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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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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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