Pharmaceutical Regulatory Sciences

Course Outline
Do you have an interest in developing your career in regulatory or quality role in the pharmaceutical, medical device 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!

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. Programme content has been designed 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. The course is designed in a blended learning format combining online learning elements with face-to-face workshops, providing students with a modern 'flipped classroom' approach to learning. Finally, this course is designed to broaden the professional development of all candidates, including challenging students to use critical-thinking to overcome industrial problems and to develop transferable skills to advance their careers.

Advance your career, apply today and start your UCC journey in September!

Why Choose This Course
What is regulatory science?
Regulatory science is the science of developing new tools, standards, and approaches to assess the quality, safety and efficacy of medicines. With the significant evolution in technologies used in manufacture of medicines and the increasingly diverse types of medicinal products being developed, it is vital that our methods of assessing quality of medicines evolve to be flexible, yet robust at assuring safe and effective drug products for patient use.

How does this regulatory science programme differ from regulatory affairs courses?
This postgraduate diploma in regulatory science is a science-driven approach to drug product development and regulation. Regulatory affairs courses focus on the study of current drug regulation and regulatory requirements. While this programme covers regulatory affairs in a global manner, a scientific emphasis is provided on all topics, challenging students to use critical-thinking to overcome problems and provide science-based solutions.

Who should apply?
This programme is ideal for high achieving graduates from a range of backgrounds (science, health-related, numerate, quantitative business) who have an interest in upskilling and diversifying into the pharmaceutical industry. In addition, this programme would also be suitable to candidates who have strong experience in the pharmaceutical industry and wish to upskill.

The Postgraduate Diploma in Pharmaceutical Regulatory Sciences is suitable for those wishing to pursue a career in a regulatory and/or quality assurance role in the pharmaceutical, medical device and/or healthcare industries. The course is designed in a blended learning format, with learning material available both online and in a face-to-face format. Student workload will be up to 20 hours per week with a minimum of 20 additional study hours per week. Students will complete 60 credits as follows:

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

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

PF6030 Industrial based project and skills development for an industry-based setting (15 credits): Practical experience in addressing a research question and conducting a research project on a topic of relevance to the pharmaceutical industry. In addition, this module will provide careers training.

This inter-disciplinary course will be delivered by the Schools of Pharmacy, Mathematical Sciences and Public Health at UCC. Students will complete an industry-based project that will facilitate a Work-Integrated Learning (WIL) approach, where students will apply their theoretical learning within the practice of an industrial research project. On successful completion of 60 credits of modules, students should be capable of working in a regulated pharmaceutical sector, including drug development, regulatory compliance, process control and process validation.

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

Apply and assess relevant mathematical techniques to the pharmaceutical industry e.g., statistical modelling, machine learning approaches, statistical process control of pharmaceuticals.

Interpret the regulatory requirements for licensing and manufacture of medicinal products in the EU

Evaluate the key parameters/attributes for pharmaceutical manufacturing processes for medicines, including conventional drug products, biotech-derived medicines and advanced therapy medicinal products (e.g., gene medicines)

Explain approaches to validation throughout the pharmaceutical life cycle and prepare validation documentation

Apply principles of pharmacoepidemiology (study of the utilisation and effects of drugs in large numbers of people)

Demonstrate an understanding of pharmacovigilance (activities related to the detection, assessment, understanding and prevention of adverse effects).

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.

How Do I Apply
Currently closed for applications.

Fill out our Expression of Interest Form for 2022

Interest in Human Capital Initiative Course Form (see website).

2022 Application Information:

Applications will be accpted online at Springboard Application System

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. Documents must be combined into one zip file and uploaded. Uploading of multiple documents is currently not facilitated.

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

Apply online via the Springboard Platform

1 year full-time.

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.

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." Therefore, graduates of this programme will be highly employable regionally, nationally and internationally.

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

- 9 of the top 10 world's pharmaceutical companies are located in 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 would ideally prepare candidates for quality and regulatory roles in the pharmaceutical industry. However, the skills acquired as part of this programme would also be highly applicable to other roles within the pharmaceutical industry.

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 the 'Industrial based project and skills development for an industry-based setting' module. In addition, students will have access to the UCC career services. Main activities will include:

1. Career coaching to formulate 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.

2. Job readiness workshops will be built into the programme as outlined below:
- Positioning oneself for job readiness: Setting realistic career objectives; Understanding strengths and skills; Learning from successful role models; Developing a career management strategy.

- Moving forward into a job: Taking action by developing career goals and implementing them;

- Creative job-hunting both on-line and off-line; Written applications, CVs and interview preparation and implementing career plans.

3. 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.