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This two-year distance learning course has run successfully for 20 years. It is intended for graduates in the pharmaceutical industry who wish to satisfy the EU educational requirements concerning the Qualified Person responsible for the manufacture of human and veterinary medicinal products. Over 300 students have successfully completed the course, many of these now hold global or senior executive quality management positions in pharmaceutical multinational companies.
Acceptability of the course
Diplomates of the course are recognised by EU regulatory authorities as having satisfied the educational requirements in respect of the academic training necessary for registration as a Qualified Person. Successful completion of the course does not guarantee recognition as a Qualified Person as the granting of such status is the responsibility of the Pharmaceutical Regulatory Authority (Irish Medicines Board in Ireland). They reserve the right to accept or reject any candidate for registration according to their judgment of a candidates suitability and industrial experience.
Applicants with a three-year primary degree and industrial experience must qualify with an M.Sc. but applicants with a four-year primary degree are only required to complete the Diploma programme.
The course is a two year distance learning course running from January to December each year, comprising of nine modules with parallel assignments per annum.
The general areas covered are:
* Pharmaceutical,
* Medicinal & Analytical Chemistry,
* Pharmaceutical Processing, and Drug Action,
* Uses and Assessment.
Participants must also undertake a number of manufacturing facility visits and there is a requirement for limited attendance at the School of Pharmacy for practicals, workshops and regulatory lectures. The course schedule is designed to accommodate students travelling from abroad - recent international graduates include students from Singapore and California. Candidates who are eligible and wish to progress to the M.Sc. must undertake an industrial practice dissertation. These dissertations require an extensive literature review followed by experimental work or data acquisition and subsequent analysis of data that has been generated by the student.
The School recognises that applicants may, by virtue of academic background and industrial experience, be familiar with the contents of one or more of the modules. Requests for exemption are invited after the issue of modules from suitably qualified students and the academic responsible will review each case individually.
Assessment Overall assessment of candidates is based on tutor mark assignments, manufacturing facility tour reports and written examinations. Qualified candidates with an overall grade second class (first division) or higher at the end of Year 1 may choose to proceed to the M.Sc. degree. Alternatively students may complete the diploma course schedule.
Candidates who fail to meet the examiners´ requirements may sit supplemental examinations to gain entry to the second year of the diploma programme. (note: students must achieve overall grade second class (first division) or higher at their first attempt to proceed to the M.Sc. degree).
Course work, annual examinations and the M.Sc. dissertation are subject to External Examiner review.
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