Degree in Manufacture of Medicinal Products (DT 291) – Frequently Asked Questions

The BSc in the Manufacture of Medicinal Products is a 6-module online programme that builds upon previously completed certificates to give you a pharma specific BSc degree, which is necessary for career progression to more senior roles in the pharmaceutical manufacturing industry.

Who is this programme for?

The BSc degree is only available to GetReskilled students who have successfully completed the Certificate in eBioPharmaChem and Certificate in eValidation. This is a highly specialised programme taught by industry thought leaders that is only available to experienced workers. This opportunity is only open to a select few – and not something you can just apply for without the necessary work experience and required prior learning.

What is the programme content?

There are 6 modules that make up the programme, which you complete over a two year time period:

Module 1 – Design and Operation of Cleanrooms (VOMP 3013)
This module gives the student an understanding of the fundamentals of cleanrooms and the control of air flow and pressurization between areas, as well as the personnel and material movements within them so as to protect the integrity of the product and minimize the risk of contamination.

Module 2 – Maths and Statistics (VOMP 3004)
This module provides the foundation in Mathematics and Statistics that is required for pharmaceutical manufacturing.

Module 3 – Regulation of Combination Products (VOMP 3020)
This module gives students a broad understanding of the regulations underpinning the manufacture of safe combination products and medical devices. The module will explore:

The regulatory environment for combination products and medical devices
The key elements of a robust Quality Management System (QMS) necessary for the reliable delivery of high quality products
The fundamentals of validation for combination products
An introduction to selected manufacturing technologies involved in the manufacture of combination and device products

Module 4 – Technology Transfer (VOMP3010)
This module gives students a broad understanding of clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs and biologics. In addition, students will get an overview of how to transfer the new drug or biologic technologies to new and existing facilities. As part of this module, you will be expected to read Ben Goldacre’s book “Bad Pharma” and provide a thoughtful analysis.

Module 5 – Physical Chemistry (VOMP3009)
This module provides students with the fundamentals of physical chemistry and enables them to apply these principles to industrial processing. The material covered will allow students to understand the principles of the topics and appreciate the application of these fundamentals to practical problems. In addition, the student is introduced to the safety regulations applicable to the workplace and, in particular, to anywhere chemicals are used. There is a one-day lab practical as part of this module which is held on campus in TU Dublin.

Module 6 – Aspects of Regulatory Science (VOMP3019)
This module gives students a broad understanding of the newly emerging tools, standards, and approaches used by pharmaceutical companies and regulators to ensure the safety, efficacy, quality, and performance of medicinal products, with emphasis on the manufacturing phase of the lifecycle.

This programme works the same way as your eBioPharmaChem and eValidation programmes. Each module is roughly 10 weeks long and the programme has a variety of written assignments and online exams to complete.

At the start of each module, there will be a module orientation day which is held either online or on campus in TU Dublin. This allows you the opportunity to meet your lecturer, get an overview of the assignments you will be asked to complete, and ask any questions you may have about the content.

How is the programme delivered?

All programme learning is done online with the exception of the one day lab practical in Module 5.

All 6 modules are delivered on the TU Dublin online learning platform – Brightspace.

Module 1 is delivered by Dr Joe Brady. Dr Brady is a full-time practicing Validation Lead and an Assistant Lecturer in the School of Chemical and Pharmaceutical Sciences within Technological University Dublin (TU Dublin). He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France, and the USA.

Module 2 is delivered by Dr Ben Schazmann. Dr Schazmann lectures and runs practical classes in Physical, Analytical, Organic, and General Chemistry. Ben enjoys a broad range of chemical disciplines delivered to all undergraduate years and postgraduate classes.

Module 3 is delivered by Dr Nuala Calnan. Dr Calnan has over 20 years experience in the pharmaceutical industry including roles in Leo Pharma, Elan, Wyeth BioPharma (Pfizer), and PM Group. Dr Calnan’s focus is on the integration of Knowledge Excellence, Operational Excellence, and Cultural Excellence in delivering enhanced quality outcomes for the patient, and she has led an Irish Industry research study in this field. She has completed a knowledge management research project into the Product Recall and Quality Defect data at the Irish medicines regulator, HPRA. She also co-leads the ISPE Quality Culture Team as a member of the ISPE Quality Metrics Initiative.

Module 4 is delivered by Dr Brady and Professor Anne Greene. Professor Anne Greene has extensive experience as a pharmaceutical technology and projects manager in Ireland. She is currently a Professor in the School of Chemistry and Pharmaceutical Sciences of Technological University Dublin, leading programmes in Pharmaceutical Technology, Validation, and Pharmaceutical Quality Assurance to undergraduate and postgraduate students. She is also secretary of the Parenteral Drug Association (PDA) Secretary, Irish Chapter.

