
University of Limerick
Regulatory Affairs in BioPharmacheuticals
Key programme benefits to future students
Students will gain a solid understanding of what Regulatory Affairs is and its importance in the drug development process.
Students will learn from experts, who are currently working in the field, about strategies to improve performance thus speeding up the regulatory approval time.
Students will learn about how medicines are regulated to ensure their safety and efficacy.
Subjects taught
Spring Modules
• Regulatory Requirements for New Active Substances
• Regulatory Strategy & Requirements for Established Active Substances
• Employment Enhancement
Summer Modules
• Drug Regulation & the Agencies Regulatory Affairs
• Interactions in Drug Development & Product Marketing
• Key Regulatory Considerations for Clinical Development and Operations
Entry requirements
Programme participants should hold a NFQ level-8, primary honours degree or an equivalent qualification and ideally have at least two years of relevant work experience. Where an applicant does not meet the entry requirements above, they can be evaluated under the UL RPL (prior learning) policy and may be interviewed to ascertain their suitability for the programme.
Duration
1 year part-time, on-line
Enrolment dates
Spring
More details
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Qualifications
Minor Diploma (Level 9 NFQ)
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Attendance type
Part time
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Apply to
Course provider