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.

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.

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.

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)

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

Modules
Further details on the modules listed above can be found in our book of modules. Any modules listed above are indicative of the current set of modules for this course but are subject to change from year to year.

University Calendar
You can find the full academic content for the current year of any given course in our University Calendar.

Requirements
Please note you will be required to provide additional information as part of the online application process for this programme. This will include the following questions:

Please download complete & upload this Company Reference Template.

Entry Requirements (Pathway 1)
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 in a primary honours degree (NFQ, Level 8) in a relevant science discipline 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 under Recognition of Prior Learning (RPL) 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.

English Language Requirements
Applicants that are non-native speakers of the English language must meet the university approved English language requirements.

For applicants with qualifications completed outside of Ireland:
Applicants must meet the required entry academic grade, equivalent to Irish requirements.

International/non-EU applicants
For full details of the non-EU application procedure please visit our how to apply pages for international students. 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.

Not all courses are open to international/non-EU applicants, please check the fact file above.

For more information please contact the International Office.

Closing Date: 10 June 2022.

How Do I Apply

1. Choose Course
Firstly choose your course. Applicants can apply for up to two courses under one application. Details of taught courses are available on our online prospectus.

2. Apply Online
Once you have chosen your course you can apply online at the online application portal. Applicants will need to apply before the course closing date. There is a non-refundable €50 application fee for all courses apart from the Education - Professional Master of Education - (Secondary School/Post-Primary Teacher Training) which has a €100 application fee.

Applicants for the Postgraduate Diploma in Public Health Nursing must apply on the PAC website when the programme opens for applications.

3. Gather Supporting Documents
Scanned copies of the following documents will need to be uploaded to the online application portal in support of your application. Applicants may need to produce the original documents if you are accepted onto a course and register at UCC.

- Original qualification documents listed on your application including transcripts of results from institutions other than UCC

- Any supplementary items requested for your course.

Please log into the online application portal for more details.

4. Application processing timeline
Our online application portal opens for applications for most courses in early November of each year. Check specific course details.

5. Rounds
For courses that are in the rounds system (Irish and EU applicants), please check the rounds closing dates.

Questions on how to apply?
Please use our web enquiry form to contact us.

Additional Requirements
Please be advised that all Irish/EU applications will be reviewed after the closing date of the 11th June 2021 has passed regardless of the initial date of application.

The closing date for non-EU applications is 30 April 2022.

Assessment

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 Canvas. The value of the continuous assessments varies for each module but can count for 20-50% of the overall mark.

2 years part-time. Distance learning.

Additional Teaching Mode Information
This programe is taught as a blended learning programme, with both online content and block attendance at UCC.

Start Date:7 September 2020

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.