Product quality and compliance in the pharmaceutical industry

This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Assurance Department until today in the currently named Product Quality & Compliance department. This thesis is structured into 4 parts. The first chapter is an introduction to this thesis, and includes its context and objectives, followed by a brief overview of the state-of-the art in the pharmaceutical industry, including the market environment, the regulatory environment and quality requirements. A small presentation of the company and the department where were and still are developed my professional activity is also made in this chapter. In the following chapter are described the main tasks performed, the complementary activities and key skills acquired throughout this professional experience. A discussion and conclusion is presented at the end, including an analysis of the reported activities, main difficulties encountered its role and importance in the company performance as well as the skills acquired during this work experience.

Curricular training report: pharmaceutical industry & spin-off company

O presente relatório expõe as atividades desenvolvidas durante o estágio curricular, frequentado na Bluepharma - Indústria Farmacêutica S.A. e na TREAT U, Lda. uma Spin-off da Universidade de Coimbra, no âmbito do Mestrado em Biomedicina Farmacêutica da Universidade de Aveiro. Esta foi uma experiência de 6 meses que teve duas componentes, uma multidisciplinar e outra monodisciplinar, as quais me permitiram desenvolver os conhecimentos e aptidões adquiridas ao longo do curso de mestrado e de as aplicar ao mundo real. Para além do desenvolvimento de competências profissionais, esta experiência possibilitou também a aquisição e desenvolvimento de várias aptidões, quer a nível pessoal como social. Nos primeiros dois meses desta minha experiência adquiri um conhecimento essencialmente teórico em várias áreas da indústria farmacêutica (financeira, desenvolvimento de negócio, assuntos regulamentares, investigação e desenvolvimento de medicamentos, garantia da qualidade, etc.) através da minha passagem pela Bluepharma. De seguida, na minha experiência de quatro meses na TREAT U, foi-me dada a oportunidade de realizar de forma mais independente, as funções inerentes ao cargo de assistente da gerência, com especial enfoque para atividades de gestão de projeto (incluindo assuntos regulamentares), tais como, apoio na preparação do plano de desenvolvimento não clínico e na preparação do pedido de aconselhamento científico. Este relatório começa assim por descrever os objectivos do estágio e uma breve descrição das instituições que me acolheram para a sua realização. De seguida, os conhecimentos adquiridos na vertente multidisciplinar do estágio e depois as atividades desenvolvidas no âmbito monodisciplinar. Por fim, apresenta uma análise das dificuldades e desafios encontrados bem como os esforços realizados para os ultrapassar.

Avaliação em contextos de blended learning no ensino superior

The increasing complexity of the Information Society and the Bologna Declaration in the European context has led Higher Education (HE) institutions to revise their curricula courses, as far as the adoption of new strategies for teaching and learning as well as evaluation are concerned. It can also be emphasized that there has been a growing use of eLearning and of blended learning (bLearning) in HE, since these modes of training seem to be a very convenient option for lifelong learning. In this context, quality is taken as an essential goal in the development of the European Space for Education and Training, where HE institutions compete among themselves, and where evaluation is determinant as a promoter of this quality. Considering the problems summarized above, the research developed, based on four published scientific papers, intended to answer a set of research questions related to evaluation of bLearning contexts in HE. The study used diverse techniques and instruments (questionnaires, document analysis, and observation mediated technologies) spanning two methodological approaches: i) study of descriptive and exploratory nature and ii) case studies of bLearning modules. In the first approach an evaluation model for bLearning courses was developed, where we collected and analyzed, at a national level, the opinions of teachers with bLearning experience about the model dimensions. The case studies presented are post graduation curricular units, where bLearning teaching, learning and evaluation strategies were explored and evaluated, namely peer assessment. The main contributions of the first approach are: the process of questioning around the evaluation of bLearning courses, namely the quality assurance criteria for bLearning, as well as the model developed, providing a framework of theoretical, methodological and empirical elements that can be adapted in similar contexts. From the case studies emerged: the developed evaluation guidelines and the data collection instruments, in order to disseminate evaluation “best practices” that may be useful for other units in similar contexts. Regarding the recommendations about the evaluation of teaching of bLearning courses we emphasize: the use of versatile evaluation objects; the evaluation throughout the process and not just at the end; and the involvement of multiple evaluators, including students (whose feedback is essential to monitor the quality of teaching and learning). From the case studies we highlight: the need for discussion of evaluation frameworks to explore, and consequent increase in the transparency of the evaluation process; the increased interaction between groups; and the peer assessment as a strategy to promote active and autonomous learning. In addition to the contributions and recommendations for practice and research in the area of evaluation in bLearning contexts in HE, listed above, it also emerged from this study useful guidelines regarding educational evaluation in bLearning contexts, in order to improve the quality of teaching, learning and evaluation in such contexts.