News and Events

CDER Quality Management Maturity, August 2023 FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM)

New World Report is an insightful and informative business news platform providing readers throughout the Americas with business advice to aid business progress, success stories aimed to inspire and trends and innovations to support business growth and continuity. 

2022 FDA Digital Transformation SymposiumThe first annual digital transformation symposium hosted by the FDA’s Office of Digital Transformation

Data Modernization Action Plan (DMAP), proposes a framework and actionable recommendations for FDA’s Data Strategy. 

The FDA, United States and Health Canada co-hosting a public consultation on   2021

ICH Assembly virtual meeting, June 3th 2020. Future expansion of membership, progress on existing guidelines…. 

Quality by Design (QbD) with Biopharmaceuticals: Challenges and Solutions. April 29th, 2020 Online

Building a Quality Community in GTA. The quality improvement process is a lifetime journey that requires a supportive environment. 

MedDRA Management Committee, Amsterdam, the Netherlands, June 2019, The MedDRA Management Committee noted that 1 March 2019 marked the 20th anniversary of the first release of MedDRA. 

The FDA’s Technology Modernization Action Plan (TMAP). It describes important near-term actions that FDA is taking to…

ISO – BIOANALYTICAL METHOD VALIDATION
M10, Currently under public consultation, February 2019

Biomarker Qualification: Evidentiary Framework
Guidance for Industry and FDA Staff, December 2018

Data Integrity and Compliance With Drug CGMP Questions and Answers  Guidance for Industry Dec. 2018

Constantinus International Award 2018  – Canada wins three times This year the international CONSTANTINUS Award ceremony was hosted in Milan, Italy, where, for the eighth time, worldwide exemplary projects were honoured. 

World Standards Icons

World Standards Day 2018
Promotion of International Standard System

ISO 20700:2017 The main objective of this standard is to help clarify expectations between management consultants and their prospective clients, providing a platform for transparency and trust. 

ISO 17025:2017 General requirements for the competence of testing and calibration laboratories

Transforming Canada’s Innovation Economy
When small, medium-sized and large companies, academic institutions and not-for-profit [read more]

Canada’s Innovation and Skills Plan Budget 2017
Our country is uniquely placed to take advantage of the tremendous change that lies ahead. To do so, we will need to build the world’s most [read more]

ICH – M10 guideline, Oct 2016. This new guideline will apply to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. 

Canada became a standing regulatory member of ICH, Oct 2015 as a part of the reforms build on a 25-year successful delivery of harmonized guidelines.