Apr. 20, 2018
Managing Director of Eurofins Regulatory AG
Following his appointment in September, 2017, Vincent Dreze has been pivotal in developing and shaping the in-house group of regulatory experts at Eurofins Agroscience Services (EAS). Here, we share some of the questions that Vincent has been asked by the industry regarding the current capabilities of Eurofins Regulatory AG, his responses and future plans…
Understanding you provide regulatory support for product development, what range of support can you offer?
Basically for any, conventional pesticide, bio-pesticide or biocide, EAS can cover the full spectrum; from molecule-screening through to post-submission follow up with authorities for both actives and formulated product dossiers.
How does EAS handle any issues arising during active projects?
The Project Management system in place at EAS has a specific emphasis on issue management. There is a formal issue reporting process. The main focus is that when an issue pops up, EAS gets back ASAP to the client with a thorough analysis of the situation considering any potential impact on the project and possible solutions to the issue– transparency and pro-activity are key to the way we operate.
How can EAS support a client with regards to their portfolio management research?
EAS is now finalizing its offer of initial “risk forecast” for actives supporting customers in their decision-making process concerning portfolio management. This may also include comparison with non-proprietary substances of the customer if feasible based on publicly available information.
What is the position of EAS with regards to EFSA’s impact on regulatory decisions?
EFSA is the Authority according to the Regulation 1107/2009. In that respect their impact is significant. For some time, stakeholders have noted that despite positive outcomes from thorough assessments being carried out by the Rapporteur Member State supported by the experts from the other Member States, EFSA can take a completely different decision and either propose “non-inclusion” or at least identify an extensive list of data gaps/open points to be addressed in the product re-registration phase.
Very recently at the annual European Regulatory Conference organized by the European Crop Protection Association, industry was engaging into a conversation with EFSA about the possibility to get pre-submission meetings with EFSA. Such pre-submission meetings as the ones already taking place between industry and the Rapporteur Member State may provide more clarity about expectations and then limit the uncertainties linked to the outcomes of the peer-review process.
How long does it take to carry out a test from date of quote request up to study report finalization?
It depends on the study in question but indications on timeframe from study initiation to final report issuance date are captured in EAS quotes provided to the customer; quote turnaround is quick, between 2 and 7 days provided the study design is clear. For EAS customers it is crucial that we do deliver high quality reports and dossiers in a timely manner to meet both authorities and industry’s deadlines.
Do you have experience with IUCLID entries preparation?
Yes - our Biocides Team in the UK is accustomed to this.
Regarding your experience in waivers preparation; has EAS been successful?
Expert statements are the ordinary tool and successful as long as they are based on a justified scientific and regulatory position. Normally, we do not take a position we are not able to defend!
EAS regularly prepares expert statements for waiving of studies – these are provided by regulatory experts with significant experience and enjoy a good success rate.
What is the capacity of EAS Regulatory AG to handle Art 43 dossiers?
Art 43 dossiers form the majority of our daily work. The capacity to handle a complete re-registration package for products based on a renewed a.i. depends very much on the number of products and target countries concerned.
Does EAS Regulatory AG have the ability to handle completely outsourced dossiers?
Yes - EAS Regulatory AG works on full registration projects, i.e. data gap analysis, study condition/ study monitoring, dossier preparation and post-submission follow up for active substance renewals and subsequent product re-registration dossiers and is therefore capable of handling completely outsourced projects. Usually EAS delivers the dossiers for product re-registration to client however submission directly to authorities is also possible.
EAS is committed to matching the ability and capacity of the regulatory team to address the clients’ needs for larger product registration programs including the submission of dossiers.
Do you have automated tools to limit the risks of reporting issues from studies to regulatory dossiers (study summaries)?
This actually takes place for the biological dossier and for environmental fate modeling reports. That said, each dossier is unique and requires expert judgment which is peer-reviewed before dossiers are sent to the client.
Does EAS have experience with search and assessment of monitoring data?
We have recently worked on a renewal dossier to provide an assessment of all publically available monitoring study results from all Member States. So far this has not been a standard request – but it is something we can offer based on the individual expertise of some of our team members.
If you have any questions on this Q&A, or would like further details on Eurofins Regulatory AG – please contact Vincent Dreze