Conference insights by Andre Raymundo MMPP, Sue Low, Kristina Pearce MMPP and Christina Lake MMPP

Australia is well placed to take on a greater leadership role in pharmacovigilance (PV) across the Asia-Pacific (APAC) region, according to a panel of experienced PV professionals at the ARCS Annual Conference. The discussion explored how Australia's strengths in regulation, infrastructure, and workforce maturity make it a strategic hub for regional PV collaboration.

Chairing the session, Andre Raymundo opened with a clear case: Australia has a strong regulatory foundation through the TGA, robust academic and training capacity, and geographic and diplomatic advantages in the APAC region. With experience across the region and in-country insight, Raymundo highlighted Australia’s potential as a “gateway” for PV leadership and regional capability building.

Christina Lake, with more than two decades of multicultural leadership experience, focused on the rich diversity of APAC and its implications for PV. She described the region as one of the most socially and culturally diverse in the world, encompassing 60 percent of the global population and over 3000 languages. This diversity has a significant impact on pharmacogenomics, patient trust in healthcare systems, and the way adverse events are reported. Lake stressed that understanding the region's cultural and economic differences is essential for building effective PV systems.

“Pharmacovigilance is ultimately about people,” Lake said. “We need to understand their environment, beliefs, and behaviour to make patient safety systems truly work.”

Lake also reflected on her leadership experiences, noting the importance of cultural sensitivity and community building within teams. She advocated for “weaving the community” by recognising cultural celebrations and fostering inclusion across dispersed teams. Effective PV leadership, she said, is not only about regulatory knowledge but also about building trust, influencing across cultures, and strengthening team capabilities.

Sue Low, Global Medical Affairs Director at iNova Pharmaceuticals, followed with a practical focus on cross-functional collaboration. Drawing on her experience working across 45 markets, Low identified challenges such as inconsistent regulatory expectations, varying levels of PV maturity, and language and communication barriers. These factors, she argued, make cross-border collaboration in APAC particularly complex.

Low proposed several enablers of regional alignment: harmonised SOPs clustered by PV maturity, cross-functional training programs, digital dashboards for KPI tracking, and regular feedback loops. She shared a structured framework her team has used to enhance alignment between global PV, affiliates, and regional partners, positioning Australia as a knowledge centre and coordination point.

“Australia brings credibility,” Low said. “It’s mature regulatory environment and experience in PV operations make it the glue in a complex regional system.”

Kristina Pearce from Moderna expanded on Australia’s regulatory leadership, pointing to the country’s active pharmacovigilance inspection program and the alignment of Australian Regulations with global PV norms. She underlined that Australia's structured and detailed requirements lead to the development of deep and extensive PV expertise that may be leveraged to support other APAC based affiliates facing more ambiguous or evolving local guidelines.

Pearce provided a case study on managing clinical trial safety issues across Australia and Japan. The Australian team’s strong grounding in local safety notification requirements allowed them to influence and align global processes to meet both Australian and Japanese expectations more effectively, demonstrating how Australian-led PV teams can support and harmonise processes across borders.

The panel concluded with a Q&A session, where attendees asked about cost considerations and the potential role of artificial intelligence in PV in general. The consensus was that while salary costs in Australia may be comparable to Singapore or Hong Kong, the value of experienced Australian PV leaders lies in their ability to interpret complex regulations, train regional teams, and act as a bridge between affiliates and global headquarters. On AI, panellists noted its potential for operational efficiency but stressed the continued need for human oversight, particularly when interpretation, nuance, and context are involved.

Australia’s PV professionals, with their strong quality management systems, strategic location, and deep regulatory understanding, are well positioned to lead regional initiatives that elevate pharmacovigilance standards across APAC. As regulatory frameworks continue to evolve, Australia can play a vital role in shaping a harmonised, collaborative future for medicine safety in the region.