The poster “Remote GLP Study Inspections: From an Integration Tool for People with Physical Disability towards an Opportunity for COVID-19 Pandemic Disruption” by the UTOX-PCB, QAU-GLP-PCB and SQR-UB team, presented by Carme Navarro, received the “Best Poster Award” at the 37th US Society of Quality Assurance (SQA) Annual Meeting. The award recognised the value of the tool to help people with limited mobility integrate and deal with contingency situations such as the COVID-19 pandemic.

Basic research conducted by many teams from universities, scientific and technological parks, and public institutes, as well as spin-offs, start-ups, SMEs and large companies, requires support from advisors and contract research organisations (CROs) to develop a preclinical and clinical programme, if applicable, to evaluate the safety of test products before registering them and placing them on the market

The Experimental Toxicology and Ecotoxicology Unit (UTOX) of the Barcelona Science Park (PCB) conducts preclinical regulatory safety studies under Good Laboratory Practice (GLP) standards. This allows it to pursue programmes to develop new chemicals, biologics, personal hygiene products, medical devices, cosmetics, food additives, chemical products and nanomaterials.

Accordingly, many of these studies may be evaluated by various national and international agencies (AEMPS, EMA, EFSA, SCCS, ECHA, FDA, TÜV, etc.) for test products to be approved for marketing purposes. The success of the UTOX, as a bridge between basic research and registration, lies in the skill and commitment of the team and the degree of quality demanded by regulatory agencies.

Since 2008, the group led by Dr Carme Navarro of the (Research Quality Service (SQR-UB), part of the Agency for Policy and Quality of the University of Barcelona (APQ-UB), has supported the achievement and maintenance of the UTOX’ GLP certification which allowed UTOX offer and provide safety services in the health field through the appropriate Quality Assurance Programme.

In 2018, after a decade of certification and intense collaboration, María José Garcia joined UTOX to enhance the Quality Assurance Unit (QAU). Early 2020, following a training period in the SQR-UB, María José became the leader of the Quality Assurance Unity (QAU-GLP) for UTOX studies, within the Quality, Safety and Environment Department (QSMA) of PCB,.

To overcome challenges of limited mobility and barriers in some areas, Dr Carme Navarro and Dr Rosa María Vilanova, along with María José Garcia and UTOX study director Javier González-Linares, were working towards being able to conduct GLP inspections of critical phases of studies remotely, using videoconferencing applications. This subsequently facilitated continuity of work during the pandemic. Hence, this innovation reinforced the advantages without undermining inspection quality.

“From UTOX would like to share with the entire PCB and UB community our satisfaction and gratitude to the whole team for earning this well-deserved international recognition”, said UTOX director Àngel Menargues.