[London, ON] The Regulatory Roadmap for Medical Devices
Event Date: Thu, 2017-05-18 10:00 to 13:00
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 Health Canada submissions?
Learn about Health Canada regulatory requirements and Health Canada’s medical device licensing requirements from Young Kim, Director of Regulatory Affairs, Johnson & Johnson Medical Companies. 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.
In addition, Breanne Halyk, Innovation Activation Specialist, JLABS @ Toronto, Johnson & Johnson Innovation, will also provide overview of J&J Innovation goals and mission, highlighting how J&J Innovation interacts with the entrepreneurial community through JLABS, JJDC, and other J&J Innovation initiatives.
How can Johnson & Johnson Innovation help you reach your goals? Johnson & Johnson Innovation (JJI) is supporting innovation in major life science clusters through the life science incubator, Johnson & Johnson Innovation, JLABS (JLABS), with the ultimate aim of enabling commercialization of new healthcare solutions for patients. We know what you, the innovator, need to get your science to patients. It is because of you that JJI created regional centers that host a team of science and transaction experts whose goal is to find high potential early-stage (pre-clinical proof-of-concept) innovation and form custom business solutions around it to help accelerate the science to the patient.
Johnson & Johnson Innovation areas of interest in Medical Devices include:
- 3-D Printing
- Bariatric / Metabolic Surgery
- Ear, Nose and Throat
- General & Minimally Invasive Surgery
- Infection Care
- Surgical Oncology
- Vision Care
10:00 AM | Registration Opens
10:30 AM | Presentations
11:30 PM | Q&A
12:00 PM | Lunch and Networking
1:00-3:00 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 April 25th, 2017.
Young Kim | Director of Regulatory Affairs, Johnson & Johnson Medical Companies read bio»
Breanne Halyk | Innovation Activation Specialist, JLABS @ Toronto, Johnson & Johnson Innovation read bio»
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 May 17, 2017 (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 April 25th, 2017. Your application will be reviewed and you will be notified of acceptance by email. Acceptance of a one-on-one meeting is not guaranteed as all applications must be approved.
Fisher Conference Room, Robarts Research Institute
Schulich School of Medicine & Dentistry, Western University
1151 Richmond St
London, ON N6A 5B7
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.
Breanne Halyk | Innovation Activation Specialist, JLABS @ Toronto, Johnson & Johnson Innovation
Breanne is the Innovation Activation Specialist at JLABS @ Toronto. Breanne supports overall brand building and engagement for J&J Innovation & JLABS throughout Canada, as well as market and drive awareness of the JLABS value proposition for prospective companies through activation initiatives. Additionally, she is responsible for supporting external engagements in order to advance business objectives. Her role includes coordinating high-quality, diverse and distinctive programming ranging from one-on-one investor meetings, workshops and large panel series to networking, social events and Grand Openings.
Prior to joining JLABS @ Toronto, Breanne worked for The Princess Margaret Cancer Foundation in Toronto as the Marketing & Events Associate, Business Development & Strategic Initiatives. In her role with Princess Margaret, Breanne worked on a number of their key fundraising events including OneWalk to Conquer Cancer, The Enbridge Ride to Conquer Cancer and Road Hockey to Conquer Cancer, where she was responsible for the planning and execution of numerous high-profile events, internal communications & marketing activities. Breanne holds an Honours Business Degree from the Richard Ivey School of Business at Western University.