Smets G.,Perseus BVBA |
Alcalde E.,Syngenta |
Andres D.,Bayer AG |
Carron D.,EuropaBio |
And 11 more authors.
Environmental Sciences: Processes and Impacts | Year: 2014
The European Union (EU) Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment requires that both Case-Specific Monitoring (CSM) and General Surveillance (GS) are considered as post-market implementing measures. Whereas CSM is directed to monitor potential adverse effects of GMOs or their use identified in the environmental risk assessment, GS aims to detect un-intended adverse effects of GMOs or their use on human and animal health or the environment. Guidance documents on the monitoring of genetically modified (GM) plants from the Commission and EFSA clarify that, as appropriate, GS can make use of established routine surveillance practices. Networks involved in routine surveillance offer recognised expertise in a particular domain and are designed to collect information on important environmental aspects over a large geographical area. However, as the suitability of existing monitoring networks to provide relevant data for monitoring impacts of GMOs is not known, plant biotechnology companies developed an approach to describe the processes and criteria that will be used for selecting and evaluating existing monitoring systems. In this paper, the availability of existing monitoring networks for this purpose is evaluated. By cataloguing the existing environmental monitoring networks in the EU, it can be concluded that they can only be used, in the context of GMO cultivation monitoring, as secondary tools to collect baseline information. This journal is © the Partner Organisations 2014.
PubMed | SFL Regulatory Affairs & Scientific Communication Ltd and EuropaBio
Type: | Journal: Regulatory toxicology and pharmacology : RTP | Year: 2016
In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label.
Du Marchie Sarvaas C.,EuropaBio
Agro Food Industry Hi-Tech | Year: 2012
Food production and hunger have only recently re-discovered their status as high priority issues. It is widely agreed by international organisations that food production must increase by up to 70 percent by 2050 in order to feed to world's growing population. A wide array of tools and techniques will be necessary to meet this challenge, including biotechnology and other plant science innovations.