements
• Physical-chemical properties of the plant protection product (PPP) under Regulation (EU) No 284/203
  • Links to classification and labelling of the PPP
  • Consideration of requirements for different formulation types
  • Significant and non-significant changes of chemical composition according to SANCO/12638/2011

Module 3: Analytical Requirements for a.s. and PPPs

Thurs 9th May 2024, 09:00h-12:00h GMT Dublin

Introduction to the analytical method validation

• Method validation for the technical a.s. according to SANCO/3030/99 rev.5
• Method validation for the PPP according to SANCO/3030/99 rev.5
• New validation requirements according to SANTE/2020/12830 rev.1

Module 4: Toxicological Requirements for a.s. and PPPs

Two mornings: Wed 29th May & Thurs 30th May 2024, 09:00h-12:00h GMT Dublin

Data requirements for the a.s. under Commission Regulation (EU) No 283/2013 including

• Studies required
• Available EU guidance
• Derivation of end-points used for risk assessment
• Introduction to endocrine disruption (ED)
• Links to other sections of the data requirements

Data requirements for the PPP under Commission Regulation (EU) No 284/2013 including

• Studies required
• Classification and labelling for toxicological hazards
• Dermal absorption
• Exposure assessment (operator/worker/bystander/resident) using EFSA calculator

Module 5: Residues and Consumer Exposure

Two mornings: Wed 19th June & Thurs 20th June 2024, 09:00h-12:00h GMT Dublin

Overview of the residue data requirements including

• Plant metabolism
• Residue definition
• Extent of residue data required
• Northern/Southern zones for EU residue trials
• Rules for extrapolation of data
• Major and minor crops
• Maximum residue levels (MRLs)
• Consumer risk assessment – EU PRIMo model

Links to other sections of the data requirements

Module 6: Environmental Fate and Behaviour for a.s. and PPPs

Two mornings: Wed 11th Sept & Thurs 12th Sept 2024, 09:00h-12:00h GMT Dublin

Data requirements for the a.s. under Commission Regulation (EU) No 283/2013 including

• Studies required
• Available EU guidance
• Consideration of metabolites
• Links to other sections of the data requirements

Data requirements for the PPP under Commission Regulation (EU) No 284/2013 including

• Studies required
• Risk assessment – models and scenarios
• Risk mitigation in the EU
• Consideration of metabolites

Consideration of national specific requirements

Module 7, Part 1: Ecotoxicology for a.s. and PPPs

Two mornings: Wed 16th Oct & Thurs 17th Oct 2024, 09:00h-12:00h GMT Dublin

Data requirements for the a.s. under Commission Regulation (EU) No 283/2013 including

• Studies required
• Available EU guidance
• Derivation of end-points used for risk assessment
• Consideration of metabolites and impurities
• Links to other sections of the data requirements

Data requirements for the PPP under Commission Regulation (EU) No 284/2013 including

• Studies required
• Classification and labelling for ecotoxicological hazards

Module 7, Part 2: Ecotoxicology for a.s. and PPPs

Two mornings: Wed 13th Nov & Thurs 14th Nov 2024, 09:00h-12:00h GMT Dublin

Ecotoxicological risk assessments:

• Role of regulatory ecotoxicology
• Principles of risk assessment
• Risk assessment for birds and mammals
• Risk assessment for aquatic organisms
• Risk assessment for arthropods (bees and other non-target arthropods)
• Risk assessment for soil macro- and meso-organisms
• Risk assessment for non-target terrestrial plants

Options for higher tier

Module 8: Efficacy Data Requirements

Wed 11th Dec 2024, 09:00h-12:00h GMT Dublin

Overview of the efficacy data requirements including

• Relationship between the BAD and dRR Section 3 (efficacy section)
• EU EPPO zones for efficacy data trials
• Extent of efficacy data required (major vs minor crop/pest)
• Types of data required (efficacy, selectivity, taint, processing studies)
• Rules for extrapolation of data
• Resistance management

Minimum effective dose (MED)

Module 9: Overview of Dossier Preparation for EU Regulatory Submissions

Thurs 12th Dec 2024, 09:00h-12:00h GMT Dublin

Overview of EU dRR Dossier Preparation

• Dossier purpose (AIR, national authorisation)
• Dossier format (OECD, IUCLID)
• Core and national requirements
• Confidential volume (Document C)

*min 8 delegates

The detailed contents of each module are subject to change.