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Institution / Institute of Technology Carlow Carlow Campus
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Pharmaceutical Regulatory Affairs

What is this programme about?

This MSc. will develop knowledge of the design, development, analysis and production of medicines, the drug industry and regulatory affairs. It is particularly suitable for those who are keen to enter employment in areas such as pharmaceutical marketing, formulation, sales, production, public relations, regulatory affairs, process development, medical statistics and clinical trial organisations.

Students will learn about a broad range of formulations and pharmaceutical technologies through the use of examples and case studies along with the underpinning science. They will be given hands-on experience in a number of pre formulation and formulation technologies. Clinical trials and other aspects of regulatory affairs, including those covering biotechnological products will be covered in an integrated manner. Employability has been embedded into the course and the varied assessment strategies reflect this.

Learning Outcomes
On completion of this programme, students should be able to:

• Devise and implement global
strategies for drug, biologic, and
device development and evaluation;

• Apply principles of basic and applied pharmaceutical sciences in drug and biologics discovery and development;

• Apply principles of basic and applied pharmaceutical sciences in drug and biologics discovery and development.

Entry requirements

What are the minimum entry requirements?
Applicants must normally have a first or second class Level 8 honours degree (NFQ or other internationally recognised equivalent) in a science, business, engineering or management subject(s). In certain cases a blend of qualifications, motivation and relevant experience will be acceptable. Applicants applying for entry through progression routes other than those listed above will be considered on a case by case basis using equivalent prior learning that is recognised by IT Carlow as meeting this requirement in line with the Institute RPL policy.

All applicants will be considered on a case by case basis. Lifelong Learning reserves the right to require applicants to attend for an interview to determine their suitability for the programme.

Duration

Springboard participants take the MSc 1 year part-time.
Option for self financing students to take MSc over two years part-time.

CLASSES
Springboard - 2 days and 2 evenings per week.
Self-financing students over 24 months, two evenings per week from 7-10pm.

Further enquiries

Lifelong Learning Centre
Institute of Technology Carlow,
Kilkenny Road,
Carlow.
Tel: 059 9175280
Fax: 059 9175005
Email: lll@itcarlow.ie
Web: www.itcarlow.ie/lll

Subjects taught

Indicative Course Syllabi
Regulatory Affairs Quality Management and Strategy
Research Methods and Technical Report Writing
Pharmaceutical Technology Regulatory Affairs
Pharmaceutical Technologies: Design, Development and Testing
Clinical Evaluation of Pharmaceutical Technologies
Dissertation
Product Programme Management, Vigilance, Surveillance and Risk Management

Comment

Awarded By IT Carlow

Exam Information
Modules completed in Term 1 will, where applicable, be examined in week beginning 12th December 2016. Modules completed in Term 2 will, where applicable, be examined in May 2017.

Course fee

FEES FOR 2016-17 €3,700 per year Springboard applicants. See www.springboardcourses.ie

Enrolment and start dates

Starting Date September 2016

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