Traduction de «Bureau Drug Quality Assessment » (Anglais → Français) :

A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle

Question No. 609 Ms. Anne Minh-Thu Quach: With respect to drug regulation and approval: (a) does the 2012 Economic Action Plan provide for decreases or increases in the financial and human resources allocated to (i) drug approval services, (ii) regulatory activities to evaluate and monitor the safety, efficacy and quality of drugs before and after they enter the marketplace, (iii) activities related to the review of submissions by drug manufacturers for market authorization and post-market changes, (iv) activities related to enforcing ...[+++] compliance with existing regulations, including those concerning clinical trials, drug manufacturing and the reporting of adverse drug reactions, (v) activities of the Patented Medicine Prices Review Board, (vi) services such as the Patent Register, Drug Product Database, Notice of Compliance, and Progressive Licensing Project, (vii) various areas of Health Canada such as the Marketed Health Products Directorate, Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, and the Veterinary Drugs Directorate; (b) for each of the programs and directorates listed in (a), (i) what is the estimated extent of the decreases or increases in human or financial resources, (ii) are positions expected to be cut and, if so, how many will be eliminated; (c) was a value-for-money assessment conducted for the drug approval process; and (d) what is the government’s financial allocation plan regarding drug regulation?

Scale up the development, availability and coverage of drug demand reduction measures in prison settings, as appropriate and based on a proper assessment of the health situation and the needs of prisoners, with the aim of achieving a quality of care equivalent to that provided in the community and in accordance with the right to health care and human dignity as enshrined in the European ...[+++] Convention on Human Rights and the EU Charter of Fundamental Rights.

(Return tabled) Question No. 864 Ms. Kirsty Duncan: With respect to mental health and suicide in the Canadian Forces (CF), including regular forces, reservists and veterans, as well as among Royal Canadian Mounted Police (RCMP) veterans: (a) what does history and research show from the First World War (WWI) and the Second World War (WWII), regarding the percentage of Canadian veterans who suffered some degree of Post Traumatic Stress Disorder (PTSD) and how it might have impacted their ability to (i) hold down jobs, (ii) maintain relationships, (iii) overcome substance abuse, (iv) maintain their will to live; (b) how are suicides tracke ...[+++]d for CF regular forces, reservists and veterans, including RCMP veterans, (i) has the tracking method changed over time (from 2000 onwards) for any of these groups, including name changes (e.g., suicide versus sudden death) and, if so, how, why and when, (ii) how are suicides tracked among veterans who may not be known to Veterans Affairs Canada (VAC) and who may be under other types of care (e.g., in hospitals) or in homeless shelters, prisons, etc.; (c) what are the identified gaps in tracking for each of the identified groups and, for each gap, what action items (i) are planned (including predicted start and completion dates, and necessary funding), (ii) are being implemented (including predicted completion date and necessary funding), (iii) have been completed to address the problem; (d) how are suicides investigated for each identified group today and, for each group, for the years 1990 to the present (or years available), (i) what percentage of victims were known to either the Department of National Defense (DND) or VAC prior to the suicide, or to the medical, social-aid or prison system, (ii) what percentage had attempted suicide before, (iii) what percentage suffered from an identified Operational Stress Injury (OSI), including PTSD, anxiety, depression or substance abuse, (iv) what percentage suffered from acquired brain ...

As a regulator of prescription drugs, we are responsible for assessing the safety and efficacy of the quality of drugs and products that are sold in Canada.

Question No. 397 Ms. Kirsty Duncan: With respect to initiatives and programs run by the Department of National Defence (DND) and Veterans Affairs Canada (VAC) in relation to veterans’ health and welfare: (a) what are the issues affecting (i) Canada’s traditional war veteran population, (ii) Canadian Forces (CF) veterans; (b) for each group of veterans in (a), how many cases were there per identified issue, per year, over the last five years; (c) for each group of veterans in (a), what changes have occurred in the issues over the last five years; (d) for CF veterans, what key issues are anticipated following the withdrawal from Afghanistan in 2011, and for each anticipated issue, what are the (i) challenges, (ii) changes necessary to VAC, ...[+++] (iii) actions taken to date; (e) what recommendations, if any, have been made to improve the quality of life for veterans identified in (a) and what steps, if any, have been taken to address these recommendations; (f) what specific measures are being taken to ensure that VAC (i) responds quickly to emerging research, such as the possible link between combat and amyotrophic lateral sclerosis, and combat and dementia, (ii) implements research recommendations in a timely manner; (g) what are the categories of injuries sustained by the Canadian troops in Afghanistan; (h) what specific rehabilitation is provided for each injury category, by region; (i) what reviews of rehabilitation procedures have been undertaken, by date and region; (j) for each injury category identified in (g), what percentage of veterans are able to return to civilian work; (k) what specific measures are undertaken by region to help veterans normalize to civilian life; (l) what specific measures are used to ensure veterans returning from Afghanistan are informed of veterans' benefits; (m) what is the process for acquiring the help of a case manager; (n) what are the specific steps a veteran needs to take following a release or a medical release in order ...