| CODE | PHR5012 | ||||||||
| TITLE | Qualified Person Requirements | ||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||
| MQF LEVEL | Not Applicable | ||||||||
| ECTS CREDITS | 5 | ||||||||
| DEPARTMENT | Pharmacy | ||||||||
| DESCRIPTION | The study-unit presents the areas required to be covered by candidates aspiring to seek approval to practice as a Qualified Person in the pharmaceutical industry. From a gap analysis to identify areas required, the course addresses the compulsory issues required to practice as a Qualified Person. Study-unit Aims: To present areas related to medicinal product development and production within the parameters of quality and regulatory obligations that are essential for candidates aspiring to practice as a Qualified Person in the pharmaceutical industry. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student would have identified and acquired academic requirements as prescribed in the EU Directive 2001/83/EC, Article 49. 2. Skills: By the end of the study-unit the student will be able to: By the end of the study-unit the student will be able to: - Apply principles and requirements of Good Manufacturing Practice and Good Pharmacovigilance Practice to practical scenarios in processes undertaken within the pharmaceutical industry; - Carry out batch release of medicinal products and investigational medicinal products to the European Market or for clinical trials. Main Text/s and any supplementary readings: - MHRA. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015. Pharmaceutical Press. - EU. Eudralex. The rules governing medicinal products in the European Union. 2014. |
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| STUDY-UNIT TYPE | Lecture and Tutorial | ||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Nicolette Sammut Bartolo Maresca Attard Pizzuto |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2023/4. It may be subject to change in subsequent years. |
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