2016 MEDEC Regulatory Conference MAY 9 11, 2016 DRAFT AGENDA

Transcription

1 2016 Regulatory Conference MAY 9 11, 2016 DRAFT AGENDA (subject to change) Monday, May 9, :30 pm Registration and Coffee 2:30 2:45 Welcome to Conference 2:45 3:15 Certification and Compliance Requirements for Medical Device Radio Apparatus 3:15 5:00 Reprocessing of SUDs Sterilization of Medical Devices Althea Lawrence, Philips La Toya Salmon, Stryker Klaus Stitz, VP Regulatory Affairs, HPFB Representative (TBD) Linda Lindsay, Chair, Regulatory Affairs Committee Jean Claude Brien, Director, Certification & Engineering Bureau Hughes Nappert, Manager, Regulatory Standards Nicolas Desmarais, Manager, Certification & Market Surveillance Innovation Science & Economic Development Canada Karen Kennedy, Scientific Evaluator, Cardiovascular Devices, MDB Rod Parker, Sr. Principle Scientist, Stryker 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. 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. Health Canada 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, :00 am Registration and Breakfast 8:30 8:45 am Welcome to Conference 8:45 9:15 What s New at Health Canada 9:15 10:15 Health Canada Regulatory Transparency and Openness Greg LeBlanc, Cook Medical Dinar Suleman, LifeScan Klaus Stitz, VP Regulatory Affairs, HPFB representative Linda Lindsay, Chair, Regulatory Affairs Committee TBD Health Canada Collin Pinto A/Manager, Medical Device Compliance Unit 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 Overview of Health Canada s initiatives and goals around regulatory transparency, highlighting: Initial inspection deficiency (IID) Annual Inspection Summary Report (AISR) Summary Safety Reports (SSR) 10:15 10:45 Regulatory Requirements for Advertising Dinar Suleman, LifeScan 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. 10:45 11:00 Coffee Break 11:00 12:00 Human Factors Excellence for Medical Device Design Nana Dankwa, Siemens Tim Reeves, Managing Director, Human Factors MD Prabhu Ramachandran, Director R&D, POC Deborah Chan, Human Factors Engineer, Human Factors 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 12:00 1:00 pm Lunch 1:00 1:30 Medical Device Software Akhil Shah, 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 1:30 3:15 Medical Device Cybersecurity 3:15 3:30 Coffee Break 3:30 4:00 Canadian Standards Association 4:00 4:15 Recognized Standards Akhil Shah, Tara Larson, Sr Principle Systems Engineer, Dave Kleidermacher, Chief Security Officer, Blackberry 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 TBD: CSA Standards in Canada and activities of CSA National and international standards Overview of role of test houses/laboratories Catherine Milley, Evaluator, MDB Use of Standards by Health Canada Health Canada s process for updating the list of recognized standards 4:15 5:15 IEC60601 and Canadian Electrical Code 101 TBD: CSA Overview of IEC family and impact on product (medical devices) safety Overview of the Canadian Electrical Code nationally (specific to medical devices) Function of both standards overlap?

4 Wednesday, May 11, :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 IS and MDSAP 11:45 12:45 Lunch 12:45 1:45 MDB performance; Tips & Strategies for an Effective Submission 1:45 2:45 Breakout sessions: CV; G&R; IVD; MS Isabelle Gerges, Julie Robert A/Manager, Establishment Licensing, Billing and Invoicing Unit (Establishment Licensing only) Mark A Bailey Compliance Specialist (Inspection Process) Camille Yeung, Valeant Frederic Hamelin, Quality Systems Officer, MDB (ISO 13485) Young Kim, & Young Kim, & 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 Dr Weimin Zhao Section Head, Musculoskeletal Kevin Day Head, Cardiovascular Section Provide an update of activities at the Medical Device Complaint Unit including: Establishment licence inspections, common issues and best practices Updates and changes to Mandatory Problem Reporting Update on post market data collection Goal is to 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 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

5 sections Maria Carballo Head, IVDD, MDB Constance Campbell Section Head, General and Restorative Section 2:45 3:00 Coffee Break 3:00 3:45 Tips for an Effective Submission 3:45 Conference Closing Remarks Young Kim, & Shirley Furesz, Sr. Manager, Regulatory Affairs (Medical Devices) Carey Agnew, Associate Director, MDB, Health Canada Klaus Stitz, VP Regulatory Affairs, Industry perspective on best practices Closing Remarks