Carl Bufe, Director of Pharmacovigilance for the Asia Pacific region at PharmOut, brings over 23 years of expertise in pharmacovigilance, regulatory affairs, and pharmacy. He has honed his patient safety, leadership, systems architecture, and project management skills with degrees and training in Pharmacy, Commerce Risk Management, Quality Systems, Regulatory Affairs and Artificial Intelligence. A recognised leader and speaker, he has significantly advanced drug safety and medicine management, ensuring strict compliance with regulatory standards. Passionate about AI's potential in healthcare, Carl is committed to ethically integrating AI to improve patient outcomes and optimise services.

Michelle Lott is founder and principal of leanRAQA. She's supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). She serves as mentor in residence for several medical device incubators and guest lectures on regulatory affairs. She holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University. Nic is a medical technology consultant in health economics, payer perspective, reimbursement and market access. After finishing school in Boston, he began his career as a payer determining which medical technologies were paid for by Intermountain Healthcare. He started and eventually took public a biotech company . He is presently in health economics and market access at a major medical device manufacturer. Nic consults venture capitalists and start-ups who are working on new life science products, helping them identify what health insurance companies and hospitals want in a technology and for what they’re willing to pay. He is a strategic advisor to medical technology companies and is a guest lecturer at UCSF School of Medicine

A regulatory affairs professional at PharmOut, with a broad range of experience in medical devices (including software), in vitro devices (IVDs), and complementary medicines. Knowledgeable in regulatory activities such as pre-market processes including marketing authorisation submissions and post-market processes such as regulatory file maintenance, recalls and complaints within Australia, New Zealand and the United States. Throughout her career she has gained expertise in applying the principles and requirements of ISO 13485 (Medical Devices), ISO 14971 (Risk) and IEC 62304 (Software).