2016 MEDEC Regulatory Conference – MAY 9

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2016 MEDEC Regulatory Conference – MAY 9‐11, 2016 DRAFT AGENDA (subject to change) Monday, May 9, 2016 TIME SESSION CHAMPION/LEADER 1:30 pm Registration and Coffee 2:30 – 2:45 Welcome to Conference Massoma Haidry, GE Healthcare 2:45 – 3:15 Certification and Compliance Requirements for Medical Device Radio Apparatus Althea Lawrence, Philips SPEAKER(S) DETAILED DESCRIPTION  Klaus Stitz, VP Regulatory Affairs, MEDEC  HPFB Representative (TBD)  Linda Lindsay, Chair, MEDEC Regulatory Affairs Committee Jean‐Claude Brien, Director, Certification & Engineering Bureau Brief welcome as the official Opening Remarks will take place on Tuesday, May 10. May change depending on the nature of the session Part 2. Hughes Nappert, Manager, Regulatory Standards 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. Nicolas Desmarais, Manager, Certification & Market Surveillance Innovation Science & Economic Development Canada 3:15 – 5:00 Reprocessing of SUDs Sterilization of Medical Devices La‐Toya Salmon, Stryker Karen Kennedy, Scientific Evaluator, Cardiovascular Devices, MDB Health Canada’s requirements around licensing of reprocessed SUDs Rod Parker, Sr. Principle Scientist, Stryker General overview of the process around validation methods used during product development of sterile medical devices Tuesday, May 10, 2016 TIME SESSION CHAMPION/LEADER 8:00 am Registration and Breakfast 8:30 – 8:45 am Welcome to Conference Massoma Haidry, GE Healthcare 8:45 – 9:15 What’s New at Health Canada Greg LeBlanc, Cook Medical 9:15 – 10:15 Health Canada Regulatory Transparency and Openness Dinar Suleman, LifeScan 10:15 – 10:45 Regulatory Requirements for Advertising Dinar Suleman, LifeScan 10:45 – 11:00 Coffee Break 11:00 – 12:00 Human Factors Excellence for Medical Device Design Nana Dankwa, Siemens SPEAKER(S) DETAILED DESCRIPTION  Klaus Stitz, VP Regulatory Affairs, MEDEC  HPFB representative  Linda Lindsay, Chair, MEDEC Regulatory Affairs Committee TBD – Health Canada Opening Remarks – may change depending on day before. Learn more about recent changes and work in progress at Health Canada.  UDI  Bill C‐17 status of initiatives  ToC Pilot (Canada and IMDRF)  Electronic submissions  Patient Registries  Health Canada Report Cards Collin Pinto ‐ A/Manager, Medical Device Overview of Health Canada’s initiatives and goals around Compliance Unit regulatory transparency, highlighting:  Initial inspection deficiency (IID)  Annual Inspection Summary Report (AISR)  Summary Safety Reports (SSR) TBD ‐ MHPD 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. Tim Reeves, Managing Director, Human Overview of the relationship among human factors, risk Factors MD management and regulatory affairs and how this is implemented into the design of a device. The session will Prabhu Ramachandran, Director R&D, also highlight why human factors is essential to POC maintaining patient safety. Deborah Chan, Human Factors Engineer, Healthcare Human Factors TIME SESSION 12:00 – 1:00 pm Lunch 1:00 – 1:30 Medical Device Software 1:30 – 3:15 Medical Device Cybersecurity 3:15 – 3:30 Coffee Break 3:30 – 4:00 Canadian Standards Association Recognized Standards 4:00 – 4:15 4:15 – 5:15 IEC60601 and Canadian Electrical Code 101 CHAMPION/LEADER SPEAKER(S) DETAILED DESCRIPTION Akhil Shah, Medtronic Nancy Shadeed, Special Advisor, International Programs Division, Bureau of Policy, Science and International Programs Discuss and define what factors constitute software as a medical device  Address confusion on distinction between what is a SaMD and software contained in a medical device  Highlight regulatory challenges and next steps Akhil Shah, Medtronic  Tara Larson, Sr Principle Systems Engineer, Medtronic  Dave Kleidermacher, Chief Security Officer, Blackberry Marisa Petrielli, Consultant TBD: CSA Marisa Petrielli, Consultant Catherine Milley, Evaluator, MDB Marisa Petrielli, Consultant TBD: CSA Software risk classification, what constitutes a software change and requirements/factors that Health Canada may want in support of S&E Cybersecurity and patient safety – overview of how healthcare providers and industry are approaching challenges and risks Standards in Canada and activities of CSA  National and international standards  Overview of role of test houses/laboratories  Use of Standards by Health Canada  Health Canada’s process for updating the list of recognized standards 
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Overview of IEC 60601 family and impact on product (medical devices) safety Overview of the Canadian Electrical Code nationally (specific to medical devices) Function of both standards – overlap? Wednesday, May 11, 2016 TIME SESSION CHAMPION/LEADER 8:00 am Registration and Breakfast 8:30 – 10:00 Establishment Licensing & Inspection Process 10:00 – 10:15 Coffee Break 10:15 – 11:45 Quality Systems IS0 13485 and MDSAP 11:45 – 12:45 Lunch 12:45 – 1:45 MDB performance; Tips & Strategies for an Effective Submission Young Kim, Johnson & Johnson 1:45 – 2:45 Breakout sessions: CV; G&R; IVD; MS Young Kim, Johnson & Dr Weimin Zhao ‐ Section Head, Johnson Musculoskeletal Kevin Day ‐ Head, Cardiovascular Section Isabelle Gerges, Medtronic SPEAKER(S) DETAILED DESCRIPTION Provide an update of activities at the Medical Device Julie Robert ‐ A/Manager, Establishment Licensing, Billing and Complaint Unit including: Invoicing Unit (Establishment Licensing  Establishment licence inspections, common issues only) and best practices Mark A Bailey ‐ Compliance Specialist  Updates and changes to Mandatory Problem (Inspection Process) Reporting  Update on post‐market data collection Camille Yeung, Valeant Frederic Hamelin, Quality Systems Officer, MDB (ISO 13485) Angie Combs, Technical Manager, Medical Devices, BSI Group  Colin Foster, Regulatory Information Officer, Device Licensing Services Division, MDB  Bisi Lawuyi, Manager, Investigational Testing & Special Access Program, MDB Goal is to provide information on Quality Management Systems to improve an understanding of regulatory requirements. Highlights include:  ISO 13485 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 Time to Market and performance data review General overview of the process around the management of application files, highlighting:  Licence Application Types  Novel Technology  Clinical Studies/ Investigational Testing  Exceptions of interoperability and device compatibility  Foreign guidances recognized by Health Canada  Common submission deficiencies  Regulator perspective on how industry can improve the quality of submissions TIME sections 2:45 – 3:00 Coffee Break 3:00 – 3:45 Tips for an Effective Submission Conference Closing Remarks 3:45 SESSION CHAMPION/LEADER SPEAKER(S) Maria Carballo – Head, IVDD, MDB Constance Campbell ‐ Section Head, General and Restorative Section Young Kim, Johnson & Johnson Massoma Haidry, GE Healthcare Shirley Furesz, Sr. Manager, Regulatory Affairs (Medical Devices) Carey Agnew, Associate Director, MDB, Health Canada Klaus Stitz, VP Regulatory Affairs, MEDEC DETAILED DESCRIPTION Industry perspective on best practices Closing Remarks 

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