Regulatory Affairs in BioPharmacheuticals

Key programme benefits to future students
Students will gain a solid understanding of what Regulatory Affairs is and its importance in the drug development process.

Students will learn from experts, who are currently working in the field, about strategies to improve performance thus speeding up the regulatory approval time.

Students will learn about how medicines are regulated to ensure their safety and efficacy.

Spring Modules
• Regulatory Requirements for New Active Substances
• Regulatory Strategy & Requirements for Established Active Substances
• Employment Enhancement

Summer Modules
• Drug Regulation & the Agencies Regulatory Affairs
• Interactions in Drug Development & Product Marketing
• Key Regulatory Considerations for Clinical Development and Operations

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.)
- 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

Preparing your Application:
1. Research your programme: Each postgraduate programme at University of Limerick is unique. Explore your course content, duration, fees, and entry requirements on ul.ie.

2. Check Eligibility: Ensure that you meet the eligibility criteria for the course you are interested in. This usually includes your undergraduate degree award, subject specialities, English language proficiency (for non-native speakers), and any specific requirements for the course.

3. Prepare Documents: Gather all the necessary documents. This typically includes your academic transcripts, CV, personal statement, and references. If English is not your first language, you’ll also need to provide evidence of your English language proficiency.

4. Online Application: Once you are ready to apply, visit your postgraduate programme page on ul.ie/gps and use the Apply Now button to access UL’s online application system. You will need to create an account if you are a new user.

5. Complete the Application: Fill in the application form with all the required details. This will include personal information and academic history.

6. Upload Documents: Upload all the necessary documents that you prepared earlier. Make sure they are clear and legible.

7. Submit Application: Review your application thoroughly to ensure all information is correct and then submit your application. The application fee for your postgraduate application is €50. This includes an option to choose a second choice.

8. Track Your Application: After submission, you can track the status of your application through the online application system.

9. Interview: Depending on the programme, you may be invited for an interview. This could be in person or online.

10. Acceptance: If your application is successful, you will receive an offer email from the university. You will need to accept this offer to secure your place.

Applications are reviewed on a rolling basis and places offered to successful candidates. This means that it’s a good idea to apply as early as possible to increase your chances of securing a place.

Please note that these steps are a general guide and the exact process may vary depending on the specific programme and your individual circumstances. Always check the University of Limerick website or contact the postgraduate admissions department for the most accurate and up-to-date information.

1 year part-time, on-campus.

Spring