Master's Thesis from the year 2004 in the subject Health Science, grade: sehr gut, University of Bonn (Mathematisch-Naturwissenschaftliche Fakultat), 116 entries in the bibliography, language: English, comment: Abschlussarbeit Postgraduiertenstudiengang "Public Health" der Universitat Dusseldorf, abstract: Malaria as a disease of the poorest in the world is on the global agenda. Many different groups take efforts in order to tackle malaria. Facing the fact that mainly children and pregnant women present the biggest problems it is difficult to maintain a logical way in order to improve the malaria situation. Therefore, organization and coordination of the efforts is an area of improvement. For example, various Public Private Partnerships have partly identical missions (e.g. GAVI and MVI), and there is good reason for combining their efforts and save administrative resources. The first step in a logic chain should be to provide better diagnostic features for the correct detection of malaria with the consequence of an adequate treatment. Country surveillance programs need to be set up in order follow resistance patterns, treatment effects, demographic patterns etc. In parallel better therapeutic and preventive measures need to be developed in order to win the race against resistance of vectors as well as parasites. All these efforts need to be planned, coordinated, managed and regulated. This requests one global coordinator with an "umbrella function" that defines rules for all partners involved and manages the cooperation. The umbrella function should sit within a non-profit organization with long-term experience in the field, in other words the UN and more precisely the WHO. Cooperating partners can be of very different origins like industry, governments, private and public foundations, NGOs, etc. Many of these organizations already exist, but their efforts are partly the same, some themes are left out the scope. Therefore, the general recommendation wou

Master's Thesis from the year 2004 in the subject Health Science, grade: sehr gut, University of Bonn (Mathematisch-Naturwissenschaftliche Fakultat), 24 entries in the bibliography, language: English, abstract: The Regulatory Affairs (RA) department is a key discipline in the global network of drug development. During drug development, regulatory strategy is one crucial success factor for the approval of the development candidate. Also, regulatory strategy can optimise labelling in the key countries in order to maximise the market success. No submission and approval would be possible without the appropriate dossier composition and compilation. Without adherence to the respective guidance documents and scientific advice from Health Authorities to design the optimal clinical development plan, optimal labelling would not be feasible. These two examples show some characteristics of the regulatory strategy: it is highly interactive with other disciplines and it is heavily based on a thorough intelligence work which enables the RA Manager to know the "rules of the game" and to develop the optimal regulatory strategy for the current development candidate. The major cornerstone for developing a regulatory strategy is regulatory intelligence. This document focuses on regulatory intelligence. The regulatory contributions to the global drug development from early research to submission are described. Strategies for generic drugs as well as detailed strategies for life-cycle management are excluded. Major components of regulatory intelligence are: Competitor Information Information on Regulatory Environment Information on Legal Requirements Competitor analysis is an essential aspect of the intelligence work. Sources of competitive information as well as relevant items of competitive information are described. Sources of information about the regulatory environment and sources of information about the legal regulatory environment are described and their tremendous impact