Navigating the Regulatory and Quality (MDSAP) Pathways of Medical Devices by implementing Health Canada’s New Requirements Workshop
March 7, 2019
9:00 a.m – 5:00 p.m.
CAD $585.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Dr. Valentin Fulga
A graduate of the Ben Gurion medical school in Beer Sheva, Israel, Dr. Fulga is a serial entrepreneur in the life science industry. He has over 20-year experience in the development of medical products, regulatory submissions and clinical trials in various jurisdictions including, Canada, the US and the EU. Recently he has participated in an international forum discussing the future of medical products and assessing the preparedness of the regulatory authorities and companies towards licensing and marketing of technologically advanced products. Dr. Fulga has been a speaker at numerous medical, scientific and business international meetings. A few years ago he established along with two partners, NetValue BioConsulting Inc., a Canadian regulatory consulting firm that utilizes the diverse experience and expertise of its partners, to help other companies achieve their goals.
Ms. Netta Fulga
Ms. Fulga has an MSc. in biochemistry from the Hebrew University in Jerusalem. She is also a Certified Quality Auditor by the American Society of Quality (ASQ). Ms. Fulga has over 25 years experience in bio-pharmaceutical research and development, and bio-medical laboratory management in Israel and in Canada. She managed various projects of medical product development and prepared many documents for regulatory submissions. She established and managed quality systems and was a quality manager in a medical laboratory of one of the largest hospitals in Canada, where she prepared for and achieved regulatory approvals from the authorities. Ms. Fulga is a managing partner of NetValue BioConsulting Inc., a Canadian regulatory consulting firm that utilizes the diverse experience and expertise of its partners, to help other companies achieve their goals.
About the course:
Medical devices companies who develop their products and wish to sell them in the Canadian market, must acquire knowledge of the Canadian regulatory requirements for medical devices. Moreover, in order to be able to commercialize their products, the manufacturer/importer/distributer must be aware of the new regulatory framework that Health Canada has developed for these products.
Harmonization of the regulatory requirements between Health Canada, the FDA and other regulatory bodies, including the new Medical Device Single Audit Program (MDSAP), is continuously evolving and is intended to reduce the regulatory burden on both the manufacturers and the regulators.
The course will outline the main Canadian regulatory requirements for:
- ITA submission
- Licensing application
- Establishment of Quality Management Systems
- Risk management
During the course we will also discuss:
- The differences and the similarities between medical devices regulations in Canada, the US and the EU
- Canadian regulatory requirements for medical devices as per the new QMS standard ISO 13485:2016
- The transition to MDSAP
- The transition to electronic submission of documentation
Syllabus of the course:
- The Structure of Health Canada
- The definition of medical devices according to Health Canada
- Classification of medical devices
- Canadian regulations of medical devices
- Comparison of regulatory requirements in Canadian and other jurisdictions (US, EU)
- Mutual recognition of data between various regulatory authorities
- Preparation and submission of Pre-ITA, ITA, Licensing application
- Quality systems according to ISO 13485:2016
- Risk management according to ISO 14791
- Clinical trials
- Types of clinical trials for medical devices
- Clinical trial regulatory requirements
- How clinical trials impact the future commercialization of a medical device
- Record keeping
- Vigilance program
- Preparation for audits in compliance with Health Canada requirements
- New Canadian regulatory requirements
- Transition to ISO 13485:2016
- Transition to MDSAP
- Transition to e-submission – Non-eCTD Format
Who should attend?
Personnel involved with:
- Regulatory affairs
- Quality assurance
- Product development
- Clinical development
Benefits to the participants:
Gain knowledge about:
- Canadian regulatory requirements for approval of medical devices including products approved in other jurisdictions
- Preparation for and compliance with the new Canadian regulatory requirements for medical devices
- Risk management and quality systems requirements
- Regulatory requirements for clinical trials of medical devices
Certificate of Attendance and Course Material
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking (Please indicate any special Dietary requirements when registering for the course)
Note: Registration closes one week prior to the start of workshop.