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Regulatory Affairs in Pharmaceuticals (L9, 20 ECTS)
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Status: Closed
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Campus: Online
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weeks: 24
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Fees: €2,800
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 learners career in regulatory affairs by developing increasing levels of competence and professionalism and obtain a formal qualification in the Pharmaceutical regulation industry.
This Graduate Certificate of Science is delivered on line and designed as part of an innovative multi- tiered programme to address the needs and requirements of industry-based learners and making education more accessible. It is designed so that learners can opt to select the module streams individually as Special Purpose Awards, complete three of the module streams to attain a Level 9 Graduate Diploma or opt for the Level 9 Masters of Science
The course will provide students with critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.
Contact Details
What are the entry requirements?
(a) 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
Or
(b) 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
Or
(c) Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered.
Recognised Prior Learning (RPL) / Special Case Registrations: Prospective applicants who do not meet the entry requirements for the programme detailed above, but who may qualify for admission by meeting certain other equivalent criteria, should submit their application online, upload their most relevant qualifications and then email Flexible.midwest@tus.ie to request RPL consideration.
ENGLISH LANGUAGE: Applicants who do not have English as their first language must ensure they satisfy English Language requirements. For entry to undergraduate courses, a minimum score of 5.5 in an IELTS exam is required. For postgraduate courses, a minimum of 6.0 is required. It is the responsibility of the applicant to ensure their English proficiency meets these requirements.
Module Outline
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Regulatory Affairs (Pharmaceutical) – Tuesday 7pm – 10pm
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.
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Advanced Regulatory Affairs (Pharmaceutical) – Tuesday 7pm – 10pm
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.
More Information
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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 offered by Programme:
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.
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Tuesday / 7pm to 10pm / 24 Weeks
Number of Weeks: 24 (12 per semester)
Number of Days/Evenings per week: 1
Delivery Day/Evening: Tuesday (Semester 1 & 2 )
Number of Hours per day/evening: 3
Times: 7pm to 10pm
Lectures will be delivered 100% online via Moodle/MSTeams. Lectures will be recorded and available to watch back.
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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.
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As assessments will be 100% Continuous Assessment and mainly industry based, learners are required to engage with industry and industry representatives in various cross disciples through continuous assessment and industry-based projects. This will prepare learners to be industry ready and apply the transferable skills gained through module content, industry engagement, and strengthened by industry-based assessments.
Students will be assessed on their learning by a variety of strategies including:
- The use of continuous assessment through projects, coursework, multiple choice questions, e-tivities, presentations and assignments. 100% Continuous assessment i.e., NO terminal examinations.
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Certificate in Regulatory Affairs in Pharmaceuticals (Special Purpose Award, Level 9, 20 ECTS)
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€2,800
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TBC