Biosafety of GM Crop Plants Expressing dsRNA: Data Requirements and EU Regulatory Considerations

Regulatory and Biosafety Challenges for Vaccines

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product ch...

Gm Crop Cultivation in Ireland: Ecological and Economic Considerations

Like many states in the European Union, Ireland has yet to fully commit itself to genetically modified (GM) crop technology. The general position of the Irish Government is ‘positive but precautionary’. However, with the European-wide de-facto moratorium on commercial production of GM crops now ended, many strategically important decisions regarding the commercial deployment of such crops and t...

Synthetic Biology. Latest developments, biosafety considerations and regulatory challenges

Biosafety considerations for autopsy.

An autopsy may subject prosectors and others to a wide variety of infectious agents, including bloodborne and aerosolized pathogens such as human immunodeficiency virus, hepatitis B and C viruses, and Mycobacterium tuberculosis. Other hazards include toxic chemicals (e.g., formalin, cyanide, and organophosphates) and radiation from radionuclides used for patient therapy and diagnosis. These ris...

Economic aspects and the impact of EU policies on GM crop production, an overview

The Genomic Misconception of Transgenesis is a major source of erroneous decisions in the regulation of GM crops. The difference between GMand non-GM-crops on the level of molecular processes has been overestimated. These misunderstandings grew due of politically motivated fear-mongering. In the wake of molecular breeding, the uncontested understanding among many scientists and in particular fo...