Introduction

As the Managing Director of Quality Systems Now, I had the privilege of attending and presenting at the 14th annual PharmOut Pharma & Medical Device Forum, held on March 31 and April 1, 2025, in Melbourne. This forum brought together approximately 250 professionals from the pharmaceutical, medical device, laboratory science, and quality sectors. It served as a dynamic platform for cross-disciplinary engagement, practical knowledge exchange, and collaborative discussion on the future of regulated health industries.

International Representation and Collaboration

One of the defining characteristics of this year’s forum was its strong international representation. Delegates and speakers attended from countries including Australia, the United Kingdom, Italy, France, New Zealand, Pakistan, Singapore, and the United States. The cross-border collaboration illustrated the global nature of pharmaceutical and medical device regulation and the shared challenges in delivering safe, effective, and compliant healthcare solutions. Attendees exchanged knowledge around current global trends, innovative technologies, and the strategic imperatives shaping health systems worldwide.

Plenary Sessions: Setting the Strategic Agenda

The plenary sessions opened the forum with a strategic overview of the life sciences landscape. Professor Greg Hunt’s keynote on global megatrends and their impact on Australian healthcare presented a compelling vision of the future. His discussion spanned developments in genomics, cell therapies, telemedicine, and the growing role of precision health. Government-backed funding initiatives, such as national research investment schemes and commercialisation support, were also addressed, highlighting the importance of public-private partnerships in fostering biomedical innovation.

Other plenary speakers included regulatory experts, manufacturing specialists, and compliance thought leaders. Topics ranged from emerging regulatory frameworks to practical strategies for reducing carbon footprints in pharmaceutical manufacturing. These sessions were valuable for grounding the rest of the forum in a shared understanding of where the industry is headed and how each sector contributes to overall system integrity.

Technical Tracks: Sector-Specific Deep Dives

The technical sessions were organised into several concurrent tracks, each designed to meet the needs of professionals working in specific sectors of the life sciences industry.

Innovation in Pharmaceuticals and Medical Devices

This track explored a wide spectrum of scientific and technological advances driving change in drug development, biotechnology, and device innovation. Topics included mRNA-based therapies, advances in drug delivery systems, and the growing use of AI in diagnostic platforms. Presenters showcased how cutting-edge research is translating into scalable, regulatory-compliant products, with a focus on quality by design, lifecycle management, and global harmonisation of standards.

Regulatory Compliance and Quality Management

With the increasing complexity of global regulations, this track focused on best practices for sustaining compliance in evolving operational environments. Attendees heard from experts on computerised system validation, audit readiness, GMP inspection trends, and the implementation of data integrity frameworks. Real-world case studies demonstrated how companies successfully aligned with regulatory expectations, even in the context of advanced digital manufacturing and decentralised trials.

Sustainable Manufacturing and Contamination Control

A growing area of interest was the integration of sustainability into pharmaceutical and medical device production. Presenters shared strategies for reducing environmental impact while maintaining product quality and safety. Topics included the use of green chemistry, minimising plastic and single-use materials in sterile manufacturing, and cleanroom design principles that promote both efficiency and sustainability. Contamination control remained a priority topic, with discussions on microbial control, personnel behaviour, and facility zoning best practices.

Engineering, Laboratory Science, and Validation

This track catered to process engineers, validation professionals, and laboratory scientists working across product development and commercial manufacturing. Speakers explored evolving facility design trends, process validation strategies for emerging technologies, and analytical methods that support product comparability and stability. The importance of integrating engineering and scientific perspectives to design scalable and compliant operations was a common theme.

Notable Presentations and Insights

Among the many outstanding contributions, several presentations stood out for their depth and relevance. Jofer Princesa’s session on managing product and process specifications throughout the drug lifecycle provided actionable strategies for cross-functional alignment and regulatory consistency. Trevor Schoerie discussed trends in regulatory citations, particularly those related to digital systems and computerised data handling. Matt Schoerie followed with a presentation on digital transformation in quality management systems, offering a roadmap for digitising compliance processes without compromising control.

Siôn Wyn’s discussion on the application of GAMP®5 principles underscored the enduring importance of risk-based approaches to software validation and automation. Anne Saletti-Hayes delivered a forward-looking view of how changes in medical device regulation are influencing product development timelines and post-market surveillance obligations. John Montalto’s insights into the remote healthcare revolution highlighted how wearable devices and decentralised monitoring tools are reshaping clinical engagement and data collection strategies.

Presentation by Quality Systems Now

As part of the Regulatory and Quality track, I had the opportunity to present a session titled “Influencing Top Management for Compliance: How to Talk to Senior Leaders and Get Results.” The presentation focused on the critical role of executive engagement in driving a culture of compliance. I discussed the language, frameworks, and reporting structures that can be used to translate regulatory priorities into strategic business imperatives. The session was well received and reinforced the idea that regulatory professionals must act as change agents and influencers within their organisations.

Key Themes and Takeaways

A number of core themes emerged consistently throughout the forum:

• Digital transformation: The shift towards digital platforms, from data integrity solutions to AI-enabled predictive tools, is gaining traction across all areas of the life sciences.

• Sustainability and responsibility: Manufacturers are increasingly integrating environmentally responsible practices without compromising compliance or product quality.

• Patient-centric innovation: Whether through personalised medicines or smart drug delivery systems, innovation is increasingly focused on delivering tailored solutions for individual patients.

• Global regulatory alignment: Harmonisation of regulatory expectations across regions remains a major challenge but also a priority for multinational companies.

Looking Ahead to 2026

The momentum from this year’s forum sets the stage for continued collaboration and progress. The 2026 forum is already scheduled and expected to bring new topics to the fore, including AI governance, real-time release testing, and the regulatory implications of emerging therapeutic modalities. The ongoing evolution of the regulatory and manufacturing environment means forums like this will only grow in significance.

Conclusion

The PharmOut Forum 2025 delivered a rich, multidimensional experience for all attendees. From strategic plenary sessions to detailed technical workshops, the event highlighted the innovation, rigour, and shared purpose that define the life sciences sector. As a presenter and participant, I found the forum energising and informative. It reinforced the importance of forums where regulators, manufacturers, quality professionals, and innovators can connect and drive the industry forward. I look forward to applying the insights gained and continuing to contribute to the advancement of compliance and innovation within our sector.