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Code

SE51A

Location

Carlow

Campus

Kilkenny Road

  • Level Level 9
  • Duration 2 Years
  • Delivery Part-time
  • Applications Closing 30 Aug 2024
  • Fees View details
  • Application Status Open
  • Next Intake September 2024

Overview

The programme enables existingregulatory affairs personnel in thepharmaceutical regulatory industryto understand all current diagnosticand medical device regulations anddevelop the necessary skills to worksuccessfully in the dynamic world ofregulatory affairs.

What will I be able to do when I finish this programme?

On completion of this programme,students should be able to:

  • Devise and implement globalstrategies for drug, biologic, anddevice development and evaluation;
  • Apply principles of basic and appliedpharmaceutical sciences in drug andbiologics discovery and development.

What subjects will I study?

  • Lifecycle Management, Vigilance,Surveillance and Risk management
  • Pharmaceutical Technology RegulatoryAffairs
  • Non Clinical and Clinical Evaluation ofPharmaceutical Technologies
  • Principles of Discovery of Medicines andDevelopment Planning
  • Research Methods and Technical ReportWriting
  • Special Populations and Biologicals andAdvanced Therapies
  • Dissertation

Special Features of this programme

The primary objective of this Mastersis to enable learners to expand theirjob responsibilities and opportunitiesin new areas after completing theprogramme. It will also enable learnersto create an excellent network withinthe pharmaceutical industry, both bymeeting other regulatory professionalsduring the course and by interactingwith industry experts while completingtheir dissertation research.

Entry Requirements

A second-class honours degree in science, engineering, quality,pharmaceutical or regulatory affairs or cognate areas. Those failingto meet the classification requirement may be eligible for entry tothe Postgraduate Diploma.

Candidates with significant experience in: pharmaceutical operations,quality engineering, device design, mid to senior management inindustry, other professionals who wish to upskill in the regulatoryaffairs environment, regulatory affairs personnel themselves whowant to upskill (as determined by the Institutes recognition of priorlearning policy), in addition to an honours primary degree in anotherdiscipline area may also be considered for entry.

Study & Career Opportunities

Opportunities for graduates from this programme include progression to Level 10 (PhD) programmes in related fields of study.

According to a report from the ForfásExpert Group on Future Skills Needs,Ireland is emerging as a leadinglocation for biopharmaceuticals witha mix of start-ups, high growth SMEsand large multinationals located here.
Industry leaders including Pfizer, EliLilly, Sanofi, MSD (biologics basedin Carlow) and Alkermes plc. havesignificant investment in Irelandwhich has facilitated rapid growthand development of the industry.

These coupled with a stronggenerics industry (Wockhardt,Clonmel Healthcare both based inthe South-East) provide prospectiveemployment opportunities forgraduates and key engagementpartners for the programme.

More than 85 pharmaceuticalcompanies (including nine of thetop 10) operate over 100 facilities inIreland. The industry exports around$85 billion worth of products eachyear and is now one of the largestexporters of pharmaceuticals in theworld. This programme is designedto meet the growing demand forscientists to service the currentand emerging biotechnology-basedindustries in Ireland in particular, theSouth-East, Mid-East and Midlands.