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.
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).