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International Regulatory Affairs

The Postgraduate Certificate in International Regulatory Affairs is aimed at participants who are employed within the Quality functions of pharmaceutical and healthcare companies, and who wish to upskill or seek employment in the regulatory departments of such organisations.

The programme will provide participants with an understanding of the processes for providing regulatory support to the facility ensuring compliance with ICH, EMA and FDA legislation.

The programme will also describe the mechanisms for bringing a new medicinal entity for human use to market, to obtain marketing authorisations, to maintain the drug authorisation process through the variations process, and post marketing surveillance strategies to ensure that market vigilance is maintained after the medicinal product has been launched and becomes a commercial entity.

On successful completion of this module, a student will be able to:
1.Evaluate legislation and regulation applied to implement systems within the pharmaceutical and healthcare industries to ensure compliance with regulatory requirements.

2.Construct regulatory documentation in a format for submission to authorities in EU/US/Japan (Central Technical Document).

3.Critically evaluate various licensing routes in the EU and develop a strategy for the most efficient procedures.

4.Assemble and integrate harmonised standards in marketing authorisation management in the pharmaceutical industry.

5.Ascertain the role of the European Directorate for the quality of medicines in pharmaceutical assessment certificates of suitability.

6.Research, revise, evaluate and synthesise information and present it in the required written format for regulatory submissions.

Special Feature:
The Postgraduate Certificate in International Regulatory Affairs can be taken as a stand-alone module worth 10 credits at level 9, or if the student wishes, they can use these credits towards the Postgraduate Diploma/MSc in Analytical Science with Quality Management (WD 519/520).

Wales Ireland Network for Scientific Skills (WINSS)
This programme was developed following a Scientific Skills Survey which was conducted by Wales Ireland Network for Scientific Skills (WINSS) to address the scientific skills gaps within industries based in Dublin, Meath, Kildare, Waterford, Kilkenny, Wexford, Wicklow, Carlow, South Tipperary, Cork and Kerry.

The survey was sent to more than 100 companies in the pharmaceutical/biotechnology, medical device and food sectors. Regulatory Affairs was highlighted as one of the deficit areas in the pharmaceutical and medical device sector from the survey and as a direct result, the part-time Postgraduate Certificate in Regulatory Affairs was developed, along with the overarching Postgraduate Diploma/MSc in Analytical Science with Quality Management (WD 519/520).

Entry requirements

• Applicants for entry to this Postgraduate Certificate course should hold a bachelor's degree at honours level minimum 2.2 (Level 8) in an appropriate subject area or equivalent qualification.

• In addition, in order to fully appreciate the industrial impact of the quality content of this programme, it has been deemed necessary to have a minimum of two years relevant industrial work experience.

• Applicants whose first language is not English must submit evidence of competency in English, please see WIT’s English Language Requirements for details.

Duration

5 months Part-time.

• The certificate programme will be taught using a block approach on a part-time basis to facilitate people in full-time employment.

• Over the duration of the programme, students will be required to attend WIT for approxiamately 8 days from January - May. Typically, this would involve four two-day sessions on campus.

Number of credits

10

Careers or further progression

The postgraduate certificate programme can be taken as a stand-alone module worth 10 credits at level 9, or if the student wishes, they can use these credits towards the Postgraduate Diploma/MSc in Analytical Science with Quality Management (WD 519/520).

Further enquiries

Course Leader
Dr. Kathleen Grennan
BSc PhD - Lecturer
Phone: +353 51302047
Email: kgrennan@wit.ie

Subjects taught

• The programme contains a blend of lectures, tutorial sessions, which will involve group discussions, and independent study.

• Lectures will be used to introduce the concepts involved in International Regulatory Affairs as well as an in-depth investigation into the area. Additionally the core concepts behind legislation and regulation in the pharmaceutical and healthcare industries will be detailed in lectures, while tutorial sessions will also be used to share practical information.

• These complementary teaching and learning strategies will allow each student to apply what they have learned to an industrial setting and use teamwork, problem solving and brainstorming to critically engage with the subject, actively engage in troubleshooting and propose strategies for solving problems. The students will also be required to learn from discussions with one another and give examples with relation to their own experience in the context of their working environment.

• On a long-term basis, some of this material may be developed in an e-learning capacity to facilitate distance learning.

Assessment method

Continuous assessment will be carried out throughout the course of the programme.

Enrolment and start dates

The course will be offered every two years. The course will run in January 2017, subject to sufficient numbers of students.

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