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Belgium as pioneer in ATMPs: now and in the future

11/4/2019 - Jan Schrooten, co-founder and CEO at Antleron

Backed by increasing investments from commercial sponsors, the development of advanced therapy medicinal products (ATMPs) is growing strongly in the United Kingdom. For good reason,…

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Technical writing: the importance, do’s and don’ts

3/4/2019 - Frederik Schietekat, Pharmaceutical Consultant

Imagine explaining the use of Excel and all its functions to someone who has never worked with the program before – in a written manual….

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Process Validation as focal point for Competence Center Qualification & Validation

3/4/2019 - Bart Verlinden, Validation Engineer

The qualification and validation group within QbD organized their first Competence Center a few weeks ago. This forum is used to discuss interesting topics concerning…

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Market introduction of new medical devices: submit under MDD or MDR?

27/3/2019 - Steven Vinkx, Pharmaceutical Project Engineer

Countries rely on the use of medical devices to achieve universal health coverage, respond to health emergencies and keep populations safe. We see companies designing…

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A day in the life of … Imrane, Process Engineer

25/3/2019 - Imrane Boujtoh, Process Engineer

Wondering how a typical working day at Quality by Design looks like? In part 2 of our  ‘A day in the QbD life of’ blog…

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Sweating out the Monday blues

11/3/2019 - Elly De Bruyn, HR Manager at Quality by Design

How QbD puts the ‘play’ into ‘work, play, deliver’ – part 1 One upon a time, Martijn, one of QbD’s managing partners, had a brilliant…

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ATMPs in a nutshell: what you should know about classification, quality and go to market

6/3/2019 - Wim Steenackers Business Development Manager at Quality by design

Advanced therapy medicinal products (ATMPs) is the group of therapies in which we use cells, genes, engineered tissues and combinations of the above with medical…

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A day in the QbD life of… Henrik, QA compliance consultant

25/2/2019 - Stephanie Verwimp, Marketing & Communication Manager

Want to know what a typical working day at Quality by Design looks like? In part 1 of our brand new ‘A day in the…

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Serialization in the EU can become a competitive advantage if you dare to innovate

17/1/2019 - Yacine El Aroussi

Counterfeiting has always been a significant issue. While it might sound like a good deal when you can find your favorite brand of consumer good…

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EU GMP Annex I: Are we ready for the challenges posed after its revision?

11/1/2019 - Almudena Moya, Pharmaceutical Consultant

After months of revision and many questions raised, it now appears that the time is coming to implement the new requirements contained in the revision…

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Failing implant coordination: improvements to be made with new MDR regulation

2/12/2018 - Steven Vinkx, Pharmaceutical Project Engineer

These past few days, the European Union’s lack of medical device regulation has been highlighted by many news outlets. As a result, the Government faced…

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Our Health & 3D printing: a match made in heaven?

3/11/2018 - Charlotte De Vriendt, Pharmaceutical Consultant at QbD

In recent years, 3D printing techniques have been revolutionising the healthcare industry everywhere in the world. 3D printing has the ability to print personalised medical…

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Pioneering with Artificial Intelligence to make personalized cell therapy more accessible

29/8/2018 - Evan Claes, R&D Engineer at Antleron

Several scientific and clinical breakthroughs of our past decade show that Advanced Therapy Medicinal Products (ATMPs) will revolutionize 21st century medicine. By using cells as…

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A critical look at the new Annex 1 draft of the EU GMP

10/7/2018 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

On 20 December 2017, the European Medicines Agency (EMA) published the draft for the new Annex 1 “Manufacture of Sterile Medicinal Products”. At QbD, we…

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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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