 | Iatrogenic transmission of CJD |
Brian Matthews reviews the situation in Europe and discusses the global implications for healthcare manufacturers
BSE/TSE Risk (click to view sample page)
The causative agent of TSEs
The genetic factor
The clinical effect of TSEs
The history of BSE
The properties of TSE agents
BSE and vCJD
| Iatrogenic transmission of CJD |
Effectiveness of various processes against TSE agents
The early impact on the pharmaceutical and medical device industries
Recent developments
| Pharmaceutical sector |
| Medical device sector |
The general approach to data requirements
| Identification of materials of animal origin used in the product or its manufacture |
| Justification for the inclusion of a material of animal origin in the product |
| Information relating to the specific materials of animal origin |
| The method of use of the product, including the quantity of material to which the patient will be exposed |
| The assessment of the data provided |
Discussion and conclusions
Tabulated Annexes (click to view sample page)
References and Information Sources
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