ITAC Health and MEDEC invite you to an educational conference on Health Canada's recently released Patient Management Software Notice - save the date!
When: Wednesday, September 8, 2010
Where: Allstream Centre, Exhibition Place, 105 Princes' Blvd., Room 200 A/B/C, Toronto, ON, M6K 3C3
|8:15 am||Registration and light breakfast|
|8:45 am||Opening Remarks|
|9:00 am||"Patient Management Software Notice Licensing Requirements" (Sarah Chandler, Health Canada)|
|10:00 am||Coffee Break|
|10:15 am||"Customer Point of View" presentation and panel discussion (Neil Gardner, Saskatchewan Health; Lydia Lee, University Health Network Toronto; William Pascal, Canadian Medical Association)|
|11:15 am||"Navigating the Licensing Process" vendor panel (Joe Whitney, MedManager; Laila Gurney, GE Healthcare)|
|12:15 pm||Lunch and networking|
|1:15 pm||Preparing for "ISO 13485:2003 CMDCAS" (Dion Goncalves, Intertek)|
|2:15 pm||Closing Remarks|
|2:30 pm||Workshop concludes|
A/Head, Regulatory and Scientific Section
Device Licensing Services Division
Medical Devices Bureau
Graduated from Carleton University in 2004 with a degree in Electrical Engineering.
From 2004-2005 worked as a Continuous Improvement Facilitator helping to implement "lean" processes at Volex Canada, Inc.
From 2005-2008 worked as a Regulatory Information Officer at the Medical Devices Bureau.
From 2008-present acted as the Head of the Regulatory and Scientific Section. In this position I routinely provide regulatory interpretation to stakeholders and have been involved in the Patient Management Software initiative since it began last year.
Chief Information Officer
As the Chief Information Officer for Saskatchewan Health, Neil Gardner works closely with staff of the Health Information Solutions Centre in collaborating with health system stakeholders to establish strategic plans, architectures and standards guiding health information technology developments in the province. Neil is a director of COACH (Canada’s Health Informatics Association) and the lead for COACH’s Health Informatics Professionalism initiative. In the past he has served as a founding director for both the Canadian Institute for Health Information and Canada Health Infoway. Through his active participation on a number of provincial, national and international groups, Neil believes strongly in the need for a collaborative approach in successfully introducing IT and enabling change in health care delivery. Neil holds a Master in Public Administration (MPA) degree from Harvard University where he was distinguished in his academic achievements by being named a Littauer fellow.
Dion Goncalves has been a professional in the ISO Quality industry since 2002. He joined Intertek in January 2008, to take on the role of Canadian Manager. His executive experience was established at an early stage when he was involved in selling investment and insurance solutions to large multi-national companies. Dion has more than 5 years of senior management experience in Quality management standards, auditing and certification services with some of the largest registrars globally. He has been a key member in the development and launch of Intertek’s North American training programs which includes the following industries; Medical, Aerospace, Food and the Environment. His passion for languages has propelled him to learn and speak 5 languages fluently.
Director, Regulatory Affairs
GE Healthcare Canada
Laila Gurney is the Director, Regulatory Affairs at GE Healthcare Canada. In this role, she is responsible for pre-market submissions, post-market reporting, regulatory intelligence and compliance with the Canadian Regulations. Prior to joining GE, Ms. Gurney was the Director, Clinical, Quality and Regulatory Affairs at PreMD Inc., where she was responsible for the company’s global clinical trials, regulatory submissions in Canada, US and EU and for establishing and maintaining certification to ISO 13485:2003.
Laila Gurney has a Master of Science in biochemistry from McGill University and is RAC certified. Ms. Gurney is on study group 3 of GHTF. She is and an active member of RAPS and MEDEC.
Vice President & CIO, University Health Network
Integrated CIO, Shared Information Management Services
Lydia Lee is the Vice President and Chief Information Officer for University Health Network (UHN), a leading multi-site acute care teaching hospital in Toronto. In this role, Lydia provides strategic leadership in the areas of information management, information technology, privacy, medical engineering and human factors engineering support services. Lydia has been at UHN for more than six years serving in several different leadership roles focusing on clinical integration, performance improvement, patient safety and health system redesign.
