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PDF, Engelska, 2005182 kr
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Essay from the year 2004 in the subject Medicine - General, grade: good, Anglia Ruskin University, language: English, abstract: Select three of the five following areas of research, and identify one ethical issue that is controversial or subject to opposing opinions in each of the three chosen areas. Briefly describe the controversy or opposing viewpoints for these three issues, with reference to the ethical principles or values involved. x Bio-medical research on humansx Pre-clinical research (animal or in-vivo)x Animal health researchx Field studiesx Manufacture, packaging and handling of investigational medicinal productsFor one of the three selected areas, critically evaluate how the applicable laws, regulatory requirements and guidelines address public concerns about the identified ethical issue and the extent to which these achieve a balance between ethical and scientific concerns.
E-bok
PDF, Engelska, 2005182 kr
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Essay from the year 2004 in the subject Medicine - Hospital Environment, Clinical Medicine, grade: good, Anglia Ruskin University, language: English, abstract: For a thorough consideration in the field of Good Clinical Practice (GCP) the first title was chosen:Evaluate how the personnel in key roles in your organisation demonstrate fulfilment of their responsibilities as required by either GMP, or GCP, or GCP(v), or GLP. Propose one improvement in this respect, with a reasoned argument, for each role. With respect to the Standard Operating Procedures (SOPs) of my company, to my employment contract, and to my confidentiality statement I am not allowed to notify third parties of any real or assumed deficiencies within my organisation. Therefore, GCP key personnel and their key functions are identified according to applicable regulations (please refer to Section 7 References). Based on the example of a common German Clinical Research Organisation (CRO) working in the field of Phase I trials duties and fulfilment of responsibilities are discussed. Additionally, only presumed or theoretical deficiencies and their improvement are specified. However, please let me re-emphasise that all facts below are based on regulatory requirements and my experiences but do not allow any conclusions to the operational state of my organisation and to any current or former deficiencies.
E-bok
PDF, Engelska, 2005182 kr
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Essay from the year 2004 in the subject Medicine - Hospital Environment, Clinical Medicine, grade: good, Anglia Ruskin University, language: English, abstract: An accredited laboratory according to ISO/IEC 17025 and a research facility working according to the Organisation for Economic Co-operation and Development Good Laboratory Practice (OECD GLP) series of principles, both facilities perform chemical, analytical and microbiological tests. The main difference is the types of projects that the laboratories deal with. OECD GLP facilities conduct studies for the purpose of testing and assessing chemicals to determine their potential hazards. The GLP principles are a managing tool covering the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Whereas accredited laboratories are testing and calibration laboratories. They operate a quality system, are technically and scientifically competent, and are able to generate technically valid and traceable results. There are many definitions of Quality. One possibility might be to define quality in terms of customer satisfaction . As there is no absolute measure hence it should be management s task to translate future needs of customers into quality products and services]. Therefore a quality system can assist organisations in enhancing customers satisfaction. According to Andrew Waddell there are two dimensions of a quality system, a vertical and a horizontal dimension. The requirements of the vertical, i.e. technical, level are covered by ISO 17025 whereas the horizontal, i.e. managing and organisational, concept is detailed in the OECD GLP principles. However, a comparison of both shows overlapping and/or common requirements in these international standards with unique occurrence in the two of them.
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PDF, Engelska, 200578 kr
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Essay from the year 2004 in the subject Medicine - Other, grade: good, Anglia Ruskin University, language: English, abstract: In 2001, when the Clinical Trial Directive 2001/20/EG was released in the European Union, Article 15 stated the regulations and legislation for government inspections of trial sites to be implemented by the Member States. The competent authorities of the Member States shall verify protection of the rights and welfare of trial subjects, compliance with the provisions of good clinical practice and the quality of data generated in clinical trials by appointing inspectors to inspect the sites concerned with any clinical trial. The European Medicines Agency (EMEA), which needs to be informed about the inspections, shall coordinate them. The inspections are performed on behalf of the European Union; the results should be accepted by all Member States. In Germany, authorisation of inspections is detailed in the German Drug Law and the corresponding GCP ordinance. The BfArM (Bundesinstitut fur Arzneimittel und Medizinprodukte) is the responsible German regulatory authority. The UK competent authority is The Medicines and Healthcare products Regulatory Agency (MHRA). In the US inspections are regulated by the Food and Drug Administration (FDA). The specific instructions for inspecting Clinical Research Organisations (CROs) are given in the Bioresearch Monitoring Compliance Program No. 7348.810. What is an inspection ? The definitions given in the different regulations are very similar. The ICH GCP Guidelines 1.29 [1] state: Inspection : the act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor s and/or contract research organisation s (CRO s) facilities, or at other establishment deemed appropriate by the regulatory authority(ies).