Course Code: CKX05 Part-time
Course Title: Pharmaceutical Technology and Quality Systems Online Course
College: Medicine and Health
Duration: 2 years Part-time
Course Delivery Method*: Online
Teaching Mode: Part-Time, Distance Learning
This programme will be taught online.
NFQ Level: Level 9
Costs: 2017/2018 Irish/EU €8,730 per year; 2017/2018 Non-EU fee: €15,000 per year
2017 Entry Requirements: Minimum 2.2 honours degree (NQAI level 8) in a science discipline approved by the course committee (e.g, pharmacy, chemistry or biological sciences). See Detailed Entry Requirements
Closing Date: Now closed for applications for 2017/2018
Next Intake: September 2018
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.
Modules (90 credits):
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)
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)
Students may take individual modules as continued professional development.
Further details on the content and modules are available on the Postgraduate College Calendar
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 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 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
Note: English Language Requirements
All applicants whose first language is not English are required to sit either an IELTS or TOEFL test.
The minimum English Language Requirements for Postgraduate Degree Programmes are:
College of Medicine and Health: minimum IELTS 6.5; with no individual section lower than 6.5. Further information on English Language Requirements can be found at here
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.
Application for this programme is on-line at www.pac.ie/ucc. Places on this programme are offered in rounds. The closing dates for each round can be found here. For full details of the application procedure click How to apply.
Please note that you will be asked to upload a supplementary document as part of the application process for this programme. The supplementary information required is available to view here SupplementaryQuestionsCKX05 (13kB)
All required documentation must be either uploaded to your online application, or sent in hard copy to The Postgraduate Applications Centre, 1, Courthouse Square, Galway, immediately after an application is made.
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.
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.
Course Coordinator MSc in Pharmaceutical Technology and Quality systems
School of Pharmacy
Cavanagh Pharmacy Building
University College Cork
Fax: + 353-(0)21-4901656
Dr Brendan Griffin
T: +353 (0)21 490 1657