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Regulatory Affairs in (Bio)Pharmaceuticals - Professional Diploma

Course Details

Available: Part- Time

Duration: 1 year

Award: Professional Diploma

Qualification: NFQ Level 9 Minor Award

Faculty: Science and Engineering

Course Type: Professional/Flexible

Fees: For Information on Fees, see section below.

Contact(s):

Name:
Springboard
Email:
springboard@ul.ie
Express Interest

Register your interest here
to be notified when applications are open.

Brief Description

There is a strong demand in recent years for Regulatory Affairs (RA) professionals 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.

Applicants are encouraged to register and apply online via the Springboard website, see the apply now button above. 

This programme was developed with input from the Health Products Regulatory Authority and Solid State Pharmaceutical Cluster (SPCC).

FOR WHOM

This Specialist Diploma is available to graduates with a background in quality, manufacturing, pharmaceutical, biopharmaceutical or chemical sectors. It is for those with an interest in organisational improvement and development through the use of Regulatory Affairs tools and techniques. 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 five taught modules over two semesters. In addition to the taught modules, there will be a strong focus on the integration of the concepts, tools and techniques during the course of the programme. As well as the taught modules therefore, students will complete a project and a career development module. Course delivery combines traditional distance education with online learning and approximately three on-campus days per semester.

PARTICIPANTS LEARN TO

Understand both theory and practical application of RA tools and techniques to improve operational outcomes and efficiency. Apply RA methodology to help organisations improve performance and speed up the regulatory approval time. Each learner will participate in ‘Job Readiness’ & ‘Support into Employment‘ workshops, to develop their confidence and interview skills, as well as CV development and career development.

INDUSTRY LEARNING PROJECT

Industry representatives will engage in a series of presentations on employment opportunities in the region, as well as talks on specific RA topics from an industry perspective. In the second semester there will be the opportunity for course participants to apply for work placement with our industry partners. Students will complete a project focussing on the development of a plan to monitor and manage regulatory affairs compliance within an orgranisation

Spring Semester Autumn Semester
 
  • Drug Regulation & the Agencies
  •  RA Interactions in Drug Development & Product Marketing
  • Key Regulatory Considerations for Clinical Development and Operations
  • Career Development

 

 
  • Regulatory Requirements for New Active Substances
  • Regulatory Strategy & Requirements for Established Active Substances
  • Industry Learning Project

 

* 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. 

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.

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.)
- Photo or Scanned copy of passport to verify ID and full legal name.
- 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).

- Proof of Status, e.g. unemployed, employed, self employed, returners. Acceptable documents for proof of status can be found here https://springboardcourses.ie/eligibility
- 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

For more information Click Here

Springboard+

The fee for this programme is €5250

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

 

Employed

All employed participants must pay a contribution of the course cost directly to the provider for all level 7-9 courses. Please note some formerly self-employed applicants not in receipt on DEASP payment are liable for 10% fees also. The onus is on the participant to arrange payment of this fee. The HEA will fund the remainder of the cost directly to the provider.

Unemployed and Returner participants

Springboard+ will pay all fees for unemployed and returner participants.

 

To clarify eligibility please go to https://springboardcourses.ie/eligibility

 

Please note that Fees are subject to review

For information on funding and scholarships please click here.

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