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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)
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.
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.
Main-track derailment, Canadian National Railway Company, Freight train G83342-24, Mile 24.30, Wainwright Subdivision, Landis, Saskatchewan, 26 September 2018
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
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
Main-track train derailment, Canadian Pacific Railway, Train 201-27, Mile 7.52, Leduc Subdivision, Blackfalds, Alberta, 27 September 2019
Main-track train derailment, Canadian National Railway Company, Freight train G86341-28, Mile 80.45, Vegreville Subdivision Chipman, Alberta, 29 September 2019
Uncontrolled movement of rolling stock, Canadian National Railway Company, Freight train L76951-10, Mile 0.5, Luscar Industrial Spur, Leyland, Alberta, 10 January 2018
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.