Biocontrol: Navigating the EU Regulation for Microbials

This training focuses on the specific regulatory challenges of microbial active substances. It covers key data requirements, the use of waivers and EFSA guidance, and the practical realities of preparing robust IUCLID dossiers and draft Registration Reports.

OverviewProgrammeSpeakersVenuePrices & Services

Overview

Microbial biocontrol products present some of the most scientifically complex cases in EU regulation. As living organisms, they require a fundamentally different approach – from strain-level identification and metabolite assessment to the evaluation of infectivity, pathogenicity and environmental behaviour.

Designed for professionals working with microbial solutions, this course helps you understand what makes microbial assessments unique – and how to translate complex biology into a compliant, convincing regulatory submission.

Deliverables:

  • Step-by-step understanding of EU regulatory procedures for Microbials
  • Actionable guidance on data generation and dossier compilation
  • Expert tips to streamline approvals and reduce regulatory delays

Who should attend this meeting?

Sectors that should take part:

  • Chemical industry
  • Biopesticide and biocontrol developers and producers
  • Startups and small and medium-sized enterprises developing biocontrol products
  • Regulatory affairs

Professional groups:

  • Academic Researchers aiming to translate lab findings into regulatory submissions
  • Industry Experts transitioning to or supporting biocontrol solutions
  • Regulatory Affairs Specialist and consultants expanding into the biocontrol space

© Picture Credit: ttsz – iStock (Modified with AI)

 

Programme

PLEASE NOTE: The indicated times refer to Central European Time Summer CEST.

For further time zones, please view here.



Thursday, 23 July 2026


09:00 – 13:00 | CEST
1. General introduction to regulatory affairs for plant protection products
Active substance approval and productauthorisation in EU
  • Involved authorities
  • Time lines
  • Data requirements for a.s. and products in general
  • Renewal
  • Low risk/Biocontrol (Omnibus proposal)
  • Risk assessment
2. Microbial Active Substances – Scientific & Regulatory Specificities in the EU
Identity and characterisation of microorganisms
  • Strain-level identification,
  • Metabolite assessment and antimicrobial resistance
  • Biological properties and mode of action
Specific data requirements for microbials
  • Human health: infectivity, pathogenicity, toxigenicity
  • Environmental fate and behaviour
  • Residues
Regulatory guidance and key EFSA documents for microbials
  • Use of waivers and scientific justification
Dossier preparation in practice
  • IUCLID challenges specific to microorganisms
  • Common pitfalls in dRRs

Speakers

Name

Company

Sarah-Madeleine Hönig

Knoell, Germany

Sarah-Madelein Hönig is Senior Manager Biocontrol, Global Regulatory Affairs for crop protection at Knoell Germany with over 10 years of experience in regulatory consulting for both biocides and plant protection products.

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Milena Stephan

Knoell, Germany

Milena Stephan is te Team Lead Regulatory Affairs Biocontrol at Knoell Germany. She has previously worked as Regulatory Affairs Manager at SCC and holds a PhD un biophysical Chemistry from Georg August Universität Göttingen

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Venue

Online Training
This training is going to be held online.
You can reach us directly at:
Phone : +49 231 75896-50
Email: info@akademie-fresenius.de
www.akademie-fresenius.de

Prices & Services

Participation Fee: € 645.00 plus VAT.

The registration fee includes the following benefits:

  • Participation in the Online Event
  • Certificate of participation
  • Training documentation (available after the training via download from our website)

Representatives of an authority or a public university are therefore eligible for a reduced fee of € 495.00 plus VAT per person (please provide evidence). The reduced fee cannot be combined with other rebates.

Group Reductions
For joint bookings received from one company we grant a 15% discount from the third participant onwards.

Terms of Cancellation / Book without Risk
You can cancel your participation in our online events free of charge and without giving reasons in writing up to 1 week before the start of the event. In the case of later cancellations and non-login to the online event, no participation fees can be refunded.
In this case, however, you will receive access to the documentation after the event.
You can name a substitute participant free of charge at any time.

Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoeller@akademie-fresenius.de

Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoeller@akademie-fresenius.de

Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoeller@akademie-fresenius.de

Jennifer Zerth

Your Contact

Jennifer Zerth
Organisation and participant management

+49 231 75896-79
jzerth@akademie-fresenius.de

Jennifer Zerth

Your Contact

Jennifer Zerth
Organisation and participant management

+49 231 75896-79
jzerth@akademie-fresenius.de

Display / Supplement

Present your Company at the Event.

You can personally present your products and services directly to your specified target group. We are happy to provide you with further information on our range of available options – from displaying company information at the reception counter to presenting your company with an exhibition stand.

We would be pleased to assist you personally:

Monika Stratmann

Monika Stratmann
Phone: +49 231 75896-48
info@akademie-fresenius.de

Press Contact

We offer journalists and editors a platform where they can get in touch with the experts.

If you are the editor of a specialist publication and interested in a press pass or media partnership, please contact us well in advance. We are happy to advise you.


Please contact us:

Katharina Geraridis

Katharina Geraridis
Phone: +49 231 75896-67
presse@akademie-fresenius.de