Program Overview

Regulatory Affairs in Pharmaceuticals (Certificate, L9, 20 ECTS)

Course Overview

This programme in Pharmaceutical Regulations aims to provide learners with an understanding of EU, USA, and Other Jurisdictions regulatory systems in the pharmaceutical industry. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the world market. This programme will explore theory, regulations, tools, and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance, and operational standards in industry. Critical thinking, problem-solving, decision-making, professionalism, and management techniques will be key areas covered by the programme. This programme will enhance a learner's career in regulatory affairs by developing increasing levels of competence and professionalism and obtaining a formal qualification in the Pharmaceutical regulation industry.

Entry Requirements

• A minimum honours bachelor degree (Level 8) in any discipline with minimum two years, relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.
• A minimum ordinary bachelor degree (Level 7) in any discipline with minimum three years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.
• Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered.
• Recognised Prior Learning (RPL) – Assessment. Please review the academic entry requirements for this programme. If you do not hold these qualifications but would like your application to be assessed under RPL please select YES on the online application form. Once you have submitted your online application you will then receive an email acknowledgement with further instructions on RPL.

English Language Requirements

Applicants who do not have English as their first language must ensure they satisfy English Language requirements. For entry to undergraduate courses, a score of 5.5 in an IELTS or equivalent exam is required. For postgraduate courses, a score of 6.0 in an IELTS or equivalent exam is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements.

Course Content

Semester 1

• Regulatory Affairs (Pharmaceutical): Provide learners with an understanding of EU regulatory systems in the pharmaceutical field. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the EU market. This module will explore theory, regulations, tools, and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance, and operational standards in industry. This module will enhance a learner’s career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in the pharmaceutical regulation industry.

Semester 2

• Advanced Regulatory Affairs (Pharmaceutical): Understanding of the utilisation of standards, FDA and other jurisdictions’ guidance documents and technical writing. The module will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to Pharmaceutical in the world market.

Career Opportunities

• There are multiple roles a graduate from the programme can seek in areas such as Regulatory Engineer, Quality Engineers, Regulatory Affairs Management, Process Engineering Management, Compliance and Regulatory Management, Risk Management, etc.

International Opportunities

• The content of the modules will be seen to reflect a globalised environment. This is demonstrated by the regulatory affairs module stream which focuses on EU, US, and worldwide regulatory affair bodies.

Delivery

• Modules are to be delivered over one year in an online learning format.
• The indicative schedule for delivery is subject to change.
• 4 hours per week
• Number of Weeks: 12 per semester
• Number of Days / Evenings per week: 2
• Number of Hours per week: 4
• Delivery Day / Evening: see below
• Semester 1: September – December / Tue 7-10pm / Fri 1-2pm
• Semester 2: January – April / Tue 7-10pm / Fri 1-2pm

Time Commitment

• Each 5 credits will normally equate to approximately 100 Total Learning Hours. Total Learning Hours includes the time you spend in class (lectures, tutorials, practical elements) and the time you spend completing work outside of college. The balance between these two varies by discipline, and by level of study. You should bear in mind that the workload will increase at particular times e.g. when assignments are due.

Assessment

• Continuous assessment (100% online). No end of semester exams.

Qualification

• Certificate in Regulatory Affairs in Pharmaceuticals (Special Purpose Award, Level 9, 20 ECTS)

Fees

• €2,800

Application Deadline

• TBC for 2025

Places are allocated on a first come first served basis, prioritizing unemployed and returning applicants. Course will be closed once the maximum number of applicants is reached. Courses run subject to viable numbers.