We need well designed clinical trials in order to manage different health issues and deliver quality vaccines and drugs to patients. The whole process starts with the phase I of the trial, followed by phases II and III, after which the documentation is presented to the regulatory body, which reviews the data presented, going into the phase IV if required. The process ends with a license to market being issued. Trials are expensive, time consuming and with uncertain outcomes. The old ways of managing clinical trials do not give satisfactory results any more. It seems that the change is needed more than ever before. Clinical research organizations that manage clinical trials, being a part of a highly innovative industry, need innovation themselves. They need to adapt in order to stay competitive. In this paper, it is presented, according to the literature review, that a possible way to undergo adaptation is through agile transformation.
Current Good Manufacturing Practice (cGMP) being a legal regulation in developed countries will become a legal regulation in Republic of Serbia starting with March 2010. In this paper comparative analysis between requirements of standard ISO/IEC 17025 and requirements of cEU GMP is shown. Considering the fact that in Republic of Serbia no pharmaceutical industry laboratory has been accredited according to requirements of ISO/IEC 17025, while keeping in mind that more than 90% of these laboratories have not fulfilled cEU GMP requirements, this paper aimed at pointing to the possibility of fulfilling both of mentioned requirements at the same time, which would open the way to different types of interlaboratory cooperation for pharmaceutical quality control laboratories and contribute to improving competitiveness of pharmaceutical companies. Accreditation, especially in the case of pharmaceutical quality control laboratories, is important because it guaranties the level of organizational and technical competency. It could easily be said that accreditation is becoming a must in quality control of products in order for the organization to be able to gain a leading role in the global market. Both accreditation and cGMP show the organization's commitment to having products of highest quality level. Considering the above mentioned facts, it is of greatest advantage for pharmaceutical quality control laboratories to fulfill both requirements of ISO/IEC 17025 and cGMP and reach total compliance. The aim of doing this lies in an easier acceptance of pharmaceutical products in different markets, overcoming technical barriers and affirmation of quality as key factor in reaching competitiveness, while keeping in mind the importance of strategic and competitive positioning in the global market
Modern management plays a major role and is relevant in the field of sustainable development, since its applicable knowledge contributes to improving the overall atmosphere of a society. In the development of a country, a society based on effective knowledge is important, as well as on the concept of sustainable development. The concept of sustainable development contributes to the improvement of learning and the establishment of social values based on the knowledge and skills of human resources. Thus, there is a need for planned education and the creation of quality management in order for society to slowly move towards the concept of a learning society. In this sense, the aim of this paper is to examine the extent to which a higher education institution can contribute to the above. The research was conducted at the Educons University, Faculty for Project and Innovation Management PMC in Belgrade. On that occasion, it was concluded that the mentioned faculty is an example of good practice in how to educate young people to think about the future and become managers who adhere to the concept of sustainable development. This paper is intended primarily for leaders of higher education institutions in order to gain some insight into aspects of this topic, as well as students to gain more knowledge about the concept of sustainability implemented in educational institutions, and then the general public.
Inovacije imaju sve veći značaj u savremenom poslovanju, do mere u kojoj postaju nezamenjive kada se radi o digitalnim tehnologijama. Sve je brži rast broja korisnika digitalnih tehnologija, i on ide uporedo sa njihovom sve većom dostupnošću, tako da je činjenica da dolazi do njihove brze evolucije. Posmatrano u tom kontekstu, sve je veći i značaj menadžmenta u okviru kompanija koje se bave ovakvim vidovima delatnosti. Brza evolucija IT sektora može se primetiti kada se radi o Internetu, kao nezamenjivom sredstvu komunikacije u savremenom svetu. Masovna je primena digitalnih elektronskih kompjutera, a posebno ličnih i mobilnih kompjutera. Poslednjih nekoliko godina dolazi u još većem obimu do korišćenja i drugih uređaja neophodnih kao sredstvo komuniciranja u digitalnoj tehnologiji. To se prvenstveno ogleda u činjenici da je došlo do naglog povećanja broja korisnika Interneta koji Internet ne koriste preko ličnih računara, već preko tableta i pametnih mobilnih telefona. Savremene aplikacije i multifunkcionalnost savremenih mobilnih telefona utiču pozitivno na ovaj trend. Kao posledica, ovakve
Telecommunications have become highly important for the successful business operations of almost every organization in the world, in the public and private sector, and is the core of most multinational companies' businesses. Telecommunications are an integral part of the global communications network; they are critical for organizations as well as for individuals and have socio-economic value. Large telecommunication companies are doing business in an environment where there is a discrepancy between the need for the introduction of innovations into the portfolio of services and the traditional methods of service development, as well as their market placement. With the expansion of the internet in the industry, the ways of distribution and consumption of digital services have changed considerably. Taking into consideration the increasing complexity of regulations and the environment in which projects that support the development of ICT products and services are led, the right choice of project management methodology is becoming more important. Alongside with the usage of traditional approaches to project management, there is a development of new methodologies through the introduction of dynamic models for achieving project results more quickly. This thesis is based on research conducted on a telecommunications company representative in the region, with the assumption that the introduction of agile methodologies can achieve competitiveness in the highly competitive market of modern telecommunications services. The presented results are based on research conducted in the large telecommunications company, with an emphasis on the recognition of requirements for the introduction of different project management methodologies in the service development process. Based on surveys of management and employees of the company that is involved in the process of service development, test and agile management have been introduced along with the existing traditional management. This paper shows a comparison between these two methodologies on one project which includes the introduction of an innovative ICT service. Based on the results, the hypothesis which assumes that the introduction of agile management provides competitiveness on the market of telecommunications services has been confirmed.
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