The MSc in Pharmaceutical Technology and Quality Systems is a part-time distance learning programme running over a minimum of 24 months from the date of first registration for the programme. This taught MSc is recognised by the Health Products Regulatory Authority (HPRA) as fulfilling the educational requirements for Qualified Person (QP) status required by EC Directive 2001/83/EC and so forms a good starting point for suitably experienced graduates to apply to the HPRA for registration as a QP*.

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 Health Products Regulatory Authority (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.

Programme Requirements (Pathway 1)
In Part I students take taught modules to the value of 60 credits, run over a minimum of 18 months. The taught modules will 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 3-day workshops on campus per year, involving lectures, practical sessions, tutorials and industrial site visits.

In Part II students complete a research project module to the value of 30 credits. The conditions of employment of graduates wishing to pursue the programme should be such that they may carry out their research project in their place of employment.

Students take 90 credits as follows:

Part I
PF6200 Pharmaceutical Chemistry (10 credits)
PF6201 Pharmaceutical Dosage Form Design (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)
PT6401 Pharmacology (5 credits)

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

Module Semester Information may be found here. Module Descriptions may be found here.

Part II
PF6210 Dissertation in Pharmaceutical Technology and Quality Systems (30 credits)
The research project will be centred in an industrial pharmaceutical setting. Consideration will be taken of the candidate's chosen project area but all project titles must be approved in advance by the programme committee and supervised by a member of academic staff at UCC.

Module Semester Information may be found here. Module Descriptions may be found here.

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

PF6210 Dissertation in Pharmaceutical Technology and Quality Systems (30 credits)
The research project will be centred in an industrial pharmaceutical setting. Consideration will be taken of the candidate's chosen project area but all project titles must be approved in advance by the programme committee and supervised by a member of academic staff at UCC.

Examinations
Full details and regulations governing Examinations for each programme will be contained in the Marks and Standards 2019/2020 Book and for each module in the Book of Modules, 2019/2020.

See also General Regulations for the Degree of Master.

Postgraduate Diploma in Pharmaceutical Technology and Quality Systems
A candidate who passes all taught modules in Part I (60 credits) may opt to exit the programme and be conferred with a Postgraduate Diploma in Pharmaceutical Technology and Quality Systems.

Programme Learning Outcomes for MSc in Pharmaceutical Technology and Quality Systems (NFQ Level 9, Major Award)
On successful completion of this programme, students should be able to:

• Identify and evaluate the role of Quality Systems and Good Manufacturing practices (GMP) in the pharmaceutical industry, and to be aware of the latest trends in good clinical, manufacturing, laboratory, validation and distribution practices;
• Define the legal basis and professional duties of the Qualified Person as defined by EC Directive 2001/83/EC and apply a risk based approach to the evaluation of quality, safety and efficacy of pharmaceutical products;
• Derive and apply a science based approach to solving quality based problems in the manufacture of pharmaceuticals;
• Demonstrate a comprehensive knowledge of pharmaceutical sciences, which includes a sound basis in pharmaceutical chemistry and analysis, pharmacology, pharmaceutics, microbiology and biochemistry;
• Apply the principles of pharmaceutical dosage-form design and the technologies involved in industrial manufacture of medicinal products (both sterile and non-sterile) to the production of pharmaceutical products;
• Outline the stages of industrial drug development, from drug discovery, development, testing and clinical trials, registration and post marketing activities;
• Recognise the role and influence of regulatory bodies which controls the development, registration, manufacture and distribution of pharmaceutical products;
• Prepare and review written protocols/reports that provide a clear description of an investigation or study, associated experiments and actions taken, and provide an appropriate conclusion;
• Work effectively as an individual, in teams and in multi-disciplinary settings.

Programme Learning Oucomes for Postgraduate Diploma in Pharmaceutical Technology and Quality Systems (NFQ Level 9, Major Award)
On successful completion of this programme, students should be able to:

• Identify and evaluate the role of Quality Systems and Good Manufacturing practices (GMP) in the pharmaceutical industry, and to be aware of the latest trends in good clinical, manufacturing, laboratory, validation and distribution practices;
• Define the legal basis and professional duties of the Qualified Person as defined by EC Directive 2001/83/EC and apply a risk based approach to the evaluation of quality, safety and efficacy of pharmaceutical products;
• Derive and apply a science based approach to solving quality based problems in the manufacture of pharmaceuticals;
• Demonstrate a comprehensive knowledge of pharmaceutical sciences, which includes a sound basis in pharmaceutical chemistry and analysis, pharmacology, pharmaceutics, microbiology and biochemistry;
• Apply the principles of pharmaceutical dosage-form design and the technologies involved in industrial manufacture of medicinal products (both sterile and non-sterile) to the production of pharmaceutical products;
• Outline the stages of industrial drug development, from drug discovery, development, testing and clinical trials, registration and post marketing activities;
• Recognise the role and influence of regulatory bodies which controls the development, registration, manufacture and distribution of pharmaceutical products;
• Work effectively as an individual, in teams and in multi-disciplinary settings.