Purchasing:Health Canada Communication Tools - Revision history

Johnt at 20:59, 7 August 2019

2019-08-07T20:59:15Z

Johnt at 20:49, 7 August 2019

2019-08-07T20:49:07Z

Johnt at 20:31, 7 August 2019

2019-08-07T20:31:46Z

Johnt at 20:29, 7 August 2019

2019-08-07T20:29:48Z

Johnt at 20:28, 7 August 2019

2019-08-07T20:28:44Z

Johnt at 20:23, 7 August 2019

2019-08-07T20:23:57Z

Johnt at 20:21, 7 August 2019

2019-08-07T20:21:15Z

Johnt at 20:19, 7 August 2019

2019-08-07T20:19:49Z

Johnt at 20:18, 7 August 2019

2019-08-07T20:18:47Z

Johnt: /* 1.Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications) */

2019-08-07T20:16:23Z

1.Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)

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 *'''Canada Vigilance Adverse Reaction Online Database'''
 * The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse drug reactions reported to Health Canada by consumers, health professionals and market authorization holders.
@@ Line 98: / Line 99: @@
 * Drug Product Database
 - https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

← Older revision		Revision as of 20:49, 7 August 2019
Line 93:		Line 93:

	- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html		- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html
		+
		+	=== 5. '''General Health Canada websites'''===
		+
		+	* Drug Product Database
		+	- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
		+

@@ Line 1: / Line 1: @@
 == '''Health Canada Communication Tools''' ==
-''These four categories of communication tools include a few documents that may or may not be familiar to you. If the document is unfamiliar, you will have an opportunity to share this with the interviewer. We have provided links and descriptions for your reference.''
+''These four categories of communication tools include a few documents that may or may not be familiar to industry.  These links and descriptions have been provided for your reference.''
 === 1.''' Guidance and regulations (Guidance Documents, guidelines and all regulation-related communications)'''===
 * Industry and other healthcare professionals have specific guidance and regulations they must adhere to in order to meet Health Canada’s requirements. If you are a healthcare professional, or represent industry, these may be familiar to you. Please see the links below for examples of such guidance.

← Older revision		Revision as of 20:29, 7 August 2019
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	- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html		- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-database.html
		+
		+
		+	[[Category: Purchasing]]

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 * Health Canada sometimes needs to recall a product that is on the market, or issue a safety alert. There are several ways these recalls and safety notices are communicated. These are detailed below.
-** a) Health Product Risk Communications (HPRC’s): Includes three types of communications
+** a) '''Health Product Risk Communications (HPRC’s)''': Includes three types of communications
-*** o Dear Healthcare Professional Letter (DHCPL);
+*** - Dear Healthcare Professional Letter (DHCPL);
-*** o Public communication; and,
+*** - Public communication; and,
-*** o Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
+*** - Notice to hospitals. (Type I risk: 48 hours - Type II risk 2-10 days). Communications are targeted to healthcare professionals, mainly written by industry and endorsed by Health Canada.
-** b) Information Updates: Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
+** b) '''Information Updates''': Health Canada’s communication for less urgent risk issues, e.g., some labelling updates, can take anywhere from 2-3 days to a week or more.
-** c) Public advisory: Health Canada’s communication to warn the public of a potential hazard.
+** c) '''Public advisory''': Health Canada’s communication to warn the public of a potential hazard.
-** d) Recall notice: This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
+** d) '''Recall notice''': This communication is written and distributed by Industry. An “extract” of the information is posted by Health Canada at regular intervals on Health Canada’s Recalls and Safety Alerts website link (see below).
-** e) Foreign product alert: Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
+** e) '''Foreign product alert''': Health Canada’s communication related to unauthorized products from other countries which may have been brought into the country by travellers or purchased online.
 * You can search for recalls and safety alerts through this link:
@@ Line 46: / Line 46: @@
 '''Product Monographs'''
-*A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
+* A Product Monograph is a factual, scientific document on a drug product that describes the properties, claims, indications, and conditions of use of the drug, and contains any other information that may be required for optimal, safe and effective use of the drug.
 - https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
@@ Line 70: / Line 70: @@
 - https://hpr-rps.hres.ca/reg-content/summary-safety-review-result.php?lang=en&term=
-'''New Safety and Effectiveness Reviews'''
+*'''New Safety and Effectiveness Reviews'''
 *Health Canada posts lists of new safety reviews to increase transparency with Canadians and inform them of the products and risks that Health Canada is assessing. Once a new safety and effectiveness review is completed, an SSR (see above) is published to inform Canadians of what was found and what action was taken by Health Canada, if any.
@@ Line 76: / Line 76: @@
 - https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/new.html
-Medical Devices Online Incidents Database
+*'''Medical Devices Online Incidents Database'''
-The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.
+* The Medical Device Online Incidents Database is an online initiative for reporting adverse reactions to medical devices. It contains medical device incident reports and information regarding recalls in a user-friendly, searchable, online format. There is also a full data extract available for download.

@@ Line 19: / Line 19: @@
 '''Health Product InfoWatch'''
-This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
+* This is a Health Canada monthly publication to raise awareness and to provide clinically relevant information to healthcare professionals concerning marketed health products and their safety. In some cases, information is intended to stimulate reporting of similar adverse reactions.
--https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
+- https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch.html
 '''Recalls and Safety Alerts'''

@@ Line 7: / Line 7: @@
 - https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
 === 2.''' Risk communications'''===
-Risk Communication tools may also be familiar to healthcare professionals:
+* Risk Communication tools may also be familiar to healthcare professionals:
 '''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
 * The CMDSNet issues a monthly bulletin to keep the members of the network aware of a number of items related to adverse events associated with medical devices. For instance: updates to the program, recent reports of adverse events, recent regulatory actions and outcomes which have resulted from their reports, lessons learned, highlighted issues, recently completed and upcoming safety reviews, and educational opportunities. A list of all reports submitted to the Network is also included with the monthly bulletin. '''The distribution of the bulletin and list of reports is limited to Health Canada and those in the CMDSNet, and are not to be distributed beyond the Network, and therefore, no example is provided.'''

@@ Line 6: / Line 6: @@
 - https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html for examples of advertising regulations.
-#'''Risk communications'''
+=== 2.''' Risk communications'''===
 Risk Communication tools may also be familiar to healthcare professionals:
 '''Canadian Medical Devices Sentinel Network Bulletin (CMDSNet)'''
@@ Line 39: / Line 39: @@
 - http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php?cat=3
-#'''Health Product Safety Information'''
+===3. '''Health Product Safety Information'''===
 * Health Product Safety Information tools may also be familiar to healthcare professionals and industry:
@@ Line 60: / Line 60: @@
 - https://hpr-rps.hres.ca/index.php?lang=en
-#'''Communications around Transparency/Transparency Initiatives for the Public'''
+=== 4. '''Communications around Transparency/Transparency Initiatives for the Public'''===
 * Transparency tools may also be familiar to healthcare professionals and industry: