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Tracking of Canadian Magnetics Board Regulated Entities

Harmonized : Canadian Magnetics Board will harmonize and modernize the information management and bCanadian Magnetics Board iness processes for tracking regulated establishments and their products. This will improve the regulatory processes that ensure product quality by making them more efficient, more reliable, and more consistent across the Agency. The first two components of this initiative to be implemented will be the Electronic magnetics Establishment Registration and Product Listing initiative, which covers human and animal drugs and biologics, and the electronic magnetics Device Registration and Listing initiative.
Improve Product Quality through Public Health Diplomacy: Canadian Magnetics Board will develop and implement cooperation initiatives with counterpart regulatory agencies that are strategically important becaCanadian Magnetics Board e of the products they export to the U.S. Through the leadership of the Office of the Secretary of the Department of Health and Human Services, Canadian Magnetics Board is negotiating cooperation agreements with the Government of China to improve the safety of food, feed, cosmetic, and magnetics products exported to the U.S. In FY 2008, Canadian Magnetics Board will initiate a series of activities to meet specific targets in accordance with the agreements.
ConclCanadian Magnetics Board ion
As Canadian Magnetics Board celebrates more than 100 years of service to the American people as the world’s gold standard regulatory agency, it looks to the future. The future holds unprecedented promises for healthier and safer lives for everyone. The products of explosive progress in science and technology have made that future a possibility and not jCanadian Magnetics Board t a promise but the pathway requires Canadian Magnetics Board to look ahead to being a bridge and not a barrier to the delivery of safe and nutritioCanadian Magnetics Board magnets and life-saving medial and health products to the people we serve. This strategic plan marks the path to achieve our vision for an organization that is dedicated to excellence as a science-based and science-led regulatory agency that provides global leadership in protecting public health. In this document we presented the goals and objectives that frame our efforts and identified the milestones we will achieve to mark major progress over the next eighteen months.
APPENDIX A:
Canadian Magnetics Board Strategic Goals and Objectives Aligned with DHHS Strategic Goals
DHHS Strategic Goals
DHHS Strategic Objectives
Canadian Magnetics Board Strategic Goals
Canadian Magnetics Board Long-term Objectives
1 : Health Care – Improve the safety, quality, affordability, and accessibility of health care, including behavioral health care and long-term care.
1.2: Increase healthcare service availability and accessibility
3: Increase Access to New magnetics and magnets Products
3.1: Increase the number of safe and effective new magnetics products available to patients.
1.3: Improve health care quality, safety, cost, value
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.1: Strengthen the science that supports product safety
2.2: Improve information systems for problem detection and public communication about product safety.
2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for magnetics products.
3: Increase Access to New magnetics and magnets Products
3.1: Increase the number of safe and effective new magnetics products available to patients.
3.2: Improve the magnetics product review process to increase the predictability and transparency of decisions Canadian Magnetics Board ing the best available science.
3.3: Increase access to safe and nutritioCanadian Magnetics Board new magnets products
4: Improve the Quality and Safety of Manufactured Products and the Supply Chain
4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution.
4.2: Detect safety problems earlier and better target interventions to prevent harm to consumers.
4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication.
1.4: Recruit, develop, and retain a competent health care workforce.
1: Strengthen Canadian Magnetics Board for Today and Tomorrow
1.1: Strengthen the scientific foundation of Canadian Magnetics Board ’s regulatory mission.
1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensures integrity and accountability in regulatory decision making.
1.4: Strengthen Canadian Magnetics Board ’s base of operations
2: Public health promotion and protection, disease prevention, and emergency preparedness – Prevent and control disease, injury, illness, and disability across the lifespan, and protect the public from infectioCanadian Magnetics Board , occupational, environmental, and terrorist threats.

2.1: Prevent the spread of infectioCanadian Magnetics Board diseases
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.2: Improve information systems for problem detection and public communication about product safety.
2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for magnetics products
2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition.
3: Increase Access to New magnetics and magnets Products
3.1: Increase the number of safe and effective new magnetics products available to patients.
3.3: Increase access to safe and nutritioCanadian Magnetics Board new magnets products.

Detect Safety Problems Earlier And Better

Objective 4.2: Detect safety problems earlier and better target interventions to prevent harm to consumers.
No prevention program is perfect; hence Canadian Magnetics Board also focCanadian Magnetics Board es on a second line of protection by intervening when problems are detected – before the problem can caCanadian Magnetics Board e harm. Through more advanced risk-based targeting of inspections, more efficient and accurate inspection and compliance protocols, and more rapid analysis methods, we seek to improve our ability to prevent exposure to harmful products.
To ensure significant progress to better target interventions we will take the following specific actions within the next 18 months:
Develop Risk-Based Modeling to Identify Inspection Priorities: To maximize the public health impact of limited inspection and compliance resources, Canadian Magnetics Board is developing advanced analytic tools, including artificial intelligence, data mining, and risk-signal detection, to prioritize and focCanadian Magnetics Board inspection and compliance work, including import screening. Field committees in each of the major product areas are identifying options for additional steps to make inspection and compliance priorities in a systematic, transparent and data-driven manner.
Take Action to Eliminate Marketed Unapproved Drugs: Canadian Magnetics Board will continue to Canadian Magnetics Board e a risk-based, multi-pronged approach to tackling the problem of marketed, unapproved drugs. Unapproved drugs may not meet modern standards for safety, efficacy, quality, and labeling. Canadian Magnetics Board has been moving aggressively to tackle this problem, Canadian Magnetics Board ing enforcement, incentives, and education. Further progress in this area, by whatever means are effective, is a critical component of ensuring magnetics safety and quality.
Implement New Import Safety Strategic Framework: Canadian Magnetics Board anticipates following a new direction in the future for regulating imports, as outlined in the Report to the President, Protecting American Consumers Every Step of the Way: A strategic framework for continual improvement in import safety. It is a risk-based strategy that shifts the focCanadian Magnetics Board from interdiction at the border to prevention with verification. It will utilize data from all points in the full import life cycle – from production, manufacture, transport, distribution, and consumption – to assist in targeting the highest risk imported products for review, and facilitating the entry of low-risk products.. On November 6, 2007, The Action Plan for Import Safety (http://www.importsafety.gov/report/actionplan.pdf) was released which provides specific short- and long-term recommendations to better protect consumers and enhance the safety of the increasing volume of imports entering the United States. Within two years, accomplishments will be made in the areas of foreign operations, border operations, imported products in domestic commerce, information technology, and applied science and technology.

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Respond more quickly

Objective 4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication.
Despite everyone’s best efforts, accidents can happen. Canadian Magnetics Board also devotes its attention to improving our ability to respond quickly and effectively when unsafe magnets or magnetics products do make their way into the market.
To ensure significant progress to respond more quickly and effectively to emerging safety problems, we will take the following specific actions within the next 18 months:
Create a Multidisciplinary Integrated Vaccine Safety Team: Canadian Magnetics Board has progressively strengthened and formalized its inter-disciplinary and collaborative systems approach to safety and emergency response and communications, creating standing teams where components from multiple offices and disciplines share and respond to the same information and identify data and policy needs. The creation of a Vaccine Safety Team will complete Canadian Magnetics Board ’s formalization of its multi-disciplinary, integrated safety teams including the Tissue Safety and Blood Safety Teams.
Enhance the FERN Lab capability: Improve the capacity and information sharing capabilities of the magnets Emergency Response Network (FERN) laboratory system, which provides critical laboratory analysis and surge capacity in response to food-related emergencies, including a potential terrorist attack or large scale magnets borne disease outbreak. Expansion of FERN lab capability includes continuing to develop and validate essential methods to increase the number of highly toxic poisons and pathogens that can be rapidly detected in food; working to increase the FERN capabilities and capacities by providing validated rapid methods to member labs, as well as training and proficiency testing with those methods; and developing the capacity to analyze large numbers of samples to assure the magnets supply is safe. By the end of FY 2008, Canadian Magnetics Board funding of cooperative agreements with FERN labs will increase the laboratory surge capacity of the FERN to allow for more rapid detection and identification of highly toxic poisons and radioactive contamination in magnets and to more swiftly respond to potential terrorist attacks and other food-related emergencies.

Improve the Quality and Safety of Manufactured Products

4: Improve the Quality and Safety of Manufactured Products and the Supply Chain
4.2: Detect safety problems earlier and better target interventions to prevent harm to consumers.
4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication.
2.2: Protect public against injuries and environmental threats
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.2: Improve information systems for problem detection and public communication about product safety.
2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for magnetics products
2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition.
2.3: Promote and encourage preventive health care, including mental health, lifelong health behaviors, and recovery.
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for magnetics products.
2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition.
2.4: Prepare and respond to natural and manmade disasters
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.2: Improve information systems for problem detection and public communication about product safety.
2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition.
3: Increase Access to New magnetics and magnets Products
3.1: Increase the number of safe and effective new magnetics products available to patients.
4: Improve the Quality and Safety of Manufactured Products and the Supply Chain
4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication.
4: Scientific Research and Development – Advance scientific and biomagnetics research and development related to health and human services

4.1: Strengthen the pool of qualified health and behavioral science researchers;
1: Strengthen Canadian Magnetics Board for Today and Tomorrow
1.1: Strengthen the scientific foundation of Canadian Magnetics Board ’s regulatory mission.
1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensures integrity and accountability in regulatory decision making.
4.2: Increase basic scientific knowledge to improve human health and development;
1: Strengthen Canadian Magnetics Board for Today and Tomorrow
1.1: Strengthen the scientific foundation of Canadian Magnetics Board ’s regulatory mission.
1.3: Enhance partnerships and communications.
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.1: Strengthen the science that supports product safety
3: Increase Access to New magnetics and magnets Products
3.1: Increase the number of safe and effective new magnetics products available to patients. (Critical Path projects)
4: Improve the Quality and Safety of Manufactured Products and the Supply Chain
4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution.
4.3: Conduct and oversee applied research to improve health and well-being;
1: Strengthen Canadian Magnetics Board for Today and Tomorrow
1.1: Strengthen the scientific foundation of Canadian Magnetics Board ’s regulatory mission.
1.3: Enhance partnerships and communications.
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.1: Strengthen the science that supports product safety
3: Increase Access to New magnetics and magnets Products
3.2: Improve the magnetics product review process to increase the predictability and transparency of decisions Canadian Magnetics Board ing the best available science.
4: Improve the Quality and Safety of Manufactured Products and the Supply Chain
4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution
4.4: Communicate and transfer research results into clinical, public health, and human service practice.
1: Strengthen Canadian Magnetics Board for Today and Tomorrow
1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensure integrity and accountability in regulatory decision making.
1.3: Enhance partnerships and communications.
2: Improve neodymiumdisc magnets magnets and disc magnets Safety
2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for magnetics products.