OAR@UM Community: /library/oar/handle/123456789/39180 2025-12-23T07:50:24Z The roles and responsibilities of the Qualified Person in the pharmaceutical industry /library/oar/handle/123456789/13948 Title: The roles and responsibilities of the Qualified Person in the pharmaceutical industry Authors: Pisani, Rachel Cilia; Vella Brincat, Gabrielle; Farrugia, Claude Abstract: Malta’s accession into the European Union in May 2004 brought with it a number of changes within the local pharmaceutical industry. Foremost amongst these was the requirement for the holder of a manufacturing or import authorisation to have permanently and continuous at his disposal the services of one or more Qualified Persons (QPs). 2009-01-01T00:00:00Z The European Court of Justice on the liberalisation of community pharmacy services /library/oar/handle/123456789/13947 Title: The European Court of Justice on the liberalisation of community pharmacy services Authors: Buttigieg, Francesca Abstract: Today EU citizens are becoming increasingly aware of Infringement procedures initiated at the European Court of Justice regarding several and varied issues. Community pharmacies around the European Union are not an exception, and have also been the subject of certain infringement proceedings. 2009-01-01T00:00:00Z Food-drug interactions : do they really matter? /library/oar/handle/123456789/13946 Title: Food-drug interactions : do they really matter? Authors: Vella, Valerie Abstract: In pharmacists’ daily practice, particularly when advising patients regarding their dosage regimen, they are often faced with the recurring question “do I need to take this after a meal?” Sometimes it makes one wonder whether this is a true concern or whether it is just an excuse to eat! The truth, however, is that interactions between food and medicines can have a significant influence on the adverse effect profiles of many drugs and on the therapeutic success of the drug being administered. 2009-01-01T00:00:00Z Biotech drugs : biological therapeutic agents /library/oar/handle/123456789/13926 Title: Biotech drugs : biological therapeutic agents Authors: Grech, Godfrey; Fenech, Anthony G. Abstract: The recent years has seen significant growth in a new therapeutic approach to the management of disease. Biological therapeutic agents, constitute a broad category of drugs, usually generated by recombinant techniques from living organisms. These therapies revolutionise the traditional approaches to drug design and development, and regulatory agencies have been swift in developing the necessary structures to ensure their optimal use. 2009-01-01T00:00:00Z