Module 5 is delivered by Dr Gavin Sewell. Dr Sewell completed his PhD under the supervision of Prof Tia Keyes in 2014. The title of his thesis was “Zeolite Scaffolded Donor-Acceptor Systems for Nanoelectronics”. In addition to his academic experience, Gavin has worked in pharmaceutical, forensic, and environmental testing roles. His research interests include host-guest interactions within microporous and nanoporous materials, zeolite-based sensing devices, and development of novel solid state luminescent materials.

Module 6 is delivered by Professor Anne Greene and Dr Nuala Calnan.

What is the process for getting my degree from TU Dublin?

Upon completion of the programme, your work from all modules (including your eBioPharmaChem and eValidation Certificates) will be submitted to an external exam board at the Technological University Dublin. This external exam board has members from academia as well as key pharma industry leaders. Once the exam board has reviewed and approved your work, you are deemed to have successfully completed your programme of study and will graduate with your BSc in the Manufacture of Medicinal Products.

Degree in Manufacture of Medicinal Products (DT 291)

What is the weekly time commitment for this programme?

The amount of time spent studying varies between students, depending on how they choose to engage with the materials and their previous experience or familiarity with the topics. Most students report taking 10-16 hours per week.

Do I have to login at any specific times?

No, the online classroom is open 24 hours a day so you do not have to login at any particular time. The day the programme starts you are given a username and password that gives you access to your course materials. Some of the lecturers like to make live webinars a regular part of their teaching to allow for more in-depth discussions about the course content. These are all recorded though so if you can’t attend, you can re-watch the recording.

I live in the UK/Europe/USA/Australia, can I still take this programme?

Yes, you can take it from anywhere you have an internet connection. However, you will need to come to Ireland for the one-day lab practical in Module 5.

How much does the programme cost?

The total cost of the two years is €5,688.

Can I spread the cost across multiple payments?

The course costs €5,688 in advance OR €2,844 annually OR €948 per term. There are no additional registration or exam fees – and we do offer monthly payment plans if you’d like to spread the cost out even more.

What follow on programmes do you offer after the degree?

Once you complete the degree, you can consider continuing on to the Masters in Pharmaceutical Validation Technologies, which is also run online by TU Dublin. In fact, a lot of the lecturers on the BSc programme also lecture on the Masters programme – so you would see a lot of familiar faces if you chose to continue your studies.

I’ve never studied at degree level, am I suitable?

If you’ve been given this opportunity then based on your previous performance on our courses, we believe you can do this!

I already have a degree, why should I bother getting another one?

If your degree is already industry specific, then this probably isn’t right for you. But if your degree is in anything else, having a more specialised BSc that demonstrates specific industry knowledge can be a benefit.

Can I get my company to pay for me?

Absolutely! Some previous students have been able to secure part or full funding from their employer – lots of companies have a budget for external staff training so it’s definitely worth asking.

If your employer is willing to pay, you can let us know and we’ll sort out arranging payment from them directly.

But it’s worth pointing out that the majority of our degree students self fund the programme, seeing it as an investment in their career and as a gateway to higher future salaries.

I’ve looked at the topics and know lots of it already, can I skip ahead?

Nobody gets to skip ahead. This programme is about getting an academic award to recognise your industry knowledge. I’d expect you to know bits of it already but that just means you’ll be able to move through those topics quickly.

How often do degree programmes start?

There is only one intake into the BSc degree programme, every second January. The next intake for our BSc will be in January 2022.

If I want to start in January 2022, when do I need to have completed all my studies from eValidation/eBioPharmaChem?

If you wish to apply for the January 2022 BSc intake, all your previous studies need to be completed by August 2021 to allow time for your application to be processed.

When do applications open for the BSc intake?

For the BSc class starting in January 2022, applications will open in April 2021 and will close on the 1st of September 2021.

How do I apply for the BSc degree?

The first step will be to email us asking for the registration documents. At that time, we’ll talk you through the rest of the process but as a summary, you’ll need to:

Submit your CV in a standardised template
Complete a TU Dublin Registration form
Submit 2 passport photographs
Submit a scanned form of identification (e.g. passport or driver license)
Submit a scanned copy of your eBioPharmaChem and eValidation certificates
Submit copies of any other certificates or training courses you wish to include to support your application

All of this can be emailed back to us.

Once this has been submitted, GetReskilled will formally apply to TU Dublin for your place on the degree course.

The second step is to complete our Advanced Writing Skills course (at no additional cost). This will help make sure that you get the grades you deserve from all the hard work you put into your assignments and support you through the step up in assignment expectations moving to a BSc degree. This is a compulsory part of the application process.

Do I need to have specific grades in my earlier courses to be considered for a place on the BSc?

Yes. You need to have achieved a minimum of 50% in each module on your eBioPharmaChem and eValidation courses in order to be considered for a place. The programme committee will also look at your work experience and typically like to see that candidates have industry relevant work experience by the time of application.