The PRST at DIT is engaged in Regulatory Science education and research for the pharmaceutical and medical device industry to enable those involved in the development, manufacture and supply of drug and related health products to deliver safe and effective products for patients and to meet the expectations of the international regulatory community.
We actively engage with industry, regulators and academics in order to focus on addressing the challenges and opportunities of implementing Science and Risk based manufacturing approaches.
For the past 30 years, the increasing demands to protect public health and ensure high quality, safe and effective medicines has driven the development of the regulations and guidance associated with Good Manufacturing Practice (GMP). Between 2005 and 2009 the International Conference of Harmonisation (ICH), which brings together the drug regulatory authorities of Europe(EU), Japan (MHLW) and the United States(FDA) and the pharmaceutical industry , published three important harmonized guidance documents referred to as ICH Q8R2, Q9 and Q10 which outline the international regulatory communities position on;
This regulatory initiative has formalized the quality paradigm shift in the industry regarding the necessary application of sound science and quality risk management principles to promote modern manufacturing techniques, process improvement and continual innovation.
The principles of this paradigm shift have been outlined in the ICH concept of Quality by Design (QbD). QbD promotes
The work of the PRST is responding to this quality paradigm shift through the development of solutions, such as;
This work aims to address the FDA's main message from its strategy document published Aug 2011 on 'Advancing Regulatory Science at FDA' that;