Andrea Mallia-Milanes was recently awarded a Doctor of Philosophy (Pharmacy) from Cardiff University.
Her research focused on the quality management systems and performance of major international pharmaceutical companies and regulatory authorities.
The innovative aspect of her work was the development and testing of scorecards to assess the quality of the technical content of dossier applications, the consistency of the regulatory review, professionalism and scientific competence, the level of interface between industry and the regulators, as well as the degree of transparency.
The research demonstrated the validity and applicability of the scorecards in the systematic evaluation of the quality of submissions and their review. The routine use of these scorecards should contribute to greater transparency leading to an improvement of the regulatory environment.
In 2007, Dr Mallia-Milanes was awarded first prize for a poster presentation on this work at the 43rd annual meeting of the Drug Information Association held in Atlanta, US.
Dr Mallia-Milanes graduated from the University of Malta in 1998 with a Bachelor of Pharmacy (Hons) degree. She was also awarded the degree of Master of Philosophy in 2006 from Cardiff University.