Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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In Person Meeting- Regulatory Affairs Panel: Career Pathways and Industry Trends
TOPIC: Regulatory Affairs Panel: Career Pathways and Industry Trends, an In-person Networking Event
TOPIC DESCRIPTION:
Please join ORCA and Women in Bio on August 14th from 5:30pm to 8:30pm for a special Regulatory Affairs Panel. Hear from industry experts on the latest trends in regulatory affairs and learn how they developed their careers.
The event will be held at the McMenamins Anderson School in Bothell. Small bites, including vegetarian options, will be provided, and each attendee will receive two drink tickets for alcoholic or non-alcoholic beverages. Come early for a fun networking game and win prizes. Stay late for deeper discussions and more networking!
Read on below for information on four of our featured panelists!
PANELISTS:
Mike Willingham Director, Reg Affairs, Google Health + Affiliate Assistant Professor, Dept. Pharmacy, UW
Megan Duncan Senior Manager in Regulatory Affairs, Guardant Health
Michael F. Petrini Executive, Regulatory Affairs - Patient Care Solutions, GE HealthCare
Ali Bouge Executive Director, Reg Affairs, Exegenesis Bio + Associate Teaching
Professor, School of Pharmacy & Practicum Director, BRAMS, UW
Learn More about our Panelists:
Mike Willingham
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.
Megan Duncan
Megan is a Senior Manager in Regulatory Affairs at Guardant Health in Palo Alto, California. She has over 8 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 F. Petrini
Michael is the VP of Regulatory Affairs at GE HealthCare over the Patient Care Solutions businesses. 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, including 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 Neuroscience from Brigham Young University and an MS in Bioscience Regulatory Affairs from Johns Hopkins University.
Ali Bouge
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.
This event is open to the public-
$10 for ORCA and WIB members and guests, limit one guest per member
$25 for non-members
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied towards re-certification /continuing education from the following organizations:
| 1.5 pts |
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RAC recertification from RAPS |
| 1.5CEUs |
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CCRP recertification from SOCRA |
| 1.5CEUs |
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CIP recertification from PRIM&R |
All attendees must be registered. Access to education content is a benefit of membership or guest attendance. Any access/distribution of materials beyond the individual registrant is strictly prohibited. This event may be recorded. Viewing rights are not transferable and cannot be combined by multiple parties without express permission. Thank you for your understanding.
Registration is required before Tuesday, August 13, 2024 at 6:00 PM
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