San Francisco Bay Area Chapter In Person Event: Shaping the Regulatory Landscape for Body Contouring

Registration Fees & Deadlines

Agenda

5:30 PM - 6:00 PM PST Registration/networking

6 – 7:30 PM PST Presentation (s)

• 6:00 PM – 6:30 PM PST: Carine Hoarau, Director, Product Development - Medical Devices
• 6:30 - 7 PM PST: Vicky Chai, Director, Global Regulatory Affairs & Maria Golovina, Director Global Regulatory Affairs - Body Contouring
• 7 PM – 7:30 PM PST: Fireside Chat/Panel discussion.
  • Participants: Carine Hoarau, Vicky Chai, Maria Golovina, Josie Cabrera (Manager, Business Human Resources)
• 7:30 PM - 8 PM PST Networking/Closing

Speakers

Carine Hoarau
Director, Product Development - Medical Devices, 

Carine Hoarau is Director, Product Development - Medical Devices in Pleasanton, CA. She is responsible for delivering medical devices to the market for the last 25+ years. She has led global teams from proof of concept to commercial launch and lifecycle management. She is a change agent and an innovative leader with over 50 issued patents in electromechanical devices. Carine holds a Bachelor of Sciences in Mechanical Engineering from UC Berkeley.

Vicky Chai
Director of Regulatory Affairs for Body Contouring - Marketed Products

Vicky Chai is Director, Regulatory Affairs Director, Body Contouring and Regulatory Innovation in Pleasanton, CA. She is a seasoned regulatory professional with 20+ years’ experience, including start up and MNCs, leading regulatory activities from cradle to grave of medical devices. Her expertise in US, EU, and China regulatory enables her to strategically incorporate regulatory pathways and deliverables into global development strategies, maximize the value of regulatory science, and expedite market access.

Maria Golovina
Director of Regulatory Affairs for Body Contouring - Marketed Products

Maria Golovina is the Director of Regulatory Affairs for Body Contouring - Marketed Products. With over 12 years of experience in Regulatory Affairs and Quality Assurance within the MedTech industry, Maria has led high-performing teams, managed diverse product portfolios, and established effective product life-cycle systems. Her expertise in process optimization and problem-solving has enabled her to deliver practical solutions to key stakeholders. Maria has also driven growth initiatives for both start-ups and global companies, helping start-ups meet venture capital milestones and guiding global companies to gain competitive advantages in the U.S. Her achievements demonstrate her ability to align regulatory strategies with business objectives.

Josie Cabrera
Manager, Business HR, Allergan Aesthetics R&D

I am the Manager, Business HR, Allergan Aesthetics R&D. I love connecting with people, staying curious, and continually learning. Being part of a team is something I genuinely value, as I believe in the interconnectedness of all of us and the power of collective effort. Together, we can achieve far more than we ever could individually. I find joy in cheering and supporting others, knowing that there is enough sunshine for everyone.

With more than 14 years of HR experience supporting diverse global business groups, including R&D, Operations, Sales, and Marketing. I hold dual BAs in Psychology and Sociology from California State University Fullerton. Accredited in Human Resources Management and Dispute Resolution. My expertise has contributed to the semiconductor industry, not-for-profit organizations, and educational institutions.

Moderator

David Pudwill (Moderator)
Principal Consultant, Mr. Regulatory

David Pudwill is a seasoned leader and regulatory expert who helps companies get medical devices and combination products to market. David has served in senior leadership roles at AscentX Medical and ConvaTec, and previously worked at the U.S. Food and Drug Administration (FDA), and St. Jude Medical. He is a founding member of the Kidney Health Initiative, and has helped several startups acquire funding and successfully interact with FDA and the Department of Defense. While at FDA, David worked on DARPA projects and consulted with CBER and CDER regarding regulatory submissions, including clinical studies and drug and biologic marketing submissions. 

David holds a Master of Mechanical Engineering from Johns Hopkins University, a BSE in Biomedical Engineering from Case Western Reserve University, and a Certificate from HBX, now Harvard Business School Online.

Location

Allergan Aesthetics, an AbbVie Company
4410 Rosewood Dr
Pleasanton, CA 94588

Sponsors

Allergan Aesthetics an AbbVie company
Providing food and drinks 

Coolsculpting Allergan Aesthetics
Providing food and drinks 

Platinum Chapter Sponsors 

MDSS 

RxTROSPECT

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions