2016 MEDEC Regulatory Conference MAY 9 11, 2016 Transformation through Collaboration
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1 Monday, May 9, :30 pm Registration and Coffee 2:30 2:45 pm Welcome to Linda Lindsay, Chair, MEDEC Regulatory Affairs Committee Brief welcome as the official Opening Remarks will take place on Tuesday, May 10. 2:45 3:15 pm Certification and Compliance Requirements for Medical Device Radio Apparatus 3:15 5:00 pm Reprocessing of SUDs & Sterilization of Medical Devices Carey Agnew, Associate Director, MDB, Health Canada Hughes Nappert, Manager, Regulatory Standards, Innovation Science & Economic Development Canada Nicolas Desmarais, Manager, Certification & Market Surveillance, Innovation Science & Economic Development Canada Karen Kennedy, Scientific Evaluator, Cardiovascular Devices, MDB, Rod Parker, Sr. Principle Scientist, Stryker Overview of the role that Industry Canada plays in ensuring compliance of radio apparatus. The session will cover the certification process and general requirements for compliance. s requirements around licensing of reprocessed SUDs. General overview of the process around validation methods used during product development of sterile medical devices
2 Tuesday, May 10, :30 am Registration and Breakfast 8:30 8:45 am Welcome to Kimby Barton, Director, Marketed Pharmaceutical and MDB, 8:45 10:15 am What s New at Sarah Chandler, A/Manager, Device Licensing & Services Division, MDB, Regulatory Transparency and Laura Johnson, SBD Project Manager, Health Openness Canada Rebecca Bose, Policy Analyst, Collin Pinto, Manager, Medical Device Compliance Unit, Opening Remarks Learn more about recent changes and work in progress at. ToC Pilot (Canada and IMDRF) Electronic submissions Patient Registries Report Cards Inspection Transparency Inspection Deficiencies, Inspection Report Cards, Annual Inspection Summary Report. Other compliance related transparency initiatives underway 10:15 10:30 am Coffee Break 10:30 11:00 am Regulatory Requirements for Advertising 11:00 am 12:00 pm Human Factors Excellence for Medical Device Design 12:00 1:00 pm Lunch Alain Musende, Manager, Regulatory Advertising Section, MHPD, Tim Reeves, Managing Director, Human Factors MD Prabhu Ramachandran, Director R&D, POC, Siemens Deborah Chan, Human Factors Engineer, Healthcare Human Factors Overview of what constitutes advertising and best practices with a special focus on the Inspectorate s expectations and recommendations on guidance or practices that industry should follow. Overview of the relationship among human factors, risk management and regulatory affairs and how this is implemented into the design of a device. The session will also highlight why human factors is essential to maintaining patient safety.
3 1:00 1:30 pm Medical Device Software Nancy Shadeed, Special Advisor, International Programs Division, Bureau of Policy, Science and Discuss and define what factors constitute software as a medical device International Programs, Address confusion on distinction between what is a SaMD and software contained in a medical device Highlight regulatory challenges and next steps 1:30 3:15 pm Medical Device Cybersecurity 3:15 3:30 pm Coffee Break 3:30 3:45 pm Canadian Standards Association Tara Larson, Sr Principle Systems Engineer, Medtronic Dave Kleidermacher, Chief Security Officer, Blackberry Linda Lindsay, Chair, MEDEC Regulatory Affairs Committee Software risk classification, what constitutes a software change and requirements/factors that may want in support of S&E Cybersecurity and patient safety overview of how healthcare providers and industry are approaching challenges and risks Nancy Bestic, Program Manager, CSA Group Standards in Canada and activities of CSA National and international standards Overview of role of test houses/laboratories 3:45 4:05 pm Recognized Catherine Milley, Evaluator, MDB, Health Use of Standards by Standards Canada s process for updating the list of recognized standards 4:05 5:05 pm IEC60601 & Canadian Electrical Manoj Waghela, Certifier, CSA Group Overview of IEC family and impact on product (medical devices) safety Code 101 Overview of the Canadian Electrical Code nationally (specific to medical devices) 5:05 5:15 pm Wrap up and Q&A End of Day Two closing remarks. Any additional questions.
4 Wednesday, May 11, :30 am Registration and Breakfast 8:15 8:30 am Welcome to Anne Lamar, Assistant Deputy Minister, Regulatory Operations and Regions Branch, Opening Remarks 8:30 10:00 am Establishment Licensing & Inspection Process 10:00 10:15 am Coffee Break 10:15 11:45 am Quality Systems IS and MDSAP 11:45 12:45 pm Lunch Mark A Bailey, Compliance Specialist (Inspection Process), Collin Pinto, Manager, Medical Device Compliance Unit, Frederic Hamelin, Quality Systems Officer, MDB, Angie Combs, Technical Manager, Medical Devices, BSI Group Provide an update of activities at the Medical Device Complaint Unit including: Establishment licence inspections, common issues and best practices Provide information on Quality Management Systems to improve an understanding of regulatory requirements. Highlights include: ISO Overview, pending changes, and implementations Update to GD 210 Audit inspections from a registrar s perspective: common issues/best practices, company mergers and acquisitions Update on MDSAP and promoting approach to industry
5 12:45 1:45 pm Tips & Strategies for an Effective Submission from a Regulator Perspective Colin Foster, Regulatory Information Officer, Device Licensing Services Division, MDB, 1:45 2:45 pm Concurrent Breakout Sessions Bisi Lawuyi, Manager, Investigational Testing & Special Access Program, MDB, Dr Weimin Zhao, Section Head, Musculoskeletal Room 202 Kevin Day, Head, Cardiovascular Section Room 203 Maria Carballo, Head, In Vitro Diagnostic Devices (IVDD), Room 201 Classification/risk assessment Amendments/significant change Licence type with a focus on systems Complex org structures/business relationships and the impact to labelled legal manufacturer Intended use statements ITA common errors Open forum for questions and answers 2:45 3:00 pm Coffee Break 3:00 3:45 pm Tips for an Effective Submission from an Industry Perspective 3:45 4:00 pm Closing Remarks Constance Campbell, Section Head, General and Restorative Section, Room 205/207 Shirley Furesz, Sr. Manager, Regulatory Affairs (Medical Devices), MAPI Group Carey Agnew, Associate Director, MDB, Industry perspective on best practices Closing Remarks
2016 MEDEC Regulatory Conference MAY 9 11, 2016 DRAFT AGENDA
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