Agenda
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Registration
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Welcome and introduction by the moderator
- Session 1: Overviews
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EU Commission’s general update on regulatory discussions related to product authorisations
- Modification of Regulation 492/2014 on renewal of authorisations under mutual recognition
- Regulation (EU) No 414/2013 on same biocidal products
- Cancellation of EU authorisations for products containing iodine and/or PVP iodine
- Presence of misleading terms in biocidal products trade names, etc
- Postponement of the active substances review programme beyond 2024
- Renewal of approval of propiconazole for PT-8, etc
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Echa overview
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Member State overview from Denmark
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The BPR – practical implementation and the lessons learned
- Reckitt Benckiser – an introduction
- The fast-moving consumer goods industry (FMCG)
- Practical implementation of the BPR – the FMCG lens
- Moving forward in the right direction
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Refreshment break
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Q&A and panel discussion: What we have learnt from the Covid-19 emergency in the biocides sector and whether there are lessons for the future
- Session 2: The assessment of endocrine disrupting (ED) chemicals under the BPR
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Identification of EDs in ecotoxicology: an overview of available tests
- Overview of in vivo tests for ED assessment in ecotoxicology: strengths and weaknesses
- Identification of endocrine modalities and specific modes of action
- Limitations in determination of mechanistic parameters
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Pepper, a platform supporting the validation process for EDs
- Addressing the gap between academic research and regulatory needs request validation
- Pepper’s work supporting a validation process
- Validation is a common good so resources must be mutualised
Philippe HubertCEO, Pepper, French platform for the validation of methods for characterization of endocrine disruptors -
Q&A
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Lunch
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Chemical Watch demo
- Session 3: Regulatory processes under the BPR
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Lessons learned from the evaluating competent authority perspective on the DBNPA case
- Importance of the representative uses
- Public consultation on alternatives
- Considerations in terms of the derogations
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Developments on derogation dossiers under the BPR: are derogation dossiers becoming the rule?
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The extension of the BPR review programme and its implications for industry
- Current status
- Legislative changes
- Practical impacts (resources, guidance, parallel regulatory developments, market distortions…)
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Preparing for the 2025 deadline, especially regarding data protection issues
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Q&A
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Refreshment break
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Restrictions imposed at active substance level
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The mutual recognition process from the perspective of the coordination group
- Role of the coordination group in mutual recognition procedures
- Procedures and timelines
- Role of applicants in the process and advice regarding actions by applicants
Karolina PastuszkoChief Specialist, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products -
Q&A
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End of day 1