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Pharmaceutical Technology & Quality Systems

Course Outline
This two-year distance learning course is aimed at graduates who currently work within the pharmaceutical industry who wish to fulfil the EU educational requirements for Qualified Person (QP) status. Graduates who complete this course and have the relevant work experience are eligible to apply to the Health Products Regulatory Authority (HPRA) or EU regulatory authority to register as a QP.

The course is not limited to aspiring QPs. It is designed to broaden your professional development and provide up-to-date assessments of the latest trends in the areas of pharmaceutical/ biopharmaceutical development, manufacturing and quality. The individual modules provide knowledge and experience of benefit to all technical, quality, regulatory and managerial staff in the pharmaceutical industry. Individual modules may be taken as CPDs.

Course Requirements (Pathway 1)
In Part I, you will take taught modules to the value of 60 credits, run over a minimum of 18 months. The taught modules incorporate a combination of self-instructional printed materials (i.e. printed module workbooks), teleconferences, web-based seminars and online assessments. Students must also attend the two three-day workshops on campus each year, involving lectures, practical sessions, tutorials and industrial site visits.

In Part II, you complete a research project module to the value of 30 credits. If you want to pursue the course, you must be able to carry out your research project in your place of employment.

Why Choose This Course
The MSc in Pharmaceutical Technology and Quality systems has been approved by the HPRA in meeting the educational requirements for QP status as stated in directive 2001/83/EC. Students who have completed this course and have the relevant work experience are eligible to apply to an EU regulatory authority to register as a QP.

Entry requirements

All candidates must be approved by the programme committee within the School of Pharmacy. Applicants may be short listed for interview.
-a candidate must have obtained at least a Second Class Honours primary degree in a relevant science discipline (NFQ level 8) which has been approved by the programme committee (e.g. pharmacy, chemistry or the biological sciences);
-candidates must be currently employed in a relevant pharmaceutical sector (ideally greater than two years experience) and for the duration of the programme;
-consideration may be given to other applicants with suitable equivalent professional qualifications and significant industrial experience (greater than 5 years relevant experience in the pharmaceutical industry).

*Note: Candidates who successfully complete this programme and wish to become a QP must apply to the HPRA to become registered as a QP and should also note the following:
-they must also have an appropriate primary degree that is considered by the HPRA to meet the specific requirements for primary qualifications listed in article 49 of 2001/83/EC (e.g. chemistry, pharmaceutical chemistry and technology, biology);
-they must provide evidence to the Health Products Regulatory Authority (HPRA) that they 'have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of testing and checking necessary to ensure the quality of medicinal products'.

Entry Requirements (Pathway 2)
In addition to the above:

The Programme Management Committee may permit graduates holding a Postgraduate Diploma (equivalent to NFQ Level 9 award) in Pharmaceutical Technology and Quality Systems from an appropriately accredited School of Pharmacy to enter a one year programme. To be considered for entry to this programme, candidates must have completed their Postgraduate Diploma no later than five years prior to the date of registration for this programme. All candidates must be approved by the programme committee within the School of Pharmacy. Applicants may be short listed for interview.

If you are applying with Qualifications obtained outside Ireland and you wish to verify if you meet the minimum academic and English language requirements for this programme please click here to view the grades comparison table by country and for details of recognised English language tests.

Non-EU Candidates

Non-EU candidates are expected to have educational qualifications of a standard equivalent to Irish university primary degree level. In addition, where such candidates are non-native speakers of the English language they must satisfy the university of their competency in the English language.

For more detailed entry requirement information please refer to the International website .

Duration

2 years part-time. Distance learning.

Consisting of taught modules by distance learning running from September to April each year. In second year, the research project runs from April to October/November.

The taught modules incorporate printed module workbooks, teleconferences, web-based seminars and online assessments. Each module runs for approximately four weeks. The average amount of directed study that you are advised to undertake per module is about 10-15 hours per week.

Teleconferences and webinars are held regularly throughout the year.

Students must attend a three day workshop held in UCC at the end of each semester, usually in December and February.

Exams are held in UCC in April. In some cases, arrangements can be made to sit the exams at a different university.

Careers or further progression

Skills and Careers Information

Although the course meets the educational requirements for registering as a QP, it is not only aspiring QPs who complete the course. Many of our graduates use the skills obtained in the course to develop their careers within other areas of the pharmaceutical industry.

Students from the EU can use this qualification to apply to your regulatory authority to register as a QP. Last year, a number of students from Malta graduated from this course and registered as QPs in Malta.

Individual modules can be studied as part of Continuing Professional Development (CPD).

Further enquiries

Linda McGuire
l.mcguire@ucc.ie
+ 353 21 490 1736
http://www.ucc.ie/en/pharmacy/

Dr. Brendan Griffin
brendan.griffin@ucc.ie
+ 353 21 490 1657

Subjects taught

Modules (90 credits):

Part I
PF6200 Pharmaceutical Chemistry (10 credits)
PF6201 Pharmaceutical Dosage Form Design (5 credits)
PT6401 Pharmacology (5 credits)
PF6202 Pharmaceutical Manufacturing - API to Finished Product (5 credits)
PF6203 Pharmaceutical Microbiology and Sterile Manufacturing (5 credits)
PF6204 Biopharmaceutical Development of Investigational Medicinal Products (5 credits)
PF6205 Pharmaceutical Biotechnology (5 credits)
PF6206 Pharmaceutical Statistics and Process Control (5 credits)
PF6207 Pharmaceutical Plant and Process: From Design through Validation (5 credits)
PF6208 Quality Management Systems and Regulatory Affairs (5 credits)
PF6209 Role and Professional Duties of the Qualified Person (5 credits)

Part II
PF6210 Research Project — Pharmaceutical Technology and Quality Systems (30 credits)
The research project will be centred in an industrial pharmaceutical setting. Consideration will be given to your chosen project area but all project titles must be approved in advance by the course committee and supervised by a member of academic staff at UCC.

Note: Taught modules will be offered on a cyclical basis over alternative years.

Course Requirements (Pathway 2)
Students take 30 credits as follows:

PF6210 Research Project — Pharmaceutical Technology and Quality Systems (30 credits)

CPD
Students may take individual modules as continued professional development.

Further details on the content and modules are available on the Postgraduate College Calendar

Additional Teaching Mode Information
This programme will be taught online

**All Applicants please note: modules listed in the course outline above are indicative of the current set of modules for this course, but these are subject to change from year to year. Please check the college calendar for the full academic content of any given course for the current year.

In UCC, we use the term programme and course interchangeably to describe what a person has registered to study in UCC and its constituent colleges, schools and departments.

Assessment method

Assessment consists of a mixture of continuous assessment and end-of-year written exams. Exams take place in April each year, with repeats in autumn if required.

Continuous assessments form part of each taught module and can be in various formats such as online MCQs, essays and interactive exercises on blackboard. The value of the continuous assessments varies for each module but can count for 20-50% of the overall mark.

Application date

Closing Date of application 14 June 2019

Non-EU Closing Date 15 June

Enrolment and start dates

Start Date 9 September 2019

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