Suchergebnisse

A poster presentation regarding the evolvement of European Union regulations on innovative medicines. Introduction: Innovative medicines in the European Union (EU) must follow regulatory requirements appertaining to the centralised procedure for registration. The study of the evolvement of European regulations on centrally authorised products could shed light on the impact of the regulations on the access to innovative medicines. Aims: To study the impact of the evolvement of European regulations on centrally authorised products (CAPs) on the access to innovative medicines. ; N/A

A poster presentation regarding the simplification of procedures required for registration of medicines. Introduction: A medicine requires a Marketing Authorisation (MA) before it could be made available on the EU market (Directive 2001/83/EC). This registration process ensures the safety, quality and efficacy of medicines on the market. The requirements to obtain a MA are complex and may adversely influence accessibility to medicines. The problem of accessibility to medicines is of particular interest to small countries such as Malta. The availability of high quality medicines that are not very expensive promotes confidence in health systems, health care professionals and the pharmaceutical industry. The research question of this study was: Can registration of medicines in small EU countries such as Malta be simplified? Aims:  To review the processes by which medicines are registered in the EU, with particular interest to small countries  To analyse the strengths and weaknesses of registration processes and identify challenges in the registration process in Malta  To compile a guide intended to simplify the process for the registration of medicines in Malta and in small EU countries ; N/A

A poster presentation regarding a simplified approach for the registration of medicines in small European countries. Introduction: A medicine requires a Marketing Authorisation (MA) before it could be made available on the EU market (Directive 2001/83/EC) to ensure its safety, quality and efficacy. The requirements to obtain a MA are complex and may adversely influence accessibility to medicines. The problem of accessibility to medicines is of particular interest to small countries such as Malta. The research question of this study was: Can registration of medicines in small EU countries such as Malta be simplified? Aims: • To review the processes by which medicines are registered in the EU, with particular interest to small countries such as Malta. • To analyse the strengths and weaknesses of these registration processes and identify problems in the registration process in Malta. • To compile a guide intended to simplify the process for the registration of medicines in Malta and in small EU countries. ; N/A

A poster presentation regarding biosimilars, drug substance quality issues and their impact on the safety profile of biologics. Introduction: Patent expiry of biologics heralded a new category of medicinal products known as biosimilars, approved on the basis of similarity to their reference products. However, concerns exist among healthcare professionals about the quality and safety of biosimilars compared to their reference products. Aims: • To identify and analyse quality issues encountered during development and manufacture of biosimilars' drug substance; • To determine whether the advent of biosimilars in the EU changed the safety landscape of biologics. ; N/A

A poster presentation regarding good distribution practice guidelines. Introduction: An update of the European Union (EU) Guidelines on 'Good Distribution Practice (GDP) of medicinal products for human use' (2013/C 343/01) was published by the European Commission on November 5, 2013. Drug regulation serves to promote and secure public health and well being. Non-adherence to GDP guidelines may lead to an increase in unwanted adverse effects caused by medicines being of poor quality. ; N/A

During the third year of studies, students reading for a Bachelors degree in Pharmaceutical Technology have the opportunity to carry out an eight-week placement at a European university, under the Erasmus programme. During this period, students join research groups in Faculties of Pharmacies in Europe. Students are followed-up virtually during the mobility, by tutors from the sending institution to support them to develop learning skills during the placement. ; N/A