In addition to her UHN responsibilities, Lydia is the Integrated Chief Information Officer for the Shared Information Management Services (SIMS) Partnership – a collaboration of health care provider organizations that span the continuum of care in Toronto. These organizations work together to transform health care delivery by leveraging information management and technology. The SIMS Partnership includes: Providence Health Care, St. John’s Rehab, Toronto Central Community Care Access Centre, Toronto Rehabilitation Institute, University Health Network, West Park Health Care and Women’s College Hospital.
Lydia is currently the President and Board of Directors Chair with COACH: Canada’s Health Informatics Association. COACH represents a diverse community of accomplished, influential professionals who work passionately to make a difference in advancing healthcare through information technology.
Previously, Lydia has held numerous positions in healthcare administration and consulting, focusing on strategic alliances, integrated health system planning, large-scale project management and evidence-based health care. Lydia received her B.A. in Economics from Northwestern University in Evanston, Illinois and her M.B.A. in Finance and Management from the University of Texas.
William (Bill) Pascal
Chief Technology Officer
Canadian Medical Association
Mr. Pascal is the Chief Technology Officer for the Canadian Medical Association where he has responsibility for shaping the strategic direction and policy for the CMA’s e-Health agenda.
He has worked in the economic policy and social policy sectors at the Federal government level as well as run operations in regional and headquarter environments.
He has developed air, railway and marine transportation policies as well as built airports throughout the north and negotiated ferry service contracts on both coasts of Canada. He has been responsible for communications policy while at the Privy Council Office and in Health Canada. He has developed health policies and managed the Central Region operations for Health Canada which included Ontario, Manitoba and Saskatchewan. He has managed several large projects, most notably, the Federal government’s involvement at Expo 86 in Vancouver and at the 1988 XV Olympic Winter Games in Calgary. Most recently he was the Director General, Office of Health and Information Highway which had responsibility for co-ordinating, facilitating and managing health infostructure-related activities both within Health Canada, with other Federal government departments, with all the provinces and territories and other stakeholders. His work led to an agreement on Information Technology investments in the health care sector in Canada with all provinces and territories and the creation of Canada Health Infoway.
He is an electrical engineer, certified management accountant and urban planner by academic training.
In 2001 he received the Lieutenant Governor’s Medal of Distinction in Public Administration for his work as Chair of the Federal Council in Ontario.
Vice-President, Marketing & Public Affairs
MedManager Interactive Corp.
As Vice-President of Marketing & Public Affairs at MedManager Interactive Corp., Joe is responsible for the promotion and implementation of the company’s online chronic disease management solutions. MedManager’s consumer-focused portals provide individuals and healthcare professionals with the information, monitoring and communication tools needed to manage chronic diseases such as diabetes, heart failure and asthma. The company’s Live Well. Connected. portals are currently being used in retirement community, hospital clinic and education centre settings. Since 2006, Joe has also lead MedManager’s efforts to successfully deploy an ISO 13485-certified quality system and obtain a Class 2 medical device license from Health Canada, becoming the first “patient portal” company to achieve full regulatory compliance in Canada.
In addition to his work at MedManager, Joe has spent the past 12 years in various roles within and around the healthcare sector, including as a consultant to the Canadian Diabetes Association and Astra Zeneca Canada, as a health policy analyst with GlaxoSmithKline Canada, and as a Special Assistant to senior officials at the Workplace Safety & Insurance Board and the Ontario government’s Ministry of Health & Long Term Care and Management Board of Cabinet.
Joe is a graduate of the University of Western Ontario and Wilfrid Laurier University, and holds Master of Arts and Master of Business Administration degrees.
This conference will also provide an excellent opportunity to network with others working through the process.
ITAC Health, MEDEC, and COACH members - $175 plus HST
Non-members - $225 plus HST
Click here to access Joe Whitney's presentation.
Click here to access Sarah Chandler's presentation.
Click here to access Dion Goncalves' presentation.
Click here to access Laila Gurney's presentation.
The following are a selection of photos from this event: