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 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.
This programme will provide the student with an advanced understanding of the procedures involved in the regulation of pharmaceutical products and medical devices in the European Union, 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 programme. 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:
1.Evaluate legislation and regulations governing the pharmaceutical and medical device industry to ensure compliance with regulatory requirements.
2.Compile regulatory documentation in a format for submission to authorities in EU/US/Japan (Common Technical Document) applications and maintenance.
3.Critically evaluate various licensing routes in the EU and develop a strategy for submission and maintenance of marketing authorisations.
4.Recognise the roles of the various regulatory agencies including EDQM, EMA and National Competent Authorities.
5.Implement a pharmacovigilance system in compliance with the regulations.
6.Assess the regulations and specific commitments to agencies to ensure compliance between regulatory affairs and operations.
How is this course delivered?
•The Certificate in International Regulatory Affairs programme is taught using a block approach on a part-time basis to facilitate students in full-time employment.
•Since this course is also offered as one module of the two year MSc in Analytical Science with Quality Management programme, the Certificate in International Regulatory Affairs is only offered once every two years. The course will next run in January 2019, subject to sufficient student numbers.
•Over the duration of the programme, students will be required to attend WIT for 8 days. The delivery dates for the 2018-19 academic year are as follows:
Friday and Saturday 25 & 26 January 2019
Friday and Saturday 08 & 09 February 2019
Friday and Saturday 08 & 09 March 2019
Friday and Saturday 29 & 30 March 2019
•The programme contains a blend of lectures, tutorial sessions, which will involve group discussions, and independent study. Students are required to attend WIT for all classes.
•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.