Plant Protection Product Registration Dossiers
Build a coherent dossier, understand the authority’s expectations and prepare strong technical responses through a practical approach.
Understand, structure and defend a regulatory dossier
The course explains the evaluation logic for plant protection products and the links between all dossier sections.
- Interpret Law 34-18, applicable texts and procedural codes
- Identify mandatory data, gaps and critical points
- Structure administrative, scientific and biological efficacy sections
- Assess consistency between specifications, studies, uses and labelling
- Prepare responses to authority questions and technical exchanges
Exercises directly connected to regulatory work
Checklists, case studies, document review and dossier-preparation simulations.
Dossier structure
Sections, administrative documents and technical summaries.
Scientific data
Physico-chemistry, toxicology, residues, ecotoxicology and efficacy.
Compliance review
References, methods, GLP/GEP and document consistency.
Workshops
Case studies and preparation exercises with trainer support.
Detailed programme — 11 to 14 November 2026
32 in-person hours including workshops and simulations.
| Day | Module | Main content |
|---|---|---|
| Day 1 Wednesday 11 Nov. |
Legislative and regulatory framework |
Law 34-18, applicable texts, competent authority, obligations, definitions and scope. |
| Day 2 Thursday 12 Nov. |
Procedural codes and checklist |
Administrative and technical requirements, trial compliance, references and dossier organisation. |
| Day 3 Friday 13 Nov. |
Active substance, formulated product and methods |
Specifications, purity, composition, stability, physico-chemical properties and analytical methods. |
| Day 4 Saturday 14 Nov. |
Toxicology, residues and risk assessment |
ADI, AOEL, NOAEL, exposure, residues, ecotoxicology and an integrated case study. |
Day 1 — 11 November
Legal and regulatory framework
Law 34-18, competent authority and obligations.
Day 2 — 12 November
Procedural codes
Administrative and technical checklist and trial compliance.
Day 3 — 13 November
Active substance and formulated product
Specifications, stability and analytical methods.
Day 4 — 14 November
Toxicology and residues
Reference values, exposure and case study.
The six dossier sections
A cross-sectional review is essential to maintain consistency between product, studies, uses and conclusions.
Administrative
Identity, authorisations, certificates, declarations, labelling and legal documents.
Physico-chemical
Specifications, composition, properties, stability and analytical methods.
Toxicological
Toxicity, genotoxicity, reference values and operator risk assessment.
Residues
Metabolism, residue trials, MRLs and dietary exposure.
Ecotoxicological
Non-target organisms, environmental fate and risk assessment.
Biological efficacy
GEP trials, efficacy, selectivity, rates, uses and agronomic justification.
For teams preparing or assessing dossiers
Suitable for companies, consultants, GEP organisations and regulatory professionals.
Regulatory affairs
Registration managers, project leaders and regulatory assistants.
R&D and GEP organisations
Engineers, scientific experts and study or trial managers.
Importers & distributors
Teams involved in product compliance and market access.
Fees and services
French/English bilingual support is available depending on course arrangements.
Early-bird fee
19,500 MAD excl. tax
Before 15 October 2026.
Standard fee
22,000 MAD excl. tax
After 15 October 2026.
Included
Lunch, two coffee breaks per day, materials and attendance certificate.