The Regulatory Roadmap for Medical Devices
Microsoft , 4th Floor Multi-purpose rooms , Cambridge , MA
April 07, 2016 from 13:00 PM to 15:00 PM (EDT)
$10 - $35
Regulatory and compliance requirements for medical devices can sometimes feel like a moving target. The regulatory function in the healthcare industry is critical in order to make safe and effective products available worldwide. What can you do to stay ahead of the curve when it comes to FDA submissions and protocols?
Learn about FDA Section 510(k) clearances, the Premarket Approval (PMA) and Biologics License Applications (BLA) processes. This session will help you pinpoint the information you need to develop a regulatory strategy, and then hit the ground running. Learn the next steps you need to take to bring your device to market.
Sharon Starowicz from Johnson & Johnson's Orthopedics business and Raina Dauria from Ethicon BioSurgery have a combined 50 of years of experience in the medical device regulatory field.
Don't miss the opportunity to apply for a 1-on-1 meeting with Raina as a forum to further discuss your company and your personal path to regulatory success.
11:00am | Registration Opens, Lunch, and Networking
11:30am | Presentations
12:30pm | Q&A
1:30-5:00pm | One-on-one Meetings*
*Companies must have applied for a one-on-one meeting ahead of time and been approved. The application period ends on March 17th, 2016.
Raina Dauria | Senior Director, Regulatory Affairs, Ethicon BioSurgery, Johnson & Johnson read bio»
Sharon Starowicz | Director, Regulatory Policy Innovation, Global Orthopaedics, Johnson & Johnson read bio»
Presentation & Lunch
$35 | General Public
$20 | Student/Academic
$45 | At the door
Includes presentation, Q&A, and lunch. All attendees must pay this fee, regardless of one-on-one meeting status. Registration to attend the presentation, Q&A, and lunch will remain open until noon on April 6, 2016 (or sold out).
FREE | Application
FREE | Accepted Companies
Companies must have applied for a one-on-one meeting ahead of time. The one-on-one application period ends on March 17th, 2016. Your application will be reviewed and you will be notified of acceptance by email on March 28th, 2016. Acceptance of a one-on-one meeting is not guaranteed as all applications must be approved.
4th Floor Multi-purpose rooms
255 Main Street
Raina Dauria | Senior Director, Regulatory Affairs, Ethicon BioSurgery, Johnson & Johnson
Raina Dauria is Senior Director of Regulatory Affairs for Ethicon Biosurgery, a platform within Ethicon, Inc. Raina leads a global organization of regulatory professionals dedicated to supporting the delivery of innovative, forward thinking regulatory strategies for medical devices, biologics and combination products, to ultimately benefit patients worldwide. She has overall responsibility for strategic regulatory activities of marketed products across all Ethicon Biosurgery platforms: Biologics, Devices, Biologics/Device combination products, Polymer, Synthetics, Bioseal (China) and Biopatch.
Prior to joining Ethicon in 2011, Raina worked for Advanced Technologies and Regenerative Therapeutics, LLC., part of the Johnson & Johnson Family of Companies, with experiences spanning from pre-approval regulatory submissions for device, biological and combination products, oversight of Clinical Research, Field Scientific Affairs and Quality Assurance.
Raina received her Bachelor of Science in Biology from Fairfield University, Fairfield, CT and her Master of Science in Drug Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy, Boston, MA. Raina has also obtained her Regulatory Affairs Certification, issued by the Regulatory Affairs Professionals' Society. She has been a member of the RAPS Board of Directors since January 2015.
Connect with Raina:
Sharon Starowicz | Director, Regulatory Policy Innovation, Global Orthopaedics, Johnson & Johnson
Sharon Starowicz is the Director of Regulatory Policy Innovation, Global Orthopaedics, for Johnson & Johnson, where she is responsible for providing strategic regulatory guidance and expertise and, with a focus on the external environment, shaping the evolving regulatory policies that impact our industry.
Sharon has over 30 years of regulatory affairs experience, specializing in Class I, II and III orthopedic and spinal devices. She began her regulatory career at the US Food and Drug Administration as a Biomedical Engineer/ Scientific Reviewer, where she reviewed engineering and clinical data submitted in support of orthopedic device approvals (510(k)s, IDEs and PMAs). She has worked for Johnson and Johnson for 19 years in 3 operating companies, having previously been a member of the Indigo Medical, Inc. management board with responsibilities for regulatory affairs, clinical affairs and quality systems, and having regulatory affairs and regulatory compliance responsibilities for DePuy Orthopaedics, Inc. prior to joining DePuy Spine, Inc. in 2004.
Sharon currently serves as the President of the Orthopedic Surgical Manufacturers Association (OSMA), an industry trade organization whose membership consists of manufacturers of orthobiologics, orthopedic and spinal devices, who work with FDA and other regulatory agencies and health care professionals on issues that lessen the regulatory burden and improve the application of device law. Sharon is also a member of the Medical Device Innovation Consortium (MDIC) Computer Modeling and Simulation Steering Committee, as well as a member of the American Academy of Orthopaedic Surgeons (AAOS) Orthopaedic Device Forum.
Sharon holds a BS degree in Engineering Science and Mechanics and an MS degree in Engineering Mechanics from Virginia Polytechnic Institute and State University (Virginia Tech).