---
title: Blog (17)
description: Stay updated on Life Science through expert insights, industry trends, latest news and more with PQE Group's blog. (17)
---

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# **Latest Insights**

[Clinical Research ![](https://blog.pqegroup.com/hubfs/Recommendation%20on%20decentralized%20elements%20in%20clinical%20trials_Site%20Banner.jpg)](https://blog.pqegroup.com/clinical-studies/recommendation-decentralized-elements-clinical-trials)

25 Jul 2023

## [Recommendation on decentralized elements in clinical trials The EU Commission released a recommendation paper on decentralized elements in clinical trials in late 2022. The document addresses the increasing...](https://blog.pqegroup.com/clinical-studies/recommendation-decentralized-elements-clinical-trials)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/clinical-studies/recommendation-decentralized-elements-clinical-trials&title=Recommendation%20on%20decentralized%20elements%20in%20clinical%20trials&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Recommendation%20on%20decentralized%20elements%20in%20clinical%20trials_Site%20Banner.jpg&description=The%20EU%20Commission%20released%20a%20recommendation%20paper%20on%20decentralized%20elements%20in%20clinical%20trials%20in%20late%202022.%20The%20document%20addresses%20the%20increasing...> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/clinical-studies/recommendation-decentralized-elements-clinical-trials&title=Recommendation%20on%20decentralized%20elements%20in%20clinical%20trials&summary=The%20EU%20Commission%20released%20a%20recommendation%20paper%20on%20decentralized%20elements%20in%20clinical%20trials%20in%20late%202022.%20The%20document%20addresses%20the%20increasing...> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Recommendation%20on%20decentralized%20elements%20in%20clinical%20trials&url=https://blog.pqegroup.com/clinical-studies/recommendation-decentralized-elements-clinical-trials)

[Engineering ![](https://blog.pqegroup.com/hubfs/Contamination%20Control%20Strategy_Techniconsult_SIte%20Banner.jpg)](https://blog.pqegroup.com/engineering/contamination-control-strategy-in-annex-1)

18 Jul 2023

## [The importance of the contamination control strategy (CCS) in relation to Annex 1 The CCS concept permeates the entire Annex 1 document and is a fundamental principle. It indicates examples and topics that need to be addressed.](https://blog.pqegroup.com/engineering/contamination-control-strategy-in-annex-1)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/engineering/contamination-control-strategy-in-annex-1&title=The%20importance%20of%20the%20contamination%20control%20strategy%20(CCS)%20in%20relation%20to%20Annex%201&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Contamination%20Control%20Strategy_Techniconsult_SIte%20Banner.jpg&description=The%20CCS%20concept%20permeates%20the%20entire%20Annex%201%20document%20and%20is%20a%20fundamental%20principle.%20It%20indicates%20examples%20and%20topics%20that%20need%20to%20be%20addressed.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/engineering/contamination-control-strategy-in-annex-1&title=The%20importance%20of%20the%20contamination%20control%20strategy%20(CCS)%20in%20relation%20to%20Annex%201&summary=The%20CCS%20concept%20permeates%20the%20entire%20Annex%201%20document%20and%20is%20a%20fundamental%20principle.%20It%20indicates%20examples%20and%20topics%20that%20need%20to%20be%20addressed.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=The%20importance%20of%20the%20contamination%20control%20strategy%20(CCS)%20in%20relation%20to%20Annex%201&url=https://blog.pqegroup.com/engineering/contamination-control-strategy-in-annex-1)

[Pharmacovigilance ![](https://blog.pqegroup.com/hubfs/Vet%20Questions_3.jpg)](https://blog.pqegroup.com/ra-phv/quality-management-system-supporting-pharmacovigilance-processes-activities-inspection)

14 Jul 2023

## [Is your Quality Management System effective in supporting the pharmacovigilance processes and activities? Are you ready for your next inspection? Market Authorization Holders are now mandated to undergo the QMS to ensure compliance with the newly implemented laws of the VGVP.](https://blog.pqegroup.com/ra-phv/quality-management-system-supporting-pharmacovigilance-processes-activities-inspection)

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[Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/EMA%20Medicine%20Shortage%20Prevention_Site%20Banner.jpg)](https://blog.pqegroup.com/ra-phv/medicinal-product-shortages-compliance-with-ema-guideline-on-good-practice)

