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Masters in Pharmaceutical Technology and Quality Systems

College of Medicine and Health
PAC Course Code: CKX05
Qualification: MSc
Duration: 2 years part-time.
EU Fees: The part-time EU fee for this programme for the academic year 2012/13 is 8730.00 euros A similar fee will be payable in the second year of the programme in 2013/2014.
Closing Date - EU Applicants: Fri, 01 June 12
Closing Date - Non-EU Applicants: Fri, 01 June 12

Overview of Pharmaceutical Technology and Quality Systems (MSc)

This two-year distance learning MSc programme, developed by the School of Pharmacy UCC, is targeted at suitably-qualified graduates who are currently working within the pharmaceutical industry.

The course is recognised by the Irish Medicine Board (IMB) as fulfilling the educational requirements for Qualified Person (QP) status as defined in EC 2001/83/EC, and so graduates of this QP traning course, who have relevant work experience, are eligible to apply to the IMB to register as a QP*.

However, the MSc, Programme is not solely for aspiring QP's. The individual modules will provide knowledge and experience of benefit to all technical, regulatory, quality and managerial staff within the pharmaceutical industry. The course is designed to broaden the professional development of all its participants and provide an up-to-date assessment of the latest trends in Pharma/Biopharm development, manufacturing and quality perspectives, including a number of seminars/teleconferences from invited industrial experts.

A summary of the key course objectives are listed as follows:

To provide participants with an in-depth knowledge of the pharmaceutical sciences as it relates to the development, processing and control of medicinal products.
To develop a comprehensive understanding of pharmaceutical processing and manufacturing technologies
To provide a comprehensive overview of the regulatory framework which controls the development, manufacture and distribution of medicinal products and to provide an up to date assessment of the latest trends in pharmaceutical quality systems and GMP.
To present a comprehensive appreciation of all stages of the pharmaceutical drug development cycle, ranging from drug discovery, development and clinical trials to registration and post marketing activities.
To explain the role of the QP and apply a science based approach to evaluation of the quality safety and efficacy of medicinal products.
To broaden the professional development skills of all candidates with an emphasis on developing project management, problem-solving and risk assessment techniques.

In summary this course is designed to ensure graduates are ideally equipped to make crucial decisions regarding the Quality, Safety and Efficacy of medicinal products

* Note: Potential Candidates should note the IMB requirements for registration as a QP as defined in Article 49 of EU Directive 2001/83/EC.

What will I be Studying?

The course is organised around a two year cycle, during which the eleven taught modules are studied in the first eighteen months (Part 1) and a resarch project is conducted for the remaining six months (Part II)

Part 1

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)

In Part 1 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, web-based e-learning packages and on-line assessments. Regular on-line tutorial seminars will be arranged via teleconferencing, therein facilitating an interactive e-learning environment between the students, the module co-ordinators and invited industry speakers. Students must also attend the two 3-day workshops on campus per year, involving lectures, practical sessions, tutorials and industrial site visits. The workshops are designed to complement the theoretical content of the course and provide the candidates with practical hands-on tuition. A major feature of the workshops will be a focus on industry based case studies, with expert advice from invited industrial speakers and an emphasis on applying a science based approach to solving quality based problems in the manufacture of pharmaceuticals.

Note: Taught modules will be offered on a cyclical basis over alternative years (Cycle 1: PF6202/6203/6206/6207/6208/6209; Cycle 2: PF6200, PT6401, PF6201/6204/6205)

Part II

PF6210 Research Project (30 Credits)

In Part II students complete a research project module to the value of 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.

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

A full description of the above modules is available from the Book of Modules 2009/2010

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 (NQAI 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 (> 5 years relevant experience in the pharmaceutical industry).

English Language Requirements:

IELTS 6.5 or TOEFL equivalent

Part-Time Taught Postgraduate Programmes

Please note that non-EU applicants are not eligible to study part-time programmes

Application Procedure

Application for this programme is on-line at www.pac.ie/ucc. For full details of the application procedure click here.

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.

Find out More

Informal enquiries may be made to Course Coordinator or Programme director

Ms. Linda McGuire, Course Coordinator MSC in Pharmaceutical Technology and Quality Systems, School of Pharmacy, Cavanagh Pharmacy Building UCC, Cork, Ireland.

Tel: +353 (0)21 4901736. Email: L.Mcguire@ucc.ie

Dr. Brendan Griffin, Programme Director MSC in Pharmaceutical Technology and Quality Systems, School of Pharmacy, University College Cork.

Email: brendan.griffin@ucc.ie

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