Euregulator

Regulatory Strategy, Defined


It’s All About the Dose

It’s All About the Dose – EUREGULATORy Academy
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EUREGULATORy Academy · Course

It’s All About
the Dose.

How one parameter shapes the entire plant protection regulatory dossier — and why the effects are often not what you would expect.

🕒 4 hours
💻 Online or in-person
🌍 English / Italian
📋 All levels

Built for everyone
who works with PPP dossiers.

Whether you are just entering the regulatory world or have years of experience in a specific area, this course gives you a complete picture of how dose and concentration affect every section of a plant protection product dossier.

It is particularly valuable for professionals who work in one area of the dossier and want to understand how their work connects to — and is affected by — decisions made elsewhere.

📢

Marketing & Product Management

Understand the regulatory implications of dose decisions before they reach your regulatory team — and avoid costly surprises.

🌱

Efficacy & Field Trial Professionals

See how the doses you test in the field ripple through the entire dossier — from residues to environmental exposure.

⚖️

Regulatory Professionals (all levels)

Build a complete cross-disciplinary view of the dossier — essential for junior professionals and a valuable refresh for experienced ones.

A complete picture of the dossier —
through the lens of dose.

01

Understand all dossier sections

Get a clear overview of every section of a PPP dossier — physico-chemical properties, residues, toxicology, ecotoxicology, and efficacy.

02

See how dose connects everything

Understand how changes in dose and concentration propagate through the entire dossier — often in ways that are far from obvious.

03

Learn from real case studies

Analyse real regulatory cases where dose effects were counterintuitive — including products where 2-year studies had to be repeated.

04

Make better regulatory decisions

Apply cross-disciplinary thinking to your own regulatory work — whether in marketing, field trials, or regulatory affairs.

05

Communicate across disciplines

Speak the language of every dossier section — and understand the constraints and concerns of colleagues in other areas.

06

Spot counterintuitive risks early

Recognise the dose-related traps that catch even experienced regulatory professionals — before they become dossier problems.

Course structure.

Introduction

Why This Course

Why dose is the single most important parameter in a PPP dossier — and why its effects across dossier sections are systematically underestimated.

Module 1

Physico-Chemical Properties

How dose and formulation concentration affect physicochemical characterisation and what this means for downstream assessments.

Formulation Concentration
Module 2

Residues

The relationship between application dose, field trial design, and MRL setting — including how dose changes can trigger new supervised residue trials.

MRL Supervised trials GAP
Module 3

Toxicology

How dose affects operator, worker, bystander and resident exposure assessments — and the conditions under which 2-year studies need to be repeated.

AOEL Exposure assessment Long-term studies
Module 4

Ecotoxicology

The impact of dose on environmental exposure and risk assessment for aquatic organisms, birds, mammals, bees, and soil organisms.

Aquatic exposure Non-target organisms FOCUS
Module 5

“Efficacy Against Everything”

How efficacy data and label claims interact with dose — and the regulatory implications of changing application rates after authorisation.

Label Efficacy trials Post-authorisation

When the dose surprises you.

💧

The water volume that rejected a product

A product that passed all toxicological and environmental assessments — but was rejected because of the volume of water used in application. A counterintuitive case that changed how we think about spray concentration.

Covered in Module 4
📐

LWA and dose per hectare

How the relationship between label water allowance and dose per hectare creates regulatory traps — and why getting this wrong can invalidate years of trial data.

Covered in Module 5
🔬

And more…

Additional real-world cases from toxicology, residues, and ecotoxicology — including products where small dose changes triggered the need to repeat multi-year studies.

Throughout the course

Flexible delivery,
practical content.

🕒

4 hours

Compact and focused — designed to deliver maximum value without taking you away from work for days.

💻

Online

Self-paced online delivery with video lessons, slides, and downloadable materials.

🏢

In-person

Available as an in-person workshop for teams and organisations. Contact us for group bookings.

🌍

English / Italian

Available in both English and Italian — choose your preferred language at enrolment.

Stefano Ravagli

Taught by the person
who lived these cases.

I am Stefano Ravagli, founder of Euregulator. The case studies in this course are not hypothetical — they are real regulatory situations I encountered during decades of work in EU plant protection regulatory affairs.

I designed this course because I kept seeing the same mistakes made by talented professionals who had deep expertise in one area of the dossier but lacked the cross-disciplinary view to anticipate how dose decisions would affect everything else.

Four hours with this course can save you — or your company — months of rework.

Regulatory Affairs Risk Assessment Plant Protection Products EU Authorisation FOCUS Modelling

Read full bio →

Join the waitlist.
Get early access + 10% off.

This course is launching in 2026. Join the waitlist now and receive early access plus a 10% discount at launch — and be notified as soon as enrolment opens.