B07.Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
Tracks
Pharmacovigilance
Wednesday, June 4, 2025 |
11:15 AM - 12:15 PM |
C2.5+C2.6 |
Chair & Speakers
Andre Raymundo
Patient Safety Manager
Commercial Eyes
Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
Abstract
Australia has emerged as a strategic gateway for pharmacovigilance leadership in the Asia-Pacific (APAC) region, leveraging its robust regulatory framework, advanced healthcare infrastructure, and strong focus on patient safety. This abstract explores Australia's role as a regional hub for pharmacovigilance, highlighting the Therapeutic Goods Administration's (TGA) progressive policies, its alignment with international standards, and its commitment to fostering global collaborations. Furthermore, Australia’s position as a trusted partner is reinforced by its capacity for generating high-quality real-world evidence, driven by extensive healthcare data systems and a well-integrated network of research institutions. The abstract also examines the potential challenges, such as regulatory harmonization across APAC and cultural diversity in patient safety reporting, while identifying opportunities for Australia to spearhead innovation and capacity building in pharmacovigilance. By solidifying its leadership role, Australia is poised to enhance drug safety monitoring and contribute significantly to the health outcomes of the APAC region.
Biography
Andre Raymundo is a Senior Patient Safety Manager at Commercial Eyes. With over 10 years of experience in PV, Andre has developed a strong foundation in patient safety and risk management through various roles across the consultancy, CRO, and pharmaceutical industry settings.
At Commercial Eyes, Andre functions as QPPV on behalf of several Australian sponsors, ensuring compliance to pharmacovigilance requirements to the TGA. Building on this expertise, he also plays a key role in expanding Commercial Eyes’ presence across the JAPAC region, including strengthening PV capabilities in the Philippines, Japan, and Korea. He is responsible for maintaining and growing CE’s pharmacovigilance system offerings, ensuring alignment with local, regional, and global requirements.
Andre holds a Bachelor of Science degree in Nursing and has completed educational units towards a Master of Science in Health Informatics. Outside of work, André enjoys baking, particularly traditional Filipino desserts, and has recently developed a passion for making espressos, often spending his early mornings and weekends brewing coffee.
Sue Low
Global Medical Affairs Director, URT & AMENA
iNova Pharmaceuticals
Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
Abstract
Australia has emerged as a strategic gateway for pharmacovigilance leadership in the Asia-Pacific (APAC) region, leveraging its robust regulatory framework, advanced healthcare infrastructure, and strong focus on patient safety. This abstract explores Australia's role as a regional hub for pharmacovigilance, highlighting the Therapeutic Goods Administration's (TGA) progressive policies, its alignment with international standards, and its commitment to fostering global collaborations. Furthermore, Australia’s position as a trusted partner is reinforced by its capacity for generating high-quality real-world evidence, driven by extensive healthcare data systems and a well-integrated network of research institutions. The abstract also examines the potential challenges, such as regulatory harmonization across APAC and cultural diversity in patient safety reporting, while identifying opportunities for Australia to spearhead innovation and capacity building in pharmacovigilance. By solidifying its leadership role, Australia is poised to enhance drug safety monitoring and contribute significantly to the health outcomes of the APAC region.
Biography
Based in Sydney, Australia, Sue Low is a pharmacist by training and currently holds the role of Global Medical Affairs Lead at iNova Pharmaceuticals, a leading independent consumer health company with exciting growth and strong innovation with products available in 75 markets and counting. iNova’s global head office is based in Singapore, with offices in 14 markets across Asia Pacific, Africa, Middle East, Europe and Canada.
An industry leader, Sue has extensive experience leading patient safety and medical affairs functions through multiple product acquisitions, integrations and rapid market entries across a number of multi-national companies.
During her career, Sue has built a reputation for establishing compliant, scalable pharmacovigilance-medical frameworks quickly and efficiently, ensuring clear governance, global–local alignment and operational excellence that also bridges medical, patient, regulatory and commercial priorities to protect patients while also enabling business agility.
Sue's philosophy is that pharmacovigilance must extend beyond the narrow lens of compliance — fundamentally, it is about building trust, establishing meaningful partnerships, and enabling safe, sustainable growth in a fast-moving healthcare environment.
