NEW: 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 22^nd March & Thurs 23^rd March 2023, 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 26^th April 2023, 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 27^th April 2023, 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 24^th May & Thurs 25^th May 2023, 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 21^st June & Thurs 22^nd June 2023, 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 20^th Sept & Thurs 21^st Sept 2023, 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 18^th Oct & Thurs 19^th Oct 2023, 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 22^nd Nov & Thurs 23^rd Nov 2023, 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 24th Jan 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 25th Jan 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.

Introducing the Key Trainers:

Dr. Irene McGrath

Irene is the Managing Director of Kerona Scientific Ltd. in Ireland. Irene studied Analytical Science and a PhD in Chemistry at Dublin City University before working in a variety of senior regulatory roles in the plant protection industry and as founder and senior consultant in a regulatory consultancy. Irene founded Kerona Scientific Ltd. in 2014 and manages the regulatory team of consultants, working with clients worldwide on all aspects of data gap analysis, dossier preparation and strategic regulatory advice. She has spent almost 30 years managing regulatory departments in industry and working as a consultant for the regulation of plant protection products, biocides, plant biostimulants and fertilisers in the EU.

Catherine Alhaddad

Catherine has a BSc in Chemistry and an MSc in Analytical Toxicology. She has a broad range of scientific work experience moved into regulatory affairs in 2007 working in leading international consultancies on agrochemical, biocide, REACH, and cosmetics registrations. Catherine has significant experience in reviewing scientific data, data gap analysis and dossier preparation as well as poison centre notification. At Kerona, Catherine focuses on exposure modelling and risk assessments for biocides, plant protection and REACH as well as modelling and argumentation for special cases. Catherine speaks fluent Arabic and is the main contact point for toxicology and analytical chemistry

Dr. Neus Rodriguez Sanchez

Neus has a BSc in Biological Sciences and an MSc in Aquaculture. She completed her PhD at Liverpool John Moores University in collaboration with the Norwegian Institute for Water Research. The PhD focused on the development of computational approaches (e.g. QSARs, structural alerts) and in vitro methods to assess the toxicity and bioaccumulation of organic chemicals in aquatic organisms. Neus has worked as a regulatory ecotoxicologist for the UK CRD, where she was responsible for the registration of plant protection products and biocides in the CEU zone. At Kerona, she specialises in risk assessments for ecotoxicology dossier sections and the prediction of toxicity endpoints for use in a regulatory context using QSAR and ECOSAR. Neus also prepares the residue section and consumer risk assessments. Neus is a native Spanish speaker and is the main contact point for ecotoxicology.

Amanda Araujo de França

Amanda is an agronomist and specialist in soil chemistry and fertilisers. She has an M.Sc. in Chemistry from the Federal University of Paraná (Brazil), and a B.Sc. in Agronomy from the Federal University of Viçosa (Brazil), with an exchange year at ENSAIA, the National School of Agronomy and Food Sciences in Nancy, France. As a research assistant and PhD Candidate at TU Munich in Germany, she specialized in plant nutrition and soil science, investigating the efficiency and fate and behaviour of nutrients from fertilisers in water, air and soil. Prior to joining Kerona, Amanda worked as an agronomist in Brazil, France, Poland and Germany. Amanda is a native Portuguese speaker and is fluent in English and German. At Kerona, Amanda is the main contact point for fertiliser/plant biostimulants, environmental fate and behaviour modelling, as well as Portuguese submissions.