The demand under European regulations for detailed environmental risk assessment of UCVBs is challenging both the industry and regulators alike. Read on to explore the challenges and possible ways of overcoming them.

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Labcorp Drug Development Blog
The demand under European regulations for detailed environmental risk assessment of UCVBs is challenging both the industry and regulators alike. Read on to explore the challenges and possible ways of overcoming them.
The revised EU GFL (Reg (EC) 2019/1381), or transparency regulation, comes into force on 27 March 2021 and sees changes in the notification of studies, submission of dossiers via IUCLID and the publication of all study reports, to name a few. Read on to find out how these changes may …
Although most physiochemical endpoints are standard for crop and chemical active substances, selection of the right test method to assess them is critical. This blog reviews some standard endpoints and looks at the tests used, in the light of changing regulatory expectations and revised test methodologies for difficult substances.
Leveraging an Integrated, Holistic Solution Small- and medium-sized enterprises typically do not have the resources and expertise to establish an internal pharmacovigilance (PV) operation, as this would divert valuable time and money from product development. As a result, clinical development or regulatory groups, which are not specialized in PV, often …
A compelling model for small and medium-sized organizations in the current EU regulatory landscape Regulatory dynamics in the EU continue to evolve, with higher expectations for pharmacovigilance (PV) as each nation has rigorous and complex patient safety regulations. The shifting landscape represents a unique challenge for small- and medium-sized enterprises …
The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, …
This two-part blog serves to summarize our Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by Medical Device and Diagnostic Solutions through a review of the GDPR …
This two-part blog serves to summarize the Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by our Medical Device and Diagnostic Solutions through a review of the …
The renewal process in the EU and the US for existing active substances requires advance planning and careful and attentive management. Following is practical advice to help you tackle the renewal of your plant protection active substance. 1. Form a Taskforce or Consortium A major difference between the application for …
Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex. The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. Now, even with the all but official postponement of …