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Found 10 records similar to Guidance Document - Periodic Benefit-Risk Evaluation Report (PBRER) International Conference on Harmonisation (ICH) Topic E2C(R2)

Federal

Section C.01.018 of Division 1 of the Food and Drug Regulations requires the Market Authorization Holder (MAH) to analyze adverse drug reaction data and prepare an annual summary report. Annual summary reports are to be submitted when requested by Health Canada. In addition, Section C.01.018(4) requires that the MAH notify Health Canada without delay if there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report.

Last Updated: Jul. 7, 2021
Date Published: Apr. 10, 2013
Organization: Health Canada
Formats: HTML
Keywords:  Notice, adoption of the International Conference on Harmonisation, ICH, guidance on Periodic Benefit Risk Evaluation Report, ICH Topic E2C(R2), market authorization holder, adverse drug reaction data, adverse drug reaction annual summary report
Federal

Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to each bi-annual ICH face-to-face meeting, in order to seek input on certain regulatory aspects that could be beneficial for the harmonisation of ICH guidelines.

Last Updated: Dec. 29, 2021
Date Published: Aug. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  HC, USA Food and Drug Administration, Joint Public Consultation, International Council for Harmonisation, ICH, Technical Requirements, Pharmaceuticals for Human Use
Federal

Guidance Document.

Last Updated: Jun. 7, 2022
Date Published: Nov. 3, 2015
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data, Sample Coding Categories, ICH Topic E15
Federal

Main-track derailment, Canadian National Railway Company, Freight train G83342-24, Mile 24.30, Wainwright Subdivision, Landis, Saskatchewan, 26 September 2018

Last Updated: Feb. 21, 2022
Date Published: Jul. 9, 2019
Organization: Transportation Safety Board of Canada
Formats: PDF HTML
Keywords:  safety investigation report
Federal

This report provides information on the annual expenditures for each of travel, hospitality and conference fees for FINTRAC for the fiscal year ending March 31, 2021

Last Updated: Mar. 17, 2022
Date Published: Feb. 1, 2022
Organization: Financial Transactions and Reports Analysis Centre of Canada
Formats: HTML
Keywords:  Financial Transactions and Reports Analysis, FINTRAC, expenditures; annual report; access to information; travel; hospitality; conferences
Federal

This report provides information on the annual expenditures for each of travel, hospitality and conference fees for FINTRAC for the fiscal year ending March 31, 2020

Last Updated: Mar. 14, 2022
Date Published: Dec. 7, 2020
Organization: Financial Transactions and Reports Analysis Centre of Canada
Formats: HTML
Keywords:  Financial Transactions and Reports Analysis, FINTRAC, expenditures; annual report; access to information; travel; hospitality; conferences
Federal

Main-track train derailment, Canadian Pacific Railway, Train 201-27, Mile 7.52, Leduc Subdivision, Blackfalds, Alberta, 27 September 2019

Last Updated: Feb. 28, 2022
Date Published: Aug. 16, 2021
Organization: Transportation Safety Board of Canada
Formats: HTML
Keywords:  safety investigation report
Federal

Main-track train derailment, Canadian National Railway Company, Freight train G86341-28, Mile 80.45, Vegreville Subdivision Chipman, Alberta, 29 September 2019

Last Updated: Feb. 28, 2022
Date Published: Mar. 31, 2021
Organization: Transportation Safety Board of Canada
Formats: HTML
Keywords:  safety investigation report
Federal

Uncontrolled movement of rolling stock, Canadian National Railway Company, Freight train L76951-10, Mile 0.5, Luscar Industrial Spur, Leyland, Alberta, 10 January 2018

Last Updated: Feb. 28, 2022
Date Published: Aug. 19, 2020
Organization: Transportation Safety Board of Canada
Formats: HTML
Keywords:  safety investigation report
Federal

This report presents the findings of the summative evaluation of the Space Technology Development Program (STDP) for the period of fiscal year 2002/03 to fiscal year 2007/08. The evaluation was undertaken to respond to a 2005 CSA internal audit that recommended that a review of STDP service delivery be undertaken. The Canadian Space Agency (CSA) engaged Government Consulting Services (GCS) to undertake the evaluation. The primary objective of the STDP is to develop and demonstrate strategic technologies and mission concepts that have a strong potential for having a positive impact on meeting the future needs of the Canadian Space Program and the growth of the Canadian space industry.

Last Updated: May 7, 2021
Date Published: Feb. 19, 2011
Organization: Canadian Space Agency
Formats: PDF/A-1
Keywords:  Canadian Space Agency, CSA, Evaluation, Internal Auditing, Program evaluation, Space Technology Development Program, STDP
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