Regulatory Affairs and (Bio)Pharmaceutical Data Integrity
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Course Overview
The development and production of (bio)pharmaceuticals occurs under the strictest of legislative and scientific frameworks. As such, procedures, systems and methodologies must be utilised and understood to ensure the highest of data integrity standards. Students will gain in-depth knowledge of the important role that Good Manufacturing Practice (GMP), Quality systems and regulatory bodies play in the lifecycle of a new drug candidate through to a commercial finished product. This module will enable candidates to objectively and rigorously assess dataset quality and integrity and see data as a valuable asset and how it should be protected/secured.
Understanding the Industry
Industry has highlighted through SECBA project engagement that there is a significant need for specialised expertise in many fields such as bioinformatics, analytical chemistry and biotechnology. Quality assurance and control are particularly crucial, with industry seeking competent analysts, Qualified Persons (QPs), and professionals skilled in Quality Management Systems (QMS) and ISO standards.
The growing reliance on technology, including computerised information management, automation and digital skills like bioinformatics and statistical analysis, further underscores the need for graduates with strong tech proficiency. Regulatory compliance, especially in Quality Control, validation, and adherence to standards, is also a priority. However, a noticeable talent gap exists, particularly for roles requiring specialised skills (e.g. Bioprocessing). This highlights the importance of ongoing education and training in related fields to address the skills shortage and ensure a steady pipeline of qualified professionals for the sector.
Career Opportunities
This programme aims to help science, engineering and related graduates to re-skill or up-skill with the required knowledge and skills to assist them in gaining employment in the (Bio)pharmaceutical, Biotechnology, Manufacturing, Medical Devices, Healthcare and related Life Science industries.
Learners could gain employment within the sector (e.g. Wu-Xi Biologics, Pfizer, Almac, MSD, AbbVie, Grifols, Amryt Pharma etc.) and undertake the programme to obtain a recognised qualification.
Some learners may undertake the programme to ‘re-skill’ and move into the area, they are not employed, or perhaps employed in other Biopharmaceutical areas.
Course Delivery and Modules
This course will be delivered using a combination of online and face-to-face (labs), delivered over one semester.
Online Lectures typically take place on Tuesdays and Thursdays with designated lab days scheduled at the end of the semester.
Module Learning Outcomes
- Evaluate the use of current Good Manufacturing Practice (cGMP), Quality Control/Quality Assurance (incl. quality management software) and evaluate their importance in the (bio)pharmaceutical industry
- Compare and contrast international legislation and the role of regulatory authorities in evaluating and approving (bio)pharmaceutical drug candidates/drug products, to include regulation/guideline harmonisation across regions.
- Evaluate and interpret pharmacovigilance, GVP (Good PharmacoVigilance Practices) and risk management plans for new (bio)pharmaceutical drug products
- Evaluate the importance of data integrity within the (bio)pharmaceutical industry, from early stage development through to routine commercial batch production and release
- Use descriptive statistics to characterise and validate datasets. Identify outliers in a dataset and set up warnings/flags when data breaches predefined working
- cGMP and Quality systems
- GMP and Quality management, Quality systems to include; Self Inspections and Auditing, QC functions (i.e. types of testing laboratories). The role of GMP and QA in the discovery, testing, marketing and postmarketing of new (bio) pharmaceutical drugs / drug candidates. How developing technologies (e.g. AI, LIMS) can be implemented to improve quality processed.
- Overview of the role and remit of Regulatory Authorities and value of bodies of international standards cooperation (e.g. ICH)
- Review of the FDA (USA), EMA (EU) and HPRA(Ire): Structure and mission, role in the (bio)pharmaceutical drug development and approval process.
- Drug distribution and drug marketing authorisations (incl. IND & NDA applications).
- Importance and scope of Regulatory audits in the (bio) pharmaceutical industry.
- Development of generic drug products and regulatory pathways followed.
- Good Pharmacovigilance Practice
- Understand the basis of pharmacovigilance, reporting channels, necessity of risk management plans, recalls and complaints procedures and pharmacovigilance inspections.
- (Bio)pharmaceutical data integrity
- Importance of data integrity within industry. Key principles promoting data integrity (ALCOA+), consequences of poor data integrity. How developing technology can be implemented to improve data integrity processes.
- Fundamental Analytics Skills
- Understand statistical terms and concepts, data types & importing, Data & Tables, Visualising data (e.g. Graphing, Line & Scatter Plots, Histograms, Analysing & Interpreting), Descriptive & predictive statistics, Outlier identification & Flags/Warnings
Education Progression
Graduates may progress to the Higher Certificate/ Diploma in Science in Biopharmaceutical Manufacturing or similar level 8 programmes. Graduates of the Higher Diploma will be able to progress to level 9 taught postgraduate and Level 9 and 10 research programmes, including Level 9 and 10 research opportunities in DkIT.
Certificate in Science in Biopharmaceutical Manufacturing New course
Higher Diploma in Science in Biopharmaceutical Manufacturing
Fees and Funding
This programme is funded through the South East Cross Border Alliance (SECBA) project, supported by PEACEPLUS, a programme managed by the Special EU Programmes Body (SEUPB).
Fees
Entry requirements
Standard Entry Requirements
- Applicants should have a level 8 major award in Engineering / Science (or equivalent)
or - a Level 7 award in a cognate Science discipline (or equivalent)
or - a Level 7 award in Engineering with a minimum of 2 years’ experience in the Pharmaceutical / Biopharmaceutical Industry (or equivalent)
- Applicants for whom English is not their first language must have English level of IELTS 6.0 or equivalent.
Non-Standard Entry Requirements
Any non-standard entries will be covered by Recognition of Prior Learning.
The part-time programmes are not available to international applicants (the programme includes delivery of practical content on campus, part-time programmes do not fulfil visa requirements).
Recognition of Prior Learning
Applicants who do not meet the standard academic entry requirements but have significant relevant experience (certified and/or experiential) may apply to access this programme via the Recognition of Prior Learning (RPL) route. Learn more about RPL at DkIT
How to apply
Applications will open soon. Register your interest below and we’ll notify you once they open.
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Disclaimer: All module titles are subject to change and for indicative purposes only. All courses are delivered subject to demand and timetables are subject to change. Elective Module options will only run subject to student numbers. The relevant Department will determine the viability of each elective module option proceeding depending on the number of students who choose that option. Students will be offered alternative elective modules on their programme should their preferred elective option not be proceeding. Award Options for Common Entry Programmes: The relevant Department will determine the viability of each award option proceeding depending on the number of students who choose either option. If the numbers for one of the Award options exceed available places, students for this option will be selected based on Academic Merit (highest grades).