Course Description

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.

CollegeWaterford Institute of Technology
Course LocationWaterford
Course CategoryHealthcare, Medicine & Healthcare
Course TypeClassroom Based
Course QualificationLevel 1 Certificate
Course Duration5 months Part-time.
Course FeePOA
Carear PathThe 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).
Course CodeWD583
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Waterford Institute of Technology
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