Why was this course developed?
The Certificate in International Regulatory Affairs 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 Certificate in International Regulatory Affairs was developed.
This course will provide the student with an understanding of the processes for providing regulatory support to the facility ensuring compliance with ICH. EMA and FDA legislation. The course will also describe the mechanisms for bringing a new medicinal entity for human use to market, to obtaining marketing authorisations, to maintaining 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.
This course will also provide the student with an advanced understanding of the procedures involved in the regulation of pharmaceutical products in the EU, US and other markets. The structure and role of US, European and other regulatory authorities will be studied. Harmonisation of standards in the pharmaceutical industry and the various licensing routes for drug products in the EU will also be objectives of the course. The learner will be exposed to the interface between regulatory affairs and operations. Pharmacovigilance and the pharmaceutical inspection convention will also be emphasised throughout the course of the programme.
What are the learning outcomes?
On successful completion of this module, a student will be able to:
- Evaluate legislation and regulations governing the pharmaceutical and medical device industry to ensure compliance with regulatory requirements.
- Compile regulatory documentation in a format for submission to authorities in EU/US/Japan (Common Technical Document) applications and maintenance.
- Critically evaluate various licensing routes in the EU and develop a strategy for submission and maintenance of marketing authorisations.
- Recognise the roles of the various regulatory agencies including EDQM, EMA and National Competent Authorities.
- Implement a pharmacovigilance system in compliance with the regulations.
- Assess the regulations and specific commitments to agencies to ensure compliance between regulatory affairs and operations.
Cost
The course is 90% funded by Government for employed people who will pay 10% of the total programme fee - please reference www.setu.ie/springboard .
The course is fully funded for unemployed people and people returning to formal employment - please see http://springboardcourses.ie/eligibility
10% fee payable by employed people: €99
Delivery Method
- The course will be delivered 100% online and will run once per month, over two full days on a Friday and Saturday (Jan to April'2024)
- Friday 12th & Saturday 13th January'2024
- Friday 9th & Saturday 10th February'2024
- Friday 8th & Saturday 9th March'2024
- Friday 12th & Saturday 13 April '2024
How is this course delivered?
The indicative delivery model for the Certificate in International Regulatory Affairs (Postgraduate) module for the 2023/24 academic year is that the course will be delivered via blended delivery: January to May 2024. Two days per month, 2 full days on the SETU Waterford campus will be required with the remainder of the classes taking place on-line.
Dates to be confirmed.
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 in relation to their own experience in the context of their working environment.
Continuous assessment will be carried out throughout the course of the programme.
The Certificate in International Regulatory Affairs is aimed at participants who are employed within the Regulatory or Compliance functions of pharmaceutical and medtech companies, and who wish to upskill or seek employment in the regulatory departments of such organisations.
International Regulatory Affairs Entry Requirements
- Applicants for entry to this programme should hold a Level 8 Bachelor’s degree at honours level minimum 2.2 in an appropriate subject area or equivalent qualification.
- Applicants whose first language is not English must submit evidence of competency in English, please see SETU Waterford’s English Language Requirements for details.
This course places a strong emphasis on the professional development of the graduate and is aimed at students already working in an industrial environment. Such a qualification will enable and facilitate career progression for graduates in the region.
Further study opportunities
This programme can be taken as a stand-alone Certificate worth 10 credits at level 9, or if the student wishes, they can use these credits towards the 60 credit Postgraduate Diploma in Analytical Science with Quality Management SE51H /SE51J or the 90 credit MSc in Analytical Science with Quality Management SE51H /SE51J
This course places a strong emphasis on the professional development of the graduate and is aimed at students already working in an industrial environment. Such a qualification will enable and facilitate career progression for graduates in the region.
Further study opportunities
This programme can be taken as a stand-alone Certificate worth 10 credits at level 9, or if the student wishes, they can use these credits towards the 60 credit Postgraduate Diploma in Analytical Science with Quality Management SE51H /SE51J or the 90 credit MSc in Analytical Science with Quality Management SE51H /SE51J
