Course Details
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Brief Description
Funded places are offered on a first-come first-served basis, but these are limited and are strictly subject to Springboard+/HCI eligibility. Once the funded places have been filled, the course may remain open for those who wish to apply for a self-financed place.
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, is unique in that it is designed and delivered by Regulatory professionals.
Applicants are encouraged to register and apply online via the Springboard website, see the apply now button above.
FOR WHOM
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.
HOW IT WORKS
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 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.
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Spring |
Drug Regulation & the Agencies The aim of the module is to introduce participants to the legal basis for the regulation of medicines in the bio/pharmaceutical industry. The module with teach delegates how to improve their interactions with the Regulatory Authorities and how to follow and interpret the current legislation |
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Regulatory Affairs Interactions in Drug Development & Product Marketing The aim of this module is to inform students about the importance of the regulatory function in terms of the interactions in drug development and product marketing. The tutors will provide the participants with a thorough overview of the importance of IPHA (The Irish Pharmaceutical Healthcare Association) to the pharmaceutical industry in Ireland. Students will be informed about the fundamentals of pharmaceutical development (traditional and biotech) |
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Key Regulatory Considerations for Clinical Development and Operations The aim of the module is to introduce participants to clinical and non-clinical development and to give a grounding in the legal framework for clinical trials in the EU. Students will learn about the necessity for developing a solid global regulatory strategy in advance of and in conjunction with the pharmaceutical development programme. The global regulatory environment for pharmaceutical development will be discussed and explored. Students will get a thorough grounding in the design of clinical trials. |
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Autumn |
Regulatory Requirements for New Active Substances The aim of this module is to introduce participants to the world of quality in the pharmaceutical industry and to understand the structure and content of the Common Technical Document (CTD)/Marketing Authorisation Application (MAA). The practical aspects of the role of Quality in industry is covered from the perspective of 'big' pharma. The EU filing procedures, namely, the Mutual Recognition Procedure (MRP), the Centralised Procedure (CP) and the Decentralised Procedure (DCP) are explained. Practical issues associated with Inspections, working both in the EU and the US are explained. |
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Regulatory Strategy & Requirements for Established Active Substances The aim of this module is to develop participants knowledge of the regulatory strategy requirements for established active substances. This module will cover generic/biosimilar. This module will also cover lifecycle maximization through supplementary filings/abridged applications. EU Innovations for licensing will be taught. Additionally, the similarities and differences between the EU and US regulatory systems will be reviewed. The legal framework will also be presented. |
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Employment Enhancement (no credits) The programme tutor will bring in HR expertes from the Regulatory Affairs Biopharmaceutical sector to speak with students about possible careers in the area. |
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Springboard funded students can avail of the following optional modules:
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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.
What to Include with your Application
Delays in receiving these documents will affect the progress of your application.
- Photo or Scanned original copy of your transcripts for all years of study. (Graduates of UL need only provide us with their Student ID number)
- A copy of your birth cert or passport
- A copy of your most recent CV, (for Springboard+ applicants, please note that by providing this document you are agreeing that we may send it to members of industry if you require assistance when searching for an Industry Learning Placement (ILE) or project work. Applies to some courses only)
- Applicants who do not have English as their first language may satisfy English Language requirements:
- If your qualifications have been obtained in a country where English is an official language this will suffice
- If this is not available, the following additional documents must be provided:
- English translation of your qualification(s)/transcripts AND
- English language competency certificate
- Please click here for Further Information on English Language Requirements
The fee for this programme is €6,500 per annum (EU and NE)
Further information on fees and payment of fees is available from the Student Fees Office website. All fee related queries should be directed to the Student Fees Office (Phone: +353 61 213 007 or email student.fees.office@ul.ie.)
Springboard - Candidates who satisfy the eligibility criteria under Springboard+ can qualify for 90% or 100% funding subject to the availability of places. To clarify eligibility please go to https://springboardcourses.ie/eligibility