Professional Dip-Regulatory Affairs in (Bio)Pharmaceuticals

Course description

Award: NFQ Level 9 Minor Award

There is a strong demand in recent years for Regulatory Affairs (RA) professionals in Ireland at manufacturing or distribution sites within the pharmaceutical, biological, biopharmaceutical and chemical sectors. RA professionals carry out a pivotal role in the maintenance of compliance for the provision of safe and effective medicines.

This programme, offered by the Chemical Sciences Department in UL, is unique in that it is designed and delivered by Regulatory professionals.

This Professional Diploma is available for graduates with a background in quality, manufacturing, clinical, non-
clinical, pharmaceutical, biopharmaceutical or the chemical industry. It is for those For those with an interest in pharmaceutical development who wish to discover how medicines are licensed to get on the market and learn how to safeguard patients by ensuring safety, quality and efficacy of medicines on the market i.e. how medicines are regulated in Europe.

For graduates who would like to learn about the EU regulatory requirements, as well as the main features of the regulatory system in the US, which is the most important other jurisdiction for RA professionals based in Ireland.

This flexible programme lets students take six taught modules over two semesters. There is a strong focus on the integration of the concepts, tools and techniques learned during the course of the programme by use of case studies and group working, which really benefits student networking opportunities. Delivery will combine traditional distance education with online learning. There may be some on-campus tutorials per semester, (these will be on a Saturday).

Participants will learn to:

• Gain a solid understanding of what Regulatory Affairs is and its importance in the drug development process.
• Appreciate the impact a regulatory professional has on the development of innovative medicines.
• Learn about how medicines are regulated to ensure their safety and efficacy.
• Learn from experts, who are currently working in the field, about strategies to improve performance thus speeding up the regulatory approval time.
• Hear from speakers from Regulatory Authorities about how to improve the dossier to maximize the chance of success.
• Develop confidence and interview techniques, as well as CV development and career opportunities.

Funding:

Candidates who satisfy the eligibility criteria under Springboard+ can qualify for 90% or 100% funding subject to the availability of places.

Funding also available through BioPharmaChem Skillnet.