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.

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

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.

1 year part-time, on-line

Spring