Course Details

Course Code:
PDRABPTPBD
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 for more information or to be notified when applications are open.

Brief Description

Commencing in January 2023. Applications will open in September 2022.

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).

Download Brochure 

FOR WHOM

This Professional 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 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.  Learners will also develop their confidence and interview skills, as well as CV development and career development.

 

 

 

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

 

 

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).


- 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

 

For fees click here 

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

Please click here for information on funding and scholarships.