Kristina Pearce
Senior Director, Clinical Safety and Pharmacovigilance - APAC, Clinical Safety and Pharmacovigilance
Moderna
Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
Abstract
Australia has emerged as a strategic gateway for pharmacovigilance leadership in the Asia-Pacific (APAC) region, leveraging its robust regulatory framework, advanced healthcare infrastructure, and strong focus on patient safety. This abstract explores Australia's role as a regional hub for pharmacovigilance, highlighting the Therapeutic Goods Administration's (TGA) progressive policies, its alignment with international standards, and its commitment to fostering global collaborations. Furthermore, Australia’s position as a trusted partner is reinforced by its capacity for generating high-quality real-world evidence, driven by extensive healthcare data systems and a well-integrated network of research institutions. The abstract also examines the potential challenges, such as regulatory harmonization across APAC and cultural diversity in patient safety reporting, while identifying opportunities for Australia to spearhead innovation and capacity building in pharmacovigilance. By solidifying its leadership role, Australia is poised to enhance drug safety monitoring and contribute significantly to the health outcomes of the APAC region.
Biography
Kristina brings nearly 20 years of experience working in the Pharmaceutical Industry in a variety of roles and is currently holding the position of Senior Director, Clinical Safety and Pharmacovigilance (PV), APAC Region for Moderna. At Moderna, Kristina is responsible for leading and building a PV and Safety Operation that supports Moderna's mission of bringing transformative mRNA therapies to patients and its commitment to patient safety in the APAC region. Prior to commencing her role at Moderna, Kristina worked for over 7 years at Alexion Pharmaceuticals Australasia as the Director, Regional Safety Excellence, Australasia, and Head of Regional Standards team. Prior to joining Alexion Pharmaceuticals in 2014, she held several Global based Pharmacovigilance roles at Merck Serono's Geneva Headquarters. Kristina holds a Bachelor of Pharmacy (Hons) and an MBA from the University of Geneva. Kristina loves to run, is currently training for a half-marathon, enjoys working and travelling through Asia and has a passion for Asian street-food.
Ms. Christina Lake
PV & MI Consultant
Etikos Consulting
Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
Abstract
Australia has emerged as a strategic gateway for pharmacovigilance leadership in the Asia-Pacific (APAC) region, leveraging its robust regulatory framework, advanced healthcare infrastructure, and strong focus on patient safety. This abstract explores Australia's role as a regional hub for pharmacovigilance, highlighting the Therapeutic Goods Administration's (TGA) progressive policies, its alignment with international standards, and its commitment to fostering global collaborations. Furthermore, Australia’s position as a trusted partner is reinforced by its capacity for generating high-quality real-world evidence, driven by extensive healthcare data systems and a well-integrated network of research institutions. The abstract also examines the potential challenges, such as regulatory harmonization across APAC and cultural diversity in patient safety reporting, while identifying opportunities for Australia to spearhead innovation and capacity building in pharmacovigilance. By solidifying its leadership role, Australia is poised to enhance drug safety monitoring and contribute significantly to the health outcomes of the APAC region.
Biography
Based in Brisbane, Australia, Christina Lake is the founder of Etikos Consulting, a consultancy that partners with clients for right-sized, sustainable, scalable and audit-ready Pharmacovigilance and Medical Information solutions.
After more than 24 years in biopharma operations and leadership, what continues to drive Christina is the pursuit of excellence for improved patient outcomes. As a strong believer in balancing technical knowledge and compliance requirements with operational agility, Christina blends strong functional expertise with a pragmatic, customer and patient centric approach.
A sizeable part of Christina’s career has involved remote and multi-cultural team leadership across the Asia Pacific region, while based in Australia. Christina has had pivotal roles in leading and transforming regional operations and teams, including at Kyowa Kirin and UCB Pharma. This included improving cross-country and cross-functional integration and collaborations, strengthening governance frameworks and harmonising operations across Australia, China, Japan, ASEAN, India, Korea and Taiwan.
Christina has championed Pharmacovigilance and Information at various cross-functional initiatives, including in mergers, acquisitions and divestments, bridging technical expertise and compliance requirements with corporate growth and organisational change.
Outside of work, Christina is an Adjunct Lecturer at the School of Pharmacy, University of Queensland, helping grow the next generation of healthcare professionals.
