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.