12 Jul 2023

## [Prevention and management of human medicinal product shortages in compliance with the recent EMA guideline on good practices for industry 2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.](https://blog.pqegroup.com/ra-phv/medicinal-product-shortages-compliance-with-ema-guideline-on-good-practice)

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[Quality by Design ![](https://blog.pqegroup.com/hubfs/AI%20Act_Site%20Banner.jpg)](https://blog.pqegroup.com/quality-by-design/pqe-group-on-eu-ai-act)

11 Jul 2023

## [PQE Group view on the EU AI Act The EU is the first to try to finally regulate AI as part of its digital strategy. The EU AI Act should pass into law in early 2024.](https://blog.pqegroup.com/quality-by-design/pqe-group-on-eu-ai-act)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/quality-by-design/pqe-group-on-eu-ai-act&title=PQE%20Group%20view%20on%20the%20EU%20AI%20Act&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/AI%20Act_Site%20Banner.jpg&description=The%20EU%20is%20the%20first%20to%20try%20to%20finally%20regulate%20AI%20as%20part%20of%20its%20digital%20strategy.%20The%20EU%20AI%20Act%20should%20pass%20into%20law%20in%20early%202024.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/quality-by-design/pqe-group-on-eu-ai-act&title=PQE%20Group%20view%20on%20the%20EU%20AI%20Act&summary=The%20EU%20is%20the%20first%20to%20try%20to%20finally%20regulate%20AI%20as%20part%20of%20its%20digital%20strategy.%20The%20EU%20AI%20Act%20should%20pass%20into%20law%20in%20early%202024.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=PQE%20Group%20view%20on%20the%20EU%20AI%20Act&url=https://blog.pqegroup.com/quality-by-design/pqe-group-on-eu-ai-act)

[Medical Device ![](https://blog.pqegroup.com/hubfs/Medical%20Device%20Software_FDA_Site%20Banner.jpg)](https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software)

11 Jul 2023

## [New FDA guidance on premarket submission for software: what happens now? New FDA's guidance providing updates on the documentation recommended for inclusion in premarket submissions for its review of device software.](https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software&title=New%20FDA%20guidance%20on%20premarket%20submission%20for%20software:%20what%20happens%20now?&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Medical%20Device%20Software_FDA_Site%20Banner.jpg&description=New%20FDA's%20guidance%20providing%20updates%20on%20the%20documentation%20recommended%20for%20inclusion%20in%20premarket%20submissions%20for%20its%20review%20of%20device%20software%20functions. > <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software&title=New%20FDA%20guidance%20on%20premarket%20submission%20for%20software:%20what%20happens%20now?&summary=New%20FDA's%20guidance%20providing%20updates%20on%20the%20documentation%20recommended%20for%20inclusion%20in%20premarket%20submissions%20for%20its%20review%20of%20device%20software%20functions. > [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=New%20FDA%20guidance%20on%20premarket%20submission%20for%20software:%20what%20happens%20now?&url=https://blog.pqegroup.com/medical-device/new-fda-guidance-premarket-submission-for-software)

[Commissioning, Qualification and Validation (CQV) ![](https://blog.pqegroup.com/hubfs/Glove%20Test_Site%20Banner.jpg)](https://blog.pqegroup.com/commissioning-qualification/3w-glove-integrity-test)

10 Jul 2023

## [3W of Glove Integrity Test Why is it important to test glove integrity in isolators or rabs and when should it be done? What norms and regulations apply to glove integrity.](https://blog.pqegroup.com/commissioning-qualification/3w-glove-integrity-test)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/commissioning-qualification/3w-glove-integrity-test&title=3W%20of%20Glove%20Integrity%20Test&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Glove%20Test_Site%20Banner.jpg&description=Why%20is%20it%20important%20to%20test%20glove%20integrity%20in%20isolators%20or%20rabs%20and%20when%20should%20it%20be%20done?%20What%20norms%20and%20regulations%20apply%20to%20glove%20integrity%20testing> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/commissioning-qualification/3w-glove-integrity-test&title=3W%20of%20Glove%20Integrity%20Test&summary=Why%20is%20it%20important%20to%20test%20glove%20integrity%20in%20isolators%20or%20rabs%20and%20when%20should%20it%20be%20done?%20What%20norms%20and%20regulations%20apply%20to%20glove%20integrity%20testing> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=3W%20of%20Glove%20Integrity%20Test&url=https://blog.pqegroup.com/commissioning-qualification/3w-glove-integrity-test)

