Please join WIB-Seattle and the Organization of Regulatory and Clinical Associates (ORCA) for a special event at the McMenamins Anderson School in Bothell. We will hear Regulatory Affairs Experts discuss the profession's challenges and successes. Light appetizers and drinks will be served.

Program

5:30 p.m.  Networking
6:00 p.m.  Panel Discussion

Speaker Bios

Ali Bouge, MS, RAC, Executive Director of Regulatory Affairs at Exegenesis Bio

Ali is currently the Executive Director of Regulatory Affairs at Exegenesis Bio, a gene therapy company specializing in ophthalmology and rare genetic diseases. Ali is also a teaching associate professor in the Department of Pharmacy at the University of Washington where she leads the BRAMS practicum program. Ali is a US Regulatory Affairs Certification (RAC) holder, and since graduating from the UW BRAMS program in 2011, Ali has gained extensive experience in the field of biomedical regulatory affairs and clinical trials, particularly with Investigational New Drug (IND) applications and Institutional Review Boards (IRBs) operations. She has worked for IRBs at Stanford University, the University of Michigan, and Quorum Review, and co-directed the Clinical Trials Program at Stanford University within the Department of Pediatrics, Stem Cell and Gene Therapy unit. Her work puts her at the forefront of new developments in regulatory affairs and clinical trials.

Megan Duncan, Senior Manager in Regulatory Affairs at Guardant Health

Megan has over eight years of experience with a focus on IVDs. She has US experience with De Novo, 510(k)s, and IDEs and has also led EU, UK, and Australia submissions. Megan received a Master of Science in Biomedical Regulatory Affairs from the University of Washington and earned her RAC certification in 2019. In her personal life, she likes to spend time cooking and hiking in the San Juan Islands with her husband and dog.

Michael Petrini, VP of Regulatory Affairs – Patient Care Solutions at GE HealthCare 

As part of the senior leadership team, Michael is responsible for global regulatory strategy, policy advocacy, and total product lifecycle for monitoring, anesthesia, respiratory care, maternal infant care, diagnostic cardiology, consumables, service, and digital solutions, including AI. He has demonstrated leadership in regulatory and quality, spanning medical devices, biologics, and pharmaceuticals, and he has had previous roles with Philips and Terumo. He has guided proactive engagements with key competent authorities from the US FDA to NMPA, PMDA, MFDS, and EU Notified Bodies. He is active with university programs to engage with upcoming regulatory professionals to prepare them for an exciting and ever-changing field. Michael holds a BS in neuroscience from Brigham Young University and an MS in bioscience regulatory affairs from Johns Hopkins University.

Michael Willingham, Director of Regulatory Affairs at Google Health

Mike brings 30+ years of experience in the healthcare technology industry, with roles in regulatory affairs, quality assurance, information security, research, product development, human resources, and international business, as well as 20+ years as a senior executive. He has specific experience in healthcare IT, medical device design and manufacturing, embedded and stand-alone software, management system certifications, total quality management, and worldwide regulatory affairs. Mike is also experienced in industry standards development and regulatory agency policy development.

Pricing Information

• Members: $10
• Non-members*: $25

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Please read WIB’s Code of Conduct, In-Person Event Waiver, and Refund Policy.

Note: A confirmation email will be sent after registration has been completed. 

Special Pricing for Guests

Members can register guests at member pricing.

Maximum Capacity

60

Parking Information
Free parking is available at the venue.