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Benefits of AI in Pharmacovigilance 1
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
Thank you, Charlotte 3
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
Real stories from real women #IWD2022 5
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
Health Canada MDEL renewal for 2022 9
December 22, 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
Have you heard of Good Machine Learning Practice (GMLP)? 11
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
FDA enhances its KASA System for Drug Substance 13
September 30, 20211

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
5 Common Hurdles with CSV 17
July 30, 20211

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............ Read More
Health Canada’s newest regulatory pathway is for products that don’t quite ‘fit’ 19
June 17, 20211

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
An update on the new Structured Product Monograph (SPM) 21
June 7, 20211

An update on the new Structured Product Monograph (SPM)

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 Structured Product Monograph (SPM) as a part of a regulatory............ Read More
Tips on conducting clinical trials during the pandemic. 23
May 28, 20211

Tips on conducting clinical trials during the pandemic.

As always, ensure patient safety remains the top priority. The COVID-19 pandemic has impacted the health risks associated with running ongoing clinical trials. As a result, Sponsors must take the initiative to implement measures to reduce or prevent the risk of becoming infected with COVID-19. One should consider the availability............ Read More
Benefits of AI in Pharmacovigilance 25
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
Thank you, Charlotte 27
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
Real stories from real women #IWD2022 29
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
Health Canada MDEL renewal for 2022 33
December 22, 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
Have you heard of Good Machine Learning Practice (GMLP)? 35
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
FDA enhances its KASA System for Drug Substance 37
September 30, 20211

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
5 Common Hurdles with CSV 41
July 30, 20211

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............ Read More
Health Canada’s newest regulatory pathway is for products that don’t quite ‘fit’ 43
June 17, 20211

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
An update on the new Structured Product Monograph (SPM) 45
June 7, 20211

An update on the new Structured Product Monograph (SPM)

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 Structured Product Monograph (SPM) as a part of a regulatory............ Read More
Tips on conducting clinical trials during the pandemic. 47
May 28, 20211

Tips on conducting clinical trials during the pandemic.

As always, ensure patient safety remains the top priority. The COVID-19 pandemic has impacted the health risks associated with running ongoing clinical trials. As a result, Sponsors must take the initiative to implement measures to reduce or prevent the risk of becoming infected with COVID-19. One should consider the availability............ Read More
Retail_hero_blog
March 31, 20211

Announcing Microsoft Cloud for Retail: Built for what’s next

2020 was the year in which we experienced disruptive change at a pace and a scale that we could never have imagined. Yet it was also the year in which many retailers embraced digital like never before. Take REI for example, which launched a new virtual outfitting service to help............ Read More
Adapt quickly and fulfill efficiently with Dynamics 365 Intelligent Order Management 49
March 31, 20211

Adapt quickly and fulfill efficiently with Dynamics 365 Intelligent Order Management

Digital commerce is reshaping every step in the supply chain.  Consumers today expect seamless omnichannel buying and after-purchase experiences with multiple fast delivery options.   Many organizations, however, are struggling to modernize operations to keep up with the growth. In fact, a recent study* found that nearly 61 percent1 of companies............ Read More
new
February 25, 20211

3 Reasons to Accelerate Your Migration to Dynamics 365

Having spoken to over 300 Microsoft Dynamics 365 on-premises customers, I have a lot of empathy for companies that are faced with the decision to migrate to the cloud. Most commonly I’ve heard that changing business software can appear risky, daunting, and expensive, but the customers that have successfully migrated............ Read More
Resilient Supply Chain - Warehouse worker a
February 25, 20211

Quickly Respond to Changing Retail Needs With an Intelligent Supply Chain

Truly engaged, always connected As digital commerce continues to evolve and become an integral revenue stream for retailers and consumer goods companies, it is paramount for these companies to digitally transform their supply chain as well. They need the agility to rapidly plan and adapt to changing customer needs, use............ Read More
Enable a New Level of B2B Digital Sales Excellence with Dynamics 365 Commerce 50
January 29, 20212

Enable a New Level of B2B Digital Sales Excellence with Dynamics 365 Commerce

Truly engaged, always connected At this year’s NRF, many retailers are taking the time to reflect on the learnings from 2020 and the road ahead for 2021. It’s hard to believe that only 12 months have passed since we disclosed the general availability of Microsoft Dynamics 365 Commerce, which was............ Read More
Increase Visibility Into Inventory Across Your Supply Chain 51
January 29, 20211

Increase Visibility Into Inventory Across Your Supply Chain

To run an effective manufacturing and distribution operation, you need an accurate understanding of your inventory and where it’s located along the supply chain. What’s more, having clear visibility into your inventory has become critically important as organizations shift to omnichannel order fulfillment and distribution and therefore need to manage............ Read More
Create a Resilient Organization
November 13, 20203

Create a Resilient Organization For Now and the Future

While COVID-19 rapidly changes the way we live and work, organizations all over the world are facing daunting challenges. Businesses are undergoing significant internal changes to accommodate newly remote workforces while reacting to seismic shifts in customer needs and behaviors. As the Microsoft Business Applications team adapts to the crisis,............ Read More
blog image - D365 - power platforms
November 6, 20202

Tallying the momentous growth and continued expansion of Dynamics 365 and the Power Platform

We’ve seen incredible growth of Dynamics 365 and the Power Platform just in the past year. This momentum is driving a massive investment in people and breakthrough technologies that will empower organizations to transform in the next decade. We have allocated hundreds of millions of dollars in our business cloud............ Read More
Why_Use_Dynamics365_Project_Service_Automation_1600x464
April 8, 20202

Let Me Introduce You to — Your 21st Century B2B Customer

New technologies and the generational change have led to a blur between the expectations of B2C and B2B customers. This presents new challenges for many companies that have come to terms with the fact that B2B customers think differently to B2C customers. It suddenly seems as if the differentiation between B2C............ Read More
Who_Benefits_CRM_One_740x417
April 8, 20201

How to Capture B2B Customer Feedback to Improve Your B2B E-Commerce Experience

In B2B e-commerce, you often have a closer relationship with your customers than in B2C. You tend to have regular contact with your B2B customers, and they are generally much more loyal to your company. You know their name, address and phone number; you might even know their birthday, personal............ Read More