Why was this course developed?
The South East region has a significant Life Sciences cluster, with c. 7,500 people employed and c. 1,700 new jobs projected over the next 3-5 years. There is a skills shortage at higher levels (Level 8-9) for expert scientists and technicians to perform formulation and other R&D activities. In response, companies are having to identify people within their organisations that can develop these skills, and are looking to work with SETU Waterford to put in place the training to upskill these key staff. The forecast growth in the sector in the South East is expected to make this shortage more acute and is creating an imperative to increase the numbers of people that are trained in these high-skill areas.
The Future Skills Needs of the Biopharma industry in Ireland report published in 2016 highlighted a need for advanced scientific skills at L8/L9. The National Skills Bulletin 2016 highlighted a shortage of Analytical Development Chemists, Formulation Scientists, R&D Scientists, and QC Analysts. The skills shortage in advanced formulation applies to approximately 15 companies (pharmaceutical companies in or moving to the region), who collectively require a skills pool of 40-50 formulation scientists. Allowing for promotions, retirements and people moving in and out of the region, it is estimated that there is a need to train at least ten people per annum to the level required.
On successful completion of this module, a student will be able to:
Appraise the principles of pharmaceutical/biopharmaceutical pre-formulation with respect to the overall design and development of drug delivery systems.
Evaluate how the physicochemical properties of drug molecules and excipients influence the choice of drug dosage form and subsequent formulation and manufacturing procedures.
Propose a formulation design and method of manufacture taking into account the physicochemical properties of drug molecules and excipients.
Establish method development strategies involved in lyophilisation, spray drying and aerosol drug formulation.
Produce a protocol for the stability testing of a pharmaceutical product
The Certificate in Advanced Drug Formulation Science programme is taught using a block approach on a part-time basis to facilitate students in full-time employment.
Over the duration of the programme, students will be required to attend SETU Waterford for 8 days.
In line with current education practice, the programme is designed to be learner-focussed and the teaching and learning strategy will involve the exposure of students to a wide range of learning experiences. They will be encouraged to reflect on their own learning experiences in lecture and practical sessions and to become self-directed learners.
Lectures will be used to introduce the concepts involved in Formulation Science as well as an in-depth investigation into the area. The inclusion of a significant practical element in the modules is carefully aligned with theory content. The practical element is scheduled to run after theory content has been delivered. Specific practical training will be given on formulation techniques by both lecturing staff and researchers in the Pharmaceutical & Molecular Biotechnology Research Centre (PMBRC).
Each student will have an individual project which will be based in SETU Waterford or possibly a host company (subject to approval by the company and SETU Waterford). The student will have to prepare a written report in advance of their laboratory work. This report will entail a high degree of self-directed learning and will involve research on a specific drug and dosage form. The student will be required to demonstrate a sound understanding of the formulation methodology with justification for the choice of excipients and manufacturing process. Additionally, a project plan will be submitted in advance of the practical with justification for the experimental design. The report for the practical will involve the student critically analysing the results of the experiments and drawing scientific conclusions.
Continuous assessment will be carried out throughout the course of the programme.
The Certificate in Advanced Drug Formulation Science is aimed at participants who are employed within the pharmaceutical and medtech companies, and who wish to upskill or seek employment in the formulation departments of such organisations.
Applicants for entry to this programme should hold a Level 8 Bachelor’s degree at honours level minimum 2.2 in an appropriate subject area or equivalent qualification.
Applicants whose first language is not English must submit evidence of competency in English, please see SETU Waterford’s English Language Requirements for details.
Where candidates do not currrently meet the formal academic entry requirements they may be able to advance their application using the Recognition of Prior Learning (RPL) mechanism. RPL allows candidates to make a case that they do meet entry requirements through a combination of formal certified learning and learning through (work) experience. RPL applications must be made by filling out (please type) the Springboard RPL form and submitting it along with supporting documents such as academic certificates and transcripts etc. Download the SETU Waterford Springboard RPL Form here https://www.setu.ie/images/uploads/Education_School_PDF/WIT_RP6_Springboard_RPL_Form.docx
This course places a strong emphasis on the professional development of the graduate and is aimed at students already working in an industrial environment. Such a qualification will enable and facilitate career progression for graduates in the region.
This programme can be taken as a stand-alone Certificate worth 10 credits at level 9, or if the student wishes, they can use these credits towards the 60 credit Postgraduate Diploma in Analytical Science with Quality Management (WD 519) or the 90 credit MSc in Analytical Science with Quality Management (WD 520).