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Medical Devices: a broad category for countless vital applications

12/6/2018 - Sophie Levecque, Qualified person GDP/GMP, QA and Medical Devices

Medical Devices literally play a vital role in society. As they are key for healing patients and saving lives, they are subject to ever-increasing standards….

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Challenges & opportunities in the Medical Devices landscape

12/6/2018 - Sophie Levecque, Qualified person GDP/GMP, QA and Medical Devices

Medical Devices are subject to increasing standards and regulations. Though this may be perceived as a nuisance sometimes, it’s certainly no unnecessary luxury. The past…

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Ensuring full data integrity, without any exceptions

23/5/2018 - Yves Dène, Lead Consultant CSV at Quality by Design

Data integrity is a cornerstone of scientific progress. However, a recent article in a leading Belgian newspaper shows that many researchers seem to tolerate violations…

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Updating Good Clinical Practice E6(R2)

15/5/2018 - Jonathan Boel, Pharmaceutical consultant & CSV Expert

Every day, patients around the world participate in clinical trials. Their contributions are crucial, as they ensure the progress of vital research. However, research involving…

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New Annex 1 draft of the EU GMP

13/2/2018 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

More than 10 years have passed since the last revision of Annex 1 of the EU GMP. On 20 December 2017, almost 3 years after…

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What are Good Distribution Practices?

19/12/2017 - Martijn Reniers, Managing Partner at Quality by Design

No need to ask Santa about GDP. Ask Sofie! GDP covers the crucial ‘last mile’ after production. It’s vital that patients receive their medication in…

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New steps by FDA & EU to eliminate double drug inspections

4/12/2017 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

The Mutual Recognition Agreement between the US and the European Union is gradually taking effect. Since November 2017 FDA recognizes the regulatory authorities of 8…

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QbD Software first to offer QMS as validated SaaS

22/11/2017 - Filip Heitbrink, CEO at QbD Software

CEO Filip Heitbrink presents world premiere Getting your Quality Management System up and running can be quite time- and budget- consuming. Platforms need to be…

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QbD competence centres: 4 levers to boost expertise

14/9/2017 - Martijn Reniers, Managing Partner at Quality by Design

Day by day our consultants rely on very specific expertise and experience to meet the varying challenges of their clients. That is why proactivity is…

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Digitalizing healthcare step by step

21/8/2017 - Filip Heitbrink, CEO at QbD Software

In a world that is becoming more digital each day, the healthcare environment is facing complex challenges. It’s clear that healthcare companies will need to…

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Preparing for growing challenges in pharmaceutical serialization

1/8/2017 - Vic Ampen, Serialization Expert and Pharmaceutical Product Engineer at Quality by Design

Serialization is rapidly emerging in the pharmaceutical world. To fight counterfeit drugs, more and more governments demand that every single sales product gets a unique…

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Echoes from a QbD training: the power of Lean

14/7/2017 - Katrien Janssens, Senior Consultant at QbD/ Training Manager

Specialised trainings are one way in which we keep investing in the expertise of our QbD team. Three QbD colleagues share their views on the…

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Ready for the new FDA and EU rules for medical devices?

13/7/2017 - Yves Dène, Lead Consultant CSV at Quality by Design

The rapid digital transformation drives a steady flow of new recommendations and rules. The industry must adapt and comply. What is the impact of the…

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Antleron & QbD team up to create a landslide in healthcare

11/5/2017 - Martijn Reniers, Managing Partner at Quality by Design

A whole new era in healthcare is coming closer every day. Thanks to the crossover of 3D printing and biology, medical solutions will be personalised…

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Data integrity in the pharma industry – a short introduction

14/12/2016 - Yves Dène, Lead Consultant CSV at Quality by Design

Over the last couple of years, the data integrity topic has received more and more attention. Recently, the American Food and Drug Administration (FDA) issued…

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Pharmacy and automation in Japan and Belgium – the differences

25/11/2016 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

As a pharmaceutical project engineer at QbD, every day is different.

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The bright future of the Belgian life sciences industry

4/10/2016 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

In the last three years, the life sciences industry has realized around 3,000 to 3,500 extra jobs in Belgium. This comes down to over 1,000…

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New breakthrough in negotiations around orphan drugs

23/6/2016 - Kristien Reekmans, Pharmaceutical Project Engineer

The latest developments in the market for orphan drugs are promising. In addition to the Netherlands and Luxembourg, the Flemish minister of public health Maggie…

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