The Regulatory Roadmap for Medical Devices

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10/11/2016 12:00 10/11/2016 14:30 America/Toronto The Regulatory Roadmap for Medical Devices IBM Canada Offices , 3600 Steeles Avenue East , Markham , ON L3R 9Z7 JLABS @ Toronto false DD/MM/YYYY

The Regulatory Roadmap for Medical Devices

IBM Canada Offices , 3600 Steeles Avenue East , Markham , ON L3R 9Z7

November 10, 2016 from 12:00 PM to 14:30 PM (EST)

$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 and Health Canada submissions?

Learn about FDA and Health Canada regulatory requirements, specifically FDA processes (Section 510(k) clearances, Premarket Approval (PMA), and Combination Products) and Health Canada's medical device licensing requirements. 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.

Don't miss the opportunity to apply for a one-on-one meeting with our experts to further discuss your company and your personal path to regulatory success.

11:00 AM | Registration Opens
11:30 AM | Presentations
12:30 PM | Q&A
1:00 PM | Lunch and Networking
1:30-5:00 PM | 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 November 4th, 2016.

Young Kim | Director of Regulatory Affairs, Johnson & Johnson Medical Companies read bio»
Sharon Starowicz | Director, Regulatory Policy Innovation, Global Orthopaedics, Johnson & Johnson read bio»

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Presentation & Lunch
CA$ 40  | General Public
CA$ 25  | Student/Academic
CA$ 50  | 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 Nov 9, 2016 (or sold out).

One-on-One Meeting
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 November 4th, 2016. Your application will be reviewed and you will be notified of acceptance by email on November 7th, 2016. Acceptance of a one-on-one meeting is not guaranteed as all applications must be approved.

IBM Canada Offices
3600 Steeles Avenue East, Room D109
Markham, Ontario

Speakers' Biographies:

Young Kim | Director of Regulatory Affairs, Johnson & Johnson Medical Companies
Young Kim is the Director of Regulatory Affairs at Johnson & Johnson Medical Companies in Markham, Ontario. Johnson & Johnson Medical Companies operates as an umbrella organization that markets and distributes products from a number of different medical device companies. Products marketed include medical devices for minimally invasive and open surgical procedures, devices for women's health, cardiovascular and neurovascular products, breast implants, hemostasis devices, orthopaedics implants and instrumentation, and sterilization products. Young is responsible for providing strategic regulatory guidance to a team of regulatory professionals responsible for ensuring appropriate regulatory authorizations required for distribution of products in Canada. She also works to shape the Canadian regulatory environment as a member of the Regulatory Affairs Steering Committee of MEDEC, Canada's Medical Device industry association and is a co-chair of the MEDEC Pre-submission team focusing on regulatory issues related to pre-market authorizations of medical devices in Canada. Young also is a member of the Regulatory Affairs Professionals Society (RAPS) exam committee focusing on the Canadian Regulatory Professional Certification Exam.
Young received an honors BSc. in Science and Business from the University of Waterloo and obtained the Regulatory Affairs Certification through RAPS. Throughout her career, Young has accumulated over 20 years of regulatory experience with generic pharmaceuticals, disinfectant drugs, medical devices, combination products, procedural kits and investigational devices.

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).

JLABS @ Toronto

About Johnson & Johnson Innovation, JLABS Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and healthtech sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to ten global locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto, Beerse (Belgium), with New York City, opening in June 2018, and Shanghai in 2019. For more information please visit or follow @JLABS. About Johnson & Johnson Innovation Johnson & Johnson Innovation focuses on accelerating all stages of innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson's global healthcare businesses. Johnson & Johnson Innovation provides scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical device and consumer companies of Johnson & Johnson. Under the Johnson & Johnson Innovation umbrella of businesses, we connect with innovators through our regional Innovation Centers, Johnson & Johnson Innovation | JLABS, Johnson & Johnson Innovation - JJDC, and our Business Development teams to create customized deals and novel collaborations that speed development of innovations to solve unmet needs in patients. For more information please visit or follow @JNJInnovation.

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