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October 5, 2022Like

Tackling diversity in clinical trials

Health Canada has introduced a new questionnaire to track the inclusion of disaggregated data on sex, age, and race, in clinical trials. What is disaggregated data? Disaggregated data is the presentation of data broken into segments. For example, test results for marginalized groups versus the entire test population (i.e., the..... Read More
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July 7, 2022Like

Benefits of AI in Pharmacovigilance

Pharmacovigilance, commonly known as drug safety, is the process of collecting, detecting, assessing, monitoring, and preventing adverse events (AEs) associated with the use of medicinal products. Pharmacovigilance risk management involves many different activities, such as case intake and processing, causality assessment, narrative writing, regulatory submission of Individual Case Safety Reports..... Read More
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April 28, 2022Like

Thank you, Charlotte

Charlotte has an incredible breadth of experience in quality assurance and quality compliance. Since 2013, Charlotte has been a Senior Consultant and an integral part of the AXSource family. With over 20 years in QA Management, she has hosted and coordinated hundreds of successful inspections with regulatory agencies (drug product,..... Read More
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March 8, 2022Like

Real stories from real women #IWD2022

This year’s theme for International Women’s Day (IWD) is #BreakTheBias.  There is a detailed report on Women in the Workplace that LeanIn.Org and McKinsey & Company issues each year. It’s based on research from 423 companies in the United States & Canada. Participants are from the private, public, and social..... Read More
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December 23, 2021Like

Health Canada MDEL renewal for 2022

To maintain an active Medical Device Establishment Licence (MDEL) must apply to renew their licence before April 1 each year. The purpose of the Annual Licence Review (ALR) process is to ensure that MDEL holders continue to comply with the Canadian Medical Device Regulations, and to ensure licence information is..... Read More
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November 4, 2021Like

Have you heard of Good Machine Learning Practice (GMLP)?

Health Canada, the US Food & Drug Administration, and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) have collaborated to identify 10 guiding principles to govern the development of Good Machine Learning Practice (GMLP). Medical devices that use artificial intelligence (AI) and machine learning (ML) technologies are increasingly recognized..... Read More
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September 30, 20212

FDA enhances its KASA System for Drug Substance

What is KASA? KASA is an assessment tool that was designed to maximise the efficiency of the regulatory review process. The tool relies on structured data to eliminate some of the redundancies of more traditional assessment formats (narrative text and lengthy summaries). KASA stands for Knowledge-Aided Assessment and Structure Application..... Read More
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July 30, 20212

5 Common Hurdles with CSV

In today’s health product industry, software systems are commonly used in manufacturing, inventory control and Quality Management Systems (e.g., complaint handling, CAPA management, document control). Due to their impact on product quality compliance, regulatory agencies such as FDA, Health Canada and EMA, to name a few, require that computerized systems..... Read More
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June 17, 20212

Health Canada’s newest regulatory pathway is for products that don’t quite ‘fit’

Effective novel and complex medicines are emerging. As science and technology progresses towards increasingly complex and personalized medicines, regulators have recognized the need for a more agile approach to licensing and compliance. The current regulatory framework simply doesn’t work for a select group of very novel, very complex products. Need..... Read More
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June 7, 20212

An update on the new XML Product Monograph (XML PM)

Product Monographs are used to provide information about the appropriate use of a drug to physicians, pharmacists, nurses, healthcare professionals, and consumers. Health Canada aims to harmonize the structure of Product Monographs and convert them into a structured format called the XML Product Monograph (XML PM) as a part of..... Read More