Regulatory Affairs in (Bio)Pharmaceuticals - Professional Diploma Programme content
Boost your pharma career with UL’s online Professional Diploma in Regulatory Affairs. Gain EU and global expertise and 30 ECTS towards a Flexible Masters.
Key information
EU fees per year
€6,500
Non-EU fees per year
€6,500
NFQ Level
NFQ Level 9 Minor
Duration
One year
Attendance
Part-time
Programme type
Taught, Professional / Flexible
Delivery
Blended
Start date
January
Award
Professional Diploma
Key information
- Complete part-time in one year
- Blended delivery – online lectures and one on-campus day each semester.
- On-campus day typically held on a Saturday and are not obligatory to attend.
- Online classes are typically delivered on a Monday evening from 7- 9pm and are recorded.
- Modules taught during spring and autumn semesters
- Can be used to complete 30 credits towards Master of Professional Practice (MPP) or MSc Engineering Practice.
You will learn through a blend of
- Lectures, project-based learning (PBL) workshops, and experiential learning
- Reflective practice and supervised research
- Regular feedback from faculty and peers through group work and assessments
Programme content
Core modules
- Drug Regulation & the Agencies (BC5002) introduces the legal basis for medicine regulation in the (bio)pharmaceutical industry and teaches how to interpret legislation and engage effectively with regulatory authorities.
- Regulatory Affairs Interactions in Drug Development & Product Marketing (BC5012) explores the regulatory role across drug development and marketing, covering codes of practice, fundamentals of traditional and biotech development, and key interactions with pharmacovigilance and medical information functions.
- Key Regulatory Considerations for Clinical and Noon-Clinical Development and Operations (BC5022) provides an overview of clinical and non‑clinical development, EU clinical trial legislation and documentation, trial design fundamentals, scientific advice, and strategies for building a global regulatory plan.
Relevant course materials - such as books and journal articles - will be available digitally via the UL Glucksman Library’s online resources.
For more information on each module, you can search the faculty, school and module code on UL’s Book of Modules.
Core modules
- Regulatory Requirements for New Active Substances (BC5001) covers quality and CMC requirements, the structure and content of CTD/MAA dossiers, EU filing procedures (MRP, CP, DCP), and practical considerations for inspections in both EU and US contexts.
- Regulatory Requirements for Established Active Substances (BC5011) focuses on regulatory strategies for generics and biosimilars, lifecycle management through variations and renewals, EU innovations and legislative reforms, and comparisons between EU and US systems. Includes career insights from industry experts and a forward‑looking session on the future of pharmaceuticals.
- Employment Enhancement – career development (no credits) Provides career development support through sessions with HR and industry experts, focusing on integrity, negotiation, leadership, confidence building, and practical guidance on CVs and interview techniques.
Relevant course materials - such as books and journal articles - will be available digitally via the UL Glucksman Library’s online resources.
For more information on each module, you can search the faculty, school and module code on UL’s Book of Modules.
Area(s) of interest
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