| CODE | PHR5032 | ||||||||||||||||
| TITLE | Qualified Person Requirements: Pharmaceutical Chemistry | ||||||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||||||
| MQF LEVEL | 7 | ||||||||||||||||
| ECTS CREDITS | 5 | ||||||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||||||
| DESCRIPTION | The study-unit presents chemistry principles 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 an identification of the areas required, the unit addresses the compulsory issues required for a Qualified Person. Study-unit Aims: To present aspects of chemistry considered in pharmaceutical product development, production and analysis as related to activities undertaken by Qualified Persons as prescribed in the EU Directive 2001/83/EC. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: • Select adequate chemistry processes for specific synthesis, manufacture and analysis of pharmaceutical preparations within a GMP setting; • Identify chemical principles relevant for the evaluation of processes developed for the synthesis and analysis of investigative medicinal products and medicinal products according to approved marketing authorisation. 2. Skills: By the end of the study-unit the student will be able to: • Apply principles learned 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: - Rang HP. Drug Discovery and Development. 2nd ed. USA: Churchill Livingstone; 2012. - Carey FA, Sundberg RJ. Advanced organic chemistry: Part A Structure and mechanisms. USA: Springer US; 2007. - Carey FA, Sundberg RJ. Advanced organic chemistry: Part B Reactions and synthesis. USA: Springer US; 2007. |
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| STUDY-UNIT TYPE | Lecture | ||||||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Nicolette Sammut Bartolo Claire Shoemake |
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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 2024/5. It may be subject to change in subsequent years. |
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