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2. Postgraduate
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4. HCI Courses
5. Postgraduate Diploma Pharmaceutical Regulatory Sciences

Course Fact File

Code	PDPRS
Duration	1 Year
Teaching Mode	Full-time. See Additional Teaching Mode Information for more info.
Qualifications	PG Dip
NFQ Level	Level 9
EU Fees	Free or 90% funded See Fees and Costs for full details.
Closing Date	Rolling deadline. Open until all places have been filled. Early application is advised.
Credits	60
Start Date	9 September 2024

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.

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

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.
• PF6032 Bioprocessing Unit Operations (5 credits): introduction to the manufacture of biopharmaceutical (biologic) products and the unit processes involved.
• PF6038 Skills Development in Pharmaceutical Regulatory Sciences (10 credits): Integrating knowledge relating to new tools, standards, and approaches to assess the quality, safety and efficacy of medicines.

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

• Assess pharmaceutically relevant datasets using appropriate statistical and machine learning methodologies
• Develop manufacturing processes which apply quality-by-design principles for a range of medicinal products including small molecules, biopharmaceuticals and ATMPs
• Critically evaluate the regulation of medicinal products and identify opportunities to accelerate the integration of emerging science and technology in medicines’ development
• Appraise the quality, safety and efficacy of a medicine based on the clinical trial outcomes and real-world data.

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 for Semester 1 & 2:
  
  • Thursday 6 - 9pm
  • Friday 3 - 6pm

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

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.

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 3^rd 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:

1. Formulating individual career action plans leading to employment, reflecting on: 
   1. Where are they now in their careers?
   2. Where do they want to be?
   3. Strategies for gaining employment on completion of the programme.
2. 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.
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.

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.

Under Recognition of Prior Learning (RPL) applicants who do not meet the above academic entry requirements may be considered for admission and will be assessed on a number of factors including: 

• Academic Achievement 
• Prior Work Experience 
• Personal Statement 

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

Fees and Costs

Places will be subsidised under the Human Capital Initiative (HCI) Pillar 1 as follows:

• Standard EU Fee: €9,300
• 90% Subsidised Fee: €930 payable by applicant
• 100% Subsidised Fee: No course fees payable by applicant

For full details on subsidies available please see 'What will it cost?' on the main HCI Pillar 1 webpage

How To Apply

 Applications must be made on Springboard+.  

• If you already have a Springboard+ account, please apply here 
• If you are new to Springboard+, please create an account here to apply
• When you log into your existing account or register for a new account, go to the search courses tab and search for the course you are interested in applying for. Further instructions can be found in the 'How to Apply' section of the Springboard+ webpage. 

Applicants are advised to apply early as high demand is anticipated and places are limited. Applications cannot be assessed until all supporting documentation has been received.   

Documentation that you will need for your application:

1. Applicants who meet the Academic Entry Requirements will need:

• Copies of transcripts from all previous relevant educational qualifications. A parchment may also be required in some instances
• A Personal/Motivation Statement: In 500 words or less, please state why you wish to study this programme
• An up-to-date CV

Where English is not your first language you are required to submit a copy of a UCC approved English Language Test/Exam.

2. Applicants who apply under Recognition of Prior Learning (RPL), will need:

• Copies of transcripts from all previous relevant educational qualifications. A parchment may also be required in some instances
• Personal / Motivation Statement - In 500 words or less, please state:

- Why you wish to study this programme
- How your experience, professional and educational, equips you for admission to the course  despite not meeting the academic entry requirements

• An up-to-date CV
• References where applicable

Where English is not your first language you are required to submit a copy of a UCC approved English Language Test/Exam.

3. Eligibility for HCI Pillar 1 Funding: 

In addition to the above, academic, English language and RPL requirements, all applicants must provide proof of the following in order to qualify for HCI Pillar 1 funding:

• Evidence of living full time in the Republic of Ireland
• Evidence of holding a valid Personal Public Service Number (PPSN)
• Evidence of having lived in the EU/EEA/UK/Switzerland for 3 out of the past 5 years
• Evidence of meeting the nationality/visa requirement
• Evidence of meeting one of the following employment statuses:

- Employed

- Unemployed and in receipt of an eligible Department of Social Protection (DSP) payment for 9 out of the past 12 months

- Recent graduate (2023 or 2024)

- Returner

- Self-employed

- Formerly self-employed

The above funding eligibility documentation will be required after acceptance of a provisional offer, and not earlier than 6 weeks prior to course commencement. For more detailed information on what constitutes acceptable evidence please visit the Springboard+ website.