You are a senior business development manager of a biopharmaceutical company and you are seeking board approval for the acquisition of a drug candidate that has been developed in an EU Member State. More
The advantages genetics could bring to clinical development and decision-making, as well as the next steps needed to make it a valid tool in this environment, were underscored in the recent findings of two studies by research groups at Harvard More
Regulatory documents that address clinical biotherapeutics such as monoclonal antibodies and recombinant DNAderived proteins are written in broad generalities to accommodate variability in the types of products, patient populations, dosage, and produ More
Human cloning and stem cell research issues had been at the forefront of global debate until 11 September 2001. Since then, a proposed UN treaty on human cloning has been shelved repeatedly and is unlikely to be debated again before the end of 2003. More
This is the third issue of the series providing a regular review of the latest legal developments as they impact on the pharmaceutical and healthcare sector. More
The European Commission's attempt to harmonise the rules and procedures for clinical trials throughout the EU was finally adopted on 14 December 2000. More
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