Overview
This course was planned in response to a request from local industry, and will provide
students with an overview of the pharmaceutical industry with emphasis on the R&D
process, regulatory affairs, pharmaceutical process technology, good scientific practice
and the role of the Qualified Person (QP). The latter are key personnel within the industry
since the holder of a manufacturing licence for medicinal products must nominate one or
more QP’s who are responsible for the implementation of a quality system which will
enable them to certify, prior to release within the European Community, the quality,
safety and efficacy of each batch of manufactured medicinal product. Thus, the course is
mainly designed for all people aiming for, or holding, a key position at pharmaceutical
manufacturing firms and service providers within the health sector, whether related to
quality, regulatory affairs, production or product development. The ultimate objective is
to ensure that there is a broad and mutual understanding throughout the organization with
regards to Good Practice in day-to-day operations, and to improve the understanding of
the responsibilities that a Qualified Person (QP) should focus on in ensuring the quality,
safety and efficacy of medicinal products. The course will thus enable students either to
continue their professional development or to prepare themselves more effectively in
approaching the Qualified Person eligibility interview held by the competent authorities
prior to accepting an individual’s nomination as QP.
Eligibility
Candidates with a degree in science with Chemistry as a main area of study obtained with
second class honours or better, a degree in pharmacy obtained with second class honours
or better, or a degree in a related area (as determined by the Board of the Faculty of
Science) obtained with second class honours or better are eligible to apply. The
maximum number of applicants that may be allowed to register for the Course shall be
announced at the time of the call for applications. If necessary, applicants will be selected
after an interview by the Board of Studies.
Course Content
The course will be taught on a part-time basis over a period of two years, taking into
account availability of both students and lecturers. The course consists of a total of 10
study units to which 60 ECTS credits have been assigned. Course delivery will involve
lectures, seminars, practical units and site visits. Students will also be expected to
complete a project as part of the course requirements. An overview of teh study units can be downloaded from here.
Fees
The total cost of the course is of LM3500 tuition fees and LM500 in bench fees, payable
up front or in two installments. The cost for a single study-unit registration is LM400.