Regulatory Affairs (Bio) Pharmacheuticals
There is a strong demand in recent years for Regulatory Affairs (RA) professionals within the biopharmaceutical and pharmaceutical industries. RA Professionals carry out a pivotal role in ensuring the provision of safe and effective medicines.This flexible Specialist Diploma is available to graduates with a background in medicine, pharmacy, biotechnology, pharmaceutics or other science related discipline or for those who may have a background in clinical research, quality, compliance or manufacturing in the pharmaceutical industry. It is for graduates who would like to learn about the regulation of medicines and the impact and need for their regulation. This course allows students to take five taught modules over two semesters. There is an additional mandatory career development module. In addition to the taught modules, there will be a strong focus on the integration of the learning during the course of the programme, through multiple choice questions, case studies, essays and assignments.
Entry requirements
Programme participants should hold a NFQ level-8, primary honours degree or an equivalent qualification and have at least five 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.
Subjects taught
Semester 1
• Drug Regulation and the Agencies
• Regulatory Affairs Interactions in Drug Development and Product Marketing
• Key Regulatory Considerations for Non-Clinical and Clinical Development and Clinical Operations
Semester 2
• Career Module, including, interview /CV skills, leadership, confidence and integrity, negotiation and presentation skills.
• Regulatory Requirements for a New Active Substance: Chemical and Pharmaceutical
• Regulatory Strategy and Requirements for Established Active Substances
Duration
1 year part-time Blended
Post Course Info
Career Development
Industry Presentations on Current Activity in Ireland and Future Potential in the sector
Employer Open Days
Presentation Skills Workshops
CV Preparation
Confidence, Motivation & Job Readiness Workshops
* The number of in-company work placements offered depends on the student's location, topic area and motivation to participate in all elements of the course. A work placement manager will work with participants and companies to find the best fit but the onus is on the learner to play an active role in this process.
