Pharmaceutical Regulatory Sciences
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University College Cork

Pharmaceutical Regulatory Sciences

Course Outline
Do you have an interest in developing your career in regulatory or quality roles in the pharmaceutical or healthcare industries? Do you want to enhance your employment prospects with a new and emerging career pathway? The Postgraduate Diploma in Pharmaceutical Regulatory Sciences may be just the right course for you – graduates of this programme are highly sought by the industry with over 80% securing a new role within one year of completion!

This level-9 Postgraduate Diploma offers students a qualification in how to apply a science-driven approach to ensure medicines are developed and manufactured to the highest quality standards, with content to meet the existing needs and emerging trends of the pharmaceutical industry. Graduates will not only be trained on the regulatory affairs applied in the pharmaceutical industry, but will also develop skills on the science and risk based methods applied in drug development and manufacture. This course broadens the professional development of students by challenging them to use critical-thinking to overcome industrial problems and developing transferable skills.

Additional Teaching Mode Information
This course will be delivered in a blended manner comprising online recordings, course notes, learning exercises and face-to-face teaching. This blended learning embraces the 'flipped classroom' approach, facilitating a dynamic and interactive learning environment.

Course Practicalities
2023 Timetable information:

This course will be delivered in a blended manner comprising online recordings, course notes, learning exercises and face-to-face teaching. This blended learning embraces the 'flipped classroom' approach, facilitating a dynamic and interactive learning environment.

During semester 1 & 2, face-to-face workshops will run on Thursday evening and Friday afternoons on the UCC Campus. Lectures and course notes will be delivered online, giving students the flexibility to cover the material at their own convenience during the week, with no requirement to be online at a particular time.

There will be 6 hours of live workshops. An additional 14 hours will be required to cover the online lectures/material (asynchronous) plus approx. 20 study hours per week.

To try and accommodate people in employment, our face-to-face hours on UCC campus are as follows (2022):

Semester 1 & 2
Thursday 6 - 9pm
Friday 3 - 6pm

The rest of the material in semester 1 and 2 will be delivered online.

Subjects taught

The Postgraduate Diploma in Pharmaceutical Regulatory Sciences is suitable for those wishing to pursue a career in the pharmaceutical, and/or healthcare industries. This inter-disciplinary course will be delivered by the Schools of Pharmacy, Mathematical Sciences and Public Health providing students with a unique skill-set covering pharmaceutical operations, data science and public health. Student workload will be up to 20 hours per week with a minimum of 20 additional study hours per week. Modules include:

ST6024 Introduction to Probability & Statistics (5 credits): To provide a strong foundation in the principles of statistics & probability and its application to an industrial setting

ST6025 Statistical Modelling (5 credits): Theory of regression models and generalised linear models and its application in predicting outcomes.

ST6026 Basics of Machine Learning (5 credits): Foundational theory and applications of statistical learning, data science and machine learning

PF6026 Pharmaceutical Technology and Unit Operations (5 credits): Scientific theory and technologies behind the manufacture of drug substances and drug products

PF6027 Pharmaceutical GxP and Regulatory Science (5 credits): An overview of regulatory affairs in the pharmaceutical industry and the scientific tools applied in evaluating quality of medicines

PF6028 Process Control and Validation for Pharmaceutical Processes (5 credits): Introduction to the principles of validation, qualification and process control in the pharmaceutical industry

PF6029 Biotechnology-derived & Advanced Therapy Medicinal Products (ATMPs) (5 credits): An overview of the development, production, translation and regulation of biotechnology-derived pharmaceuticals and ATMPs (e.g., vaccines, gene medicines)

EH6136 Pharmacoepidemiology (5 credits): To develop skills in the study of the utilisation and effects of drugs in large numbers of people, including clinical trials.

EH6137 Pharmaceutical Data Management and Pharmacovigilance (5 credits): Introduction to pharmacovigilance, incorporating drug safety, comparative effectiveness, adverse event detection and reporting.

