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Agenda

Please note: all timings are listed in CEST, to view start times in your local timezone, please click here.

Join us in person or virtually

  1. Coffee and registration

  2. Welcome and introduction by the moderator

    David Dillon David Dillon
    Independent Biocides Expert
  3. SESSION 1: Overviews from the main stakeholders

  4. ECHA updates

    • Updates overview
    • Active substance approval and union authorisation processes 
    Claudio Putzu Claudio Putzu
    Regulatory Officer, ECHA

  5. Review programme extension - implications for innovation, sustainability and industry

    • Arxada AG 
    • BPR implementation to date 
    • Review programme extension and upcoming changes 
    • Implications for innovation, sustainability and industry 
    Carsten Baehr Carsten Baehr
    Director Regulatory and R&D, Arxada

  6. Q&A

  7. SESSION 2A: Impacts of the review programme extension - data protection issues

  8. Importance of data protection for the generation of new scientific knowledge

    • Under the BPR, responsibility for developing scientific data lies with industry 
    • Knowledge and control have increased exponentially, while guaranteeing fairness between players 
    • Article 95(5) BPR on the expiry of data protection for substances still in the review programme destroys this dynamic 
    • Case study of an active substance in the review programme showing how this creates unfair market conditions 
    Antoine Biron Antoine Biron
    Director, TerpeneTech Ltd

  9. Legal update on data protection issues

    • Data challenges from the review programme extension   
    • Pressure testing your data rights strategy  
    • Negotiation strategies 
    Darren Abrahams Darren Abrahams
    Partner, Barrister & Avocat, Steptoe International (UK) LLP

  10. Refreshment break and networking

  11. SESSION 2B: Impacts of the review programme extension - the evaluation process

  12. Experiences with the over conservative evaluation process

    • Introduction
    • Consequences for resources  
    • Consequences for costs 
    • Consequences for timing 
    Ilona den Hartog Ilona den Hartog
    Product Specialist Biocides, Nouryon Surface Chemistry

  13. ED testing – a contract research organisation’s perspective

    • Test strategies for ED 
    • Experience – wave of ED testing for agrochemical active substances 
    • Practical experience and lessons learned when testing biocides 
    Ilse Tonk Ilse Tonk
    Senior Principal Regulatory Toxicologist, Charles River

  14. Q&A for session 2A and B

  15. Lunch and networking

  16. SESSION 3: Other recent developments in the European biocides sector

  17. Annual report tracking trends in the Belgian biocides market

    • Legal framework
    • Situation before October 2022
    • Overview of the current annual report
    • Special focus: Closed circuit of biocidal products
    • Concluding remarks
    Kristof Claes Kristof Claes
    Senior Admin Helpdesk Chemicals & Products, Federal Public Service, Health and Environment, Belgium

  18. New developments in ED assessment from an evaluating Competent Authority (eCA) perspective

    Active substances identified as having ED properties cannot be approved, unless…  New elements:

    • ED risk assessment – precedents from PPP and biocides areas
    • Recent authorities agreements to improve decision-making
    • Changes in the ECHA consultation procedure

    Products containing a substance with ED properties:

    • Regulatory consequences
    • Dossier building and other actions authorisation holders should undertake
    Lucas Kalkers Lucas Kalkers
    Senior Policy Officer, Ctgb, Netherlands

  19. Take aways from a recent competent authority (CA) seminar on best practice for national authorisations

    • Pre-submission meeting 
    • Quantity report 
    Gregor Leonhardt Gregor Leonhardt
    Scientific Officer, Federal Institute for Occupational Safety and Health - Federal Office for Chemicals (BAuA)

  20. First experiences with socio-economic analysis and assessment of alternatives under the BPR

    • Key principles governing derogation dossiers for active substances and biocidal products at EU and national level  
    • Essential use and justification under BPR, Article 5.2 
    • Supporting tools, alternatives analysis outlook, socio-economic analysis and comparative assessments  
    • Experience sharing within different product types  
    • Practical and strategic advice on future submissions 
    Alex Bocquillion Alex Bocquillion
    Partner, EPPA

  21. Q&A

  22. Refreshment break and netwoking

  23. Updates on SPC integration into IUCLID

    • Experiences and challenges during the roll out  
    • Main issues identified after the go-live event in February 2024 
    • Plans for improvement 

    VIRTUAL PRESENTATION 

    Roberto Gilioli Roberto Gilioli
    Scientific Officer – Biocides Assessment Unit, ECHA

  24. Individual Q&A

  25. Networking drinks reception

    Join us for relaxed networking, drinks and appetisers with our speakers and attendees 

  26. Close of day one

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