Regulatory services from people who care

2021-12-22

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Mitigation of bottlenecks in ecotoxicological EDC testing capacities

 

Dr. Viktoria Urban (Regulatory Scientific Expert Ecotoxicology at Vali) was one of the speakers at the virtual conference Biocides Europe 2021.

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Her presentation “Mitigation of bottlenecks in ecotoxicological EDC testing capacities“ dealt with capacity issues and challenges of labs for ecotoxicological EDC testing as well as mitigation options for potential bottlenecks:

 

Since 2018 there are scientific criteria for ED applicable for biocides and pesticides. After three years of ED testing in European labs, most labs established level 3 studies, are able to run fish level 4 studies (which are rarely conducted), but are not prepared for fish level 5 and frog level 4 studies. To get a study done, expect 2 years of waiting time.

 

Challenges in the test capacity contain space and equipment of the laboratories. More diluter systems, water capacity and space are often needed, but not every lab can afford this.

There are also challenges concerning test organisms: Fatheads are not available in Europe and are shipped from only a few suppliers in US. A high number of animals is needed and the time to reproduction stage is 4 to 6 months. So, in house-breeding and large breeding capacities are needed.

Another challenge is the fish health: Pathogens in fish are common. So, there is a high risk with each import. Regular controls of fish health are necessary.

Further challenges lie in long-term studies, because there is no data requirement in EU from before 2018. So, only little experience is available. There are also high costs for implementation and lab capacities are already booked up, which complicates establishing long-term studies.

 

To avoid bottlenecks it is important to start early with study preparation, evaluate available data and tailor an appropriate test strategy. If data and substance properties allow, the use of short embryo-based tests might be helpful. To avoid repetition of testing, ensuring health of test organisms and experience of histopathological partner labs are important. Increasing output of studies by setting appropriate test concentrations and considering inclusion of liver histopathology to check for systemic toxicity are an approach. A faster update and development of guidelines as well as realistic validity criteria for the labs in the guidelines could help to avoid bottlenecks.

 

If you need any help or advise for EDC testing, please contact our experts at Vali. Further information about our services for evaluation of potential endocrine disrupting properties can be found here.

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2021-10-06

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Problems with IUCLIDs? Check our services!

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Vali offers services on IUCLIDs like:

 

-        preparation of all relevant dossier parts in IUCLID format,

-        transfer of existing dossiers in IUCLID format,

-        stand alone study summaries,

-        general support on several IUCLID topics

-        and much more.

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For more information, please click here!

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2021-08-25

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Welcome Azahara!

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Vali welcomes our new colleague Dr. Azahara Barra-Jiménez. Azahara is our new regulatory affairs manager for plant protection products and scientific expert in efficacy with a PhD in applied plant biotechnology.

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Azahara is an experienced biologist with background in plant physiology and genetic development. She has 10 years of experience in research where she focussed on applied biotechnology in forest species. Before starting at Vali, she has worked in the regulatory affairs department of a plant protection products company for two years.

 

We are pleased that Azahara is joining the Vali team and wish her a good start.

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2021-07-13

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Do you know KISAR BIOSOLUTIONS?

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Vali is co-founder and main contact of KISAR BIOSOLUTIONS group which is composed by four companies:

Vali Consulting (active ingredients / products registration),

ibacon (GLP services: ecotoxicology, phys-chem, environmental fate),

Clever Bioscience (development from active to formulated products),

GMW Bioscience (EU CRO GLP / GEP field trials, GH under CCC).

 

KISAR offers smart innovative technologies which improve food quality. These technologies ensure food security & public health and are environmentally friendly.

 

KISARs activities include research, development and registration of biopesticides, biostimulants and hybrid PPP formulations.

 

The projects can be managed from their idealization to market authorization, passing through important processes such as: discovery, development up to industrial process for actives and formulations, efficacy trials, dossier preparation and submission.

 

A more comprehensive information on KISAR is provided under:

www.kisarbiosolutions.com and https://www.linkedin.com/company/kisar-biosolutions

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For further information don’t hesitate to contact Dr. Saúl Molina-Herrera.

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2021-05-21

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Welcome Frédéric!

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Vali welcomes our new colleague Dr. Frédéric Brunner. Frédéric is our new regulatory affairs manager for biostimulants with a PhD in biology.

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Frédéric is an experienced biologist/biochemist with a background in molecular phytopathology, plant biochemistry and plant physiology. Before starting at Vali, he has worked as chief scientific officer in a Spanish company in the agricultural biologicals market where he gained experience with the registration of plant biostimulants.

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Furthermore, he has worked for many years in academic research on plant immunity with a strong focus on microbe sensing, signalling and defense activation, acquiring strong knowledge in mechanisms underlying plant protection.

 

We are pleased that Frédéric is joining the Vali team and wish him a good start.

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2021-05-10

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Welcome Viktoria!

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Vali welcomes our new colleague Dr. Viktoria Urban. Viktoria is our new regulatory scientific expert on ecotoxicology and endocrine disruptors with a PhD in natural sciences.

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Viktoria is an experienced ecotoxicologist with a background in aquatic ecotoxicology, molecular ecotoxicology and endocrine disrupting properties. Before starting at Vali, she has worked in the aquatic department of a contract research organisation where she was the team leader for fish and endocrine testing.

 

Furthermore she has worked several years in research with the focus on biomarker identification for endocrine disruption in fish.

 

We are pleased that Viktoria is joining the Vali team and wish her a good start.

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2021-03-16

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Biocides in UK/Resubmission for ongoing applications

 

With regard to Brexit the United Kingdom has implemented its own system to regulate biocides.

As a consequence, as of 1 January 2021 UK has no longer access to EU IT systems such as R4BP3, thus, it is no longer posssible for UK authorities to access ongoing applications in the EU and the respective data sets.

If you want to know more details, click here.

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2021-03-08

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Welcome Ana!

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Vali welcomes our new colleague Dr. Ana María García Carril. Ana is our new regulatory scientific expert on physical /

chemical properties and analytics with a PhD in Chemistry.

 

Ana is an experienced organic chemist with a background in synthesis of organic molecules, molecular recognition and combinatorial chemistry. Before joining Vali, Ana worked as a regulatory expert for ten years for the Spanish Authorities (INIA) in the registration of plant protection products at EU level and for the Spanish Agency of Medicines in the registration of veterinary medicines.

 

Furthermore, Ana worked for a consultancy for nearly 2 years where she gained experience with the registration of Biological Plant Protection Products.

 

We are pleased that Ana is joining the Vali team and wish her a good start.

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