Nov. 15, 2019
To meet the increasingly challenging needs of effective and informative chemical risk assessments, and especially in the context of higher tier assessments, RIFCON GmbH prides itself on the well-established effect modelling and statistics team. This team can meet the typical demands that involve information technology and computational and often nonconventional yet scientific approaches. It encompasses versatile expertise in computer programming and scripting, model development, testing, documentation and application as well as basic and advanced statistics and data analysis approaches.
In service of submissions for active substances and (re-)registrations of plant protection products, the effect modelling activities cover both Toxico kinetic-Toxicodynamic (TKTD) and population modelling. This team of skilled scientists also provides basic and statistical data analysis to support the design and interpretation of laboratory, semi-field and field studies, in addition to process automation and data visualisation. At RIFCON GmbH, various departments closely cooperate. In this context, the effect modelling and statistics projects are performed in cooperation with the ecotoxicology and the field teams, allowing the provision of comprehensive customer support. The relevant teams get involved in pre- and post-submission meetings to explain (planned) approaches and get feedback on approval of approaches, wishes for modification/improvement as well any open questions that might arise. Additionally, RIFCON GmbH has its own IT department that can devise any tailor made technical solutions, for instance web server applications.
The effect modelling activities at RIFCON GmbH are well in line with the European Food Safety Authority’s (EFSA) scientific opinion on good modelling practice in the context of mechanistic effect models for risk assessment of plant protection products, issued in 2014. The specialized team actively seeks to implement the suggested aspects and to improve their implementation based on experience and feedback. Since neither guidance nor generally agreed models are yet available, and since problem solving can be approached in a multitude of ways, it is noteworthy to highlight here that RIFCON GmbH provides the ideal context for such modelling activities. At RIFCON GmbH, the strongly interlinked specialist teams work together to address the formulated problems while benefitting from the crucial versatile viewpoints, expertise, skills and insights. A major aspect of this team-play is the keenness of skilled members on devising and improving target-oriented approaches and incorporating the latest knowledge.
RIFCON GmbH owns a set of effect models that are used in European registration processes. These models were developed and documented within the company and are being actively maintained and improved there as well, via the ample experience, which is continuously gained from investigations and actual applications in the context of risk assessment. It is also an option at RIFCON GmbH to use other externally established models when available and needed, and to get in touch with the developers for inquiries or special needs. The development of additional models to support recurrent pesticide risk assessment questions is also an ongoing activity at the company and can be undergone upon request as well.
The aforementioned team of skilled scientists provides support in the area of statistics and data analysis to support the design and interpretation of laboratory, semi-field and field studies, in addition to process automation and data visualisation. Descriptive and inductive statistics for field and laboratory studies are among the team’s expertise, ranging from simple hypothesis testing to advanced analysis using generalised linear or additive (mixed) models. The team typically evaluates or re-evaluates existing study data and performs additional calculations for existing studies. Investigations on minimal detectible difference (MDD) and effect concentrations (ECx) following existent guidelines are two examples. Statistical consulting and expert statements are part of the team’s portfolio, in addition to tailor-made solutions for data processing, analysis and visualization and process automatization.
RIFCON GmbH in principle strives for transparency and promotes information exchange, as it is crucial to actively get insight and interchange viewpoints with various parties including academia, industry and member state authorities on the expectations and quality of deliverables as well as the emergent needs and recent developments. To facilitate and provide a communication platform with interested parties, the effect modelling and statistics team conducts training workshops on effect modelling including TK-TD, population modelling as well as output analysis approaches, presentation and communication. The team tailored several workshops in the past couple of years to meet the needs and requests of customers, in addition to public workshops. RIFCON GmbH is keen on sustaining this enriching practice while holding the state-of-the-art activities and applied investigations as the workshops’ fundament. The committee of the Society of Environmental Toxicology and Chemistry (SETAC) Certification of Environmental Risk Assessors Programme evaluated the contents of the aforementioned workshops, and accordingly approved the past and upcoming workshops as valid courses under this programme.
Generally, RIFCON GmbH welcomes challenging and new ideas and endorses experienced and enthusiastic personnel to explore new possibilities and put them into action.
This article was initially published in AgroPages '2019 CRO & CRAO Manual' magazine. Download the PDF version of the magazine to read more articles.