The ARCS PV summit brought together pharmacovigilance (PV) professionals, qualified persons for pharmacovigilance (QPPVs), and industry experts to discuss key topics, best practice, challenges, and strategies for promoting inspection readiness. The summit was a collaborative learning environment, providing valuable insights into common audit and inspection findings, discussion about the legal framework of Australian regulations related to inspection findings, and useful strategies to adopt to be inspection ready.
The morning session, The QPPV forum, promoted group brainstorming and discussion of QPPV responsibilities, highlighting successes and areas for improvement within the regulatory framework.
Sessions one and two, The Therapeutic Goods Administration (TGA) Pharmacovigilance Inspection Program (PVIP) reforms and Common Inspection Deficiencies updates, may have been the most keenly anticipated sessions among attendees.
In these two sessions, the TGA provided updates relating to common inspection findings, areas for improvement, and reaffirmed the continued support of the industry through the provision of education via open forums, such as the ARCS conferences.
Some of the key takeaways from the two TGA sessions were:
- The TGA is there to support and answer sponsor questions, including during inspections, to increase understanding and to ensure compliance
- A key focus for the TGA is to provide more education via peak-body events. Targeted education related to specific areas of need will be rolled out. For example, this year the TGA will deliver education specific to sponsors of listed medicines.
- The TGA is focused on increasing the number of inspections per year
- The TGA is revising inspection timeframes, providing more focused document requests, and leveraging AI technologies to create internal efficiencies related to inspection documentation.
- The TGA is open to feedback from sponsors regarding the limiting of topic areas during an inspection, unless significant issues are found with those topics within scope
- The top three deficiencies seen in inspections relate to collection/collation of adverse reactions, quality management systems, and the management of reference safety information
- The agency noted it will publish a bi-annual PVIP report in a more concise format
- Sponsors are encouraged to provide inspection feedback to the TGA to identify areas for improvement
By applying the valuable insights, best practices, and strategies learned during the ARCS summit, companies can strive to enhance their own PV professional development, strengthen PV systems, and promote an inspection-ready culture within their organizations.
