Nancy Pire-Smerkanich is Assistant Professor, Department of Regulatory and Quality Sciences, at University of Southern California School of Pharmacy, US. She is a member of the TOPRA Editorial Board.
Setting the right standards
The theme of this issue is Global Standards but – as the contents reflect – the process by which documents and data become ‘standardised’ is anything but homogeneous or harmonised.
Adapting, transforming and innovating
For the past two years, global regulatory authorities have faced an un usual set of circumstances – navigating a pandemic while simultaneously producing more advice, guidance and regulations than ever be fore. The COVID-19 pandemic forced authorities to introduce new processes very quickly, and work closely with other authorities, public ...
The power of collaboration
Katherine Tyner, FDA Liaison to the EMA, Office of Global Policy and Strategy, FDA, discusses her position as a primary point of contact between the world’s two most important Agencies, and the goals they share for the future of public health.
Data governance as a strategic imperative for regulatory compliance
Data governance is a multi-faceted arrangement that relies on data quality, data integrity, data and document management, security and safe storage. It is critically important to companies and regulators as they evaluate product quality, the manufacturing process and the reliability of study data from non-clinical and clinical research. The integrity ...
What does 2022 have in store for clinical trials?
Although the pandemic is not over yet, as we move forward, we must embrace these advances and not return to ‘business as usual’ despite the challenges such ways of working entail