Dossier structure
Sections, administrative documents and technical summaries.
Regulatory TrainingLaw 34-18Practical workshops
Preparing Plant Protection Product Registration Dossiers
Structure a coherent dossier, understand authority expectations and prepare technically robust responses through a practical approach.
11–14 November 2026Congress Palace · Salé32 hours · 4 days
Early bird: MAD 20,500 excl. taxStandard price: MAD 23,000 excl. tax
From strategy to final dossier
Understand, structure and defend a regulatory dossier
The course explains the assessment logic for a plant protection product and the links between every scientific and administrative section.
- Read Law 34-18, applicable texts and procedural codes.
- Identify mandatory data, gaps and critical points.
- Structure administrative, scientific and biological-efficacy sections.
- Check consistency between specifications, studies, uses and labelling.
- Prepare answers to additional-information requests.
Practical approach
Exercises directly connected to regulatory work
Checklists, case studies, document analysis and dossier-preparation simulations.
Scientific data
Physicochemistry, toxicology, residues, ecotoxicology and efficacy.
Compliance analysis
References, methods, GLP/GEP and document consistency.
Workshops
Case studies and guided dossier-preparation exercises.
Programme
Detailed programme — 11 to 14 November 2026
32 hours in person, including workshops and simulations.
01Day 1 · Wednesday 11/11Legislative and regulatory framework
Legislative and regulatory framework
Law 34-18, applicable texts, competent authority, obligations, definitions and scope.
02Day 2 · Thursday 12/11Procedural codes and checklist
Procedural codes and checklist
Administrative and technical requirements, study compliance, references and dossier organization.
03Day 3 · Friday 13/11Active substance, formulated product and methods
Active substance, formulated product and methods
Specifications, purity, composition, stability, physicochemical properties and analytical methods.
04Day 4 · Saturday 14/11Toxicology, residues and risk assessment
Toxicology, residues and risk assessment
ADI, AOEL, NOAEL, exposure, residues, ecotoxicology and an integrated case study.
Regulatory architecture
The six sections of the dossier
Cross-sectional reading ensures consistency between the product, studies, uses and conclusions.
Administrative
Identity, authorizations, certificates, declarations, labelling and legal documents.
Physicochemical
Specifications, composition, properties, stability and analytical methods.
Toxicology
Toxicity, genotoxicity, reference values and operator risk assessment.
Residues
Metabolism, residue trials, MRLs and dietary exposure.
Ecotoxicology
Non-target organisms, environmental fate and risk assessment.
Biological efficacy
GEP trials, efficacy, selectivity, rates, uses and agronomic justification.
Target audience
For teams preparing or assessing dossiers
Designed for companies, consultants, GEP organizations and regulatory professionals.
Regulatory affairs
Registration managers, project leaders and regulatory assistants.
R&D and GEP organizations
Engineers, scientific experts and study managers.
Importers and distributors
Teams involved in compliance and product market access.
Practical information
Prices and included services
Bilingual French/English support is available depending on session organization.
Early bird price
MAD 20,500 excl. taxBefore 15 October 2026.
Standard price
MAD 23,000 excl. taxAfter 15 October 2026.
Included
Lunch, two coffee breaks per day, course materials and attendance certificate.
First edition and community
A course enriched by professional exchange
Real photographs from the first edition illustrate the classroom work, workshops, discussions and group dynamic.