Entry requirements

Applicants must have a Second Class Honours Grade 1 in a primary honours degree (NFQ, Level 8) or equivalent, in any of the following areas: chemical, biological and medical sciences, pharmacy, mathematical and computer science, engineering, public health, business information systems.

A quota will be allocated to applicants who do not meet these entry requirements. These applicants will be considered under Recognition of Prior Learning and assessed on the following factors:

Academic achievement
Prior Work Experience
Letter of Reference
Personal Statement

All applicants whose first language is not English must provide evidence of English language proficiency. See our English language proficiency requirements.

Application dates

Applications for 2023 will open shortly. Register your interest here.
2022 Application Information:

Candidates are advised to apply early as high demand is anticipated and places are limited.

Applications will only be assessed when all supporting documentation has been received. Please ensure that you have the documentation below available at the time of application.

For mainstream applications, you will need:

Copies of transcripts and parchments for any previous relevant educational qualifications
Personal / Motivation Statement - In 500 words or less, please state:

1) Why you wish to study this programme at University College Cork

2) How you meet the programme entry requirements
Current CV

Copy of an up to-date University approved English language exam e.g. IELTS, TOFEL, Duolingo etc., for non-native English speakers
For applications considered under Recognition of Prior Learning (RPL), you will need:

Copies of transcripts and parchments for any previous relevant educational qualifications

Current CV

References where applicable

Personal / Motivation Statement - In 500 words or less, please state:

1) Why you wish to study this programme at University College Cork

2) How you meet the programme entry requirements
Copy of an up to-date University approved English language exam e.g. IELTS, TOFEL, Duolingo etc., for non-native English speakers

Duration

1 year full-time.

Post Course Info

Skills and Careers Information
What are the employment opportunities in this field?
Regulatory science has been identified as a major skills gap in Ireland, with the Expert Group on Future Skills Needs report (2016) emphasising the "demand for scientists with experience in compliance, regulatory affairs and new product development." Graduates of this programme are highly employable regionally, nationally and internationally, with over 80% securing a new role within one year of completion.

What is the pharmaceutical industry like in Ireland?
The pharmaceutical industry is a major part of the Irish economy. According to IDA Ireland:

Ireland has €80bn in annual exports of pharmaceutical products
85+ pharmaceutical companies operate in Ireland
Ireland is the 3rd largest exporter of pharmaceuticals globally

What sort of jobs would this course prepare me for?
This programme ideally prepares candidates for quality and regulatory roles in the pharmaceutical industry. However, the skills acquired as part of this programme are also highly applicable to other roles within the pharmaceutical industry.

On successful completion of the programme, students should be capable of working in a regulated pharmaceutical sector, including drug development, regulatory compliance, process control and process validation.

Will I get exposure to the pharmaceutical industry in this course?
Given that Cork is a global pharmaceutical hub, this course will have direct input from these companies, via guest lectures, industrial-based projects and site tours.

Are there any career workshops included as part of this course?
Career workshops will be delivered as part of this course and students will have access to the UCC career services. Main activities will include:

Formulating individual career action plans leading to employment, reflecting on:
Where are they now in their careers?

Where do they want to be?
Strategies for gaining employment on completion of the programme.
Job readiness workshops including:
Positioning oneself for job readiness: Setting realistic career objectives; Understanding strengths and skills; Learning from successful role models; Developing a career management strategy
Creative job-hunting both on-line and off-line: Written applications, CVs and interview preparation.Participants will be given the opportunity to meet employers by attending UCC organised recruitment fairs, jobs roadshows and other events where employers will be invited on campus to meet students.

Participants will be given the opportunity to meet employers by attending UCC organised recruitment fairs, jobs roadshows and other events where employers will be invited on campus to meet students.

More details
  • Qualification letters

    PgDip

  • Qualifications

    Postgraduate Diploma (Level 9 NFQ)

  • Attendance type

    Full time,Daytime

  • Apply to

    Course provider