[Medical Cannabis ![](https://blog.pqegroup.com/hubfs/Chemotypes%20of%20Cannabis_Site_PQE-1.jpg)](https://blog.pqegroup.com/medical-cannabis/chemotypes-of-cannabis)

07 Jul 2023

## [Chemotypes of cannabis (1/4) Cannabis sativa is a dioecious plant that is widely distributed in areas with a temperate climate. The plant has three main varieties, each with its.](https://blog.pqegroup.com/medical-cannabis/chemotypes-of-cannabis)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-cannabis/chemotypes-of-cannabis&title=Chemotypes%20of%20cannabis%20(1/4)&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Chemotypes%20of%20Cannabis_Site_PQE-1.jpg&description=Cannabis%20sativa%20is%20a%20dioecious%20plant%20that%20is%20widely%20distributed%20in%20areas%20with%20a%20temperate%20climate.%20The%20plant%20has%20three%20main%20varieties,%20each%20with%20its%20own...> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-cannabis/chemotypes-of-cannabis&title=Chemotypes%20of%20cannabis%20(1/4)&summary=Cannabis%20sativa%20is%20a%20dioecious%20plant%20that%20is%20widely%20distributed%20in%20areas%20with%20a%20temperate%20climate.%20The%20plant%20has%20three%20main%20varieties,%20each%20with%20its%20own...> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Chemotypes%20of%20cannabis%20(1/4)&url=https://blog.pqegroup.com/medical-cannabis/chemotypes-of-cannabis)

[Laboratory ![](https://blog.pqegroup.com/hubfs/Electronic%20Data%20Laboratory%20Management_Site%20Banner.jpg)](https://blog.pqegroup.com/laboratory/optimization-electronic-data-laboratory-management)

04 Jul 2023

## [Electronic Data Laboratory Management: which is the best way to optimize the process? Explore the benefits and considerations of implementing an Electronic Laboratory Notebook (ELN) to enhance laboratory data management.](https://blog.pqegroup.com/laboratory/optimization-electronic-data-laboratory-management)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/laboratory/optimization-electronic-data-laboratory-management&title=Electronic%20Data%20Laboratory%20Management:%20which%20is%20the%20best%20way%20to%20optimize%20the%20process?&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Electronic%20Data%20Laboratory%20Management_Site%20Banner.jpg&description=Explore%20the%20benefits%20and%20considerations%20of%20implementing%20an%20Electronic%20Laboratory%20Notebook%20(ELN)%20to%20enhance%20laboratory%20data%20management.> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/laboratory/optimization-electronic-data-laboratory-management&title=Electronic%20Data%20Laboratory%20Management:%20which%20is%20the%20best%20way%20to%20optimize%20the%20process?&summary=Explore%20the%20benefits%20and%20considerations%20of%20implementing%20an%20Electronic%20Laboratory%20Notebook%20(ELN)%20to%20enhance%20laboratory%20data%20management.> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Electronic%20Data%20Laboratory%20Management:%20which%20is%20the%20best%20way%20to%20optimize%20the%20process?&url=https://blog.pqegroup.com/laboratory/optimization-electronic-data-laboratory-management)

[Medical Device ![](https://blog.pqegroup.com/hubfs/Medical%20Device%20Regulations%20EU%20vs%20USA_Site%20Banner%20(1).jpg)](https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda)

30 Jun 2023

## [Medical Device Regulations in the EU (MDR) vs. FDA (US Food and Drug Administration) Challenges and Considerations in Launching a Medical Device in Multiple Markets. A comparison between EU (MDR) vs. FDA (US Food and Drug.](https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda)

<https://www.facebook.com/sharer/sharer.php?u=https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda&title=Medical%20Device%20Regulations%20in%20the%20EU%20(MDR)%20vs.%20FDA%20(US%20Food%20and%20Drug%20Administration)&picture=https://19575960.fs1.hubspotusercontent-na1.net/hubfs/19575960/Medical%20Device%20Regulations%20EU%20vs%20USA_Site%20Banner%20%281%29.jpg&description=Challenges%20and%20Considerations%20in%20Launching%20a%20Medical%20Device%20in%20Multiple%20Markets.%20A%20comparison%20between%20EU%20(MDR)%20vs.%20FDA%20(US%20Food%20and%20Drug%20Administration)> <http://www.linkedin.com/shareArticle?mini=true&url=https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda&title=Medical%20Device%20Regulations%20in%20the%20EU%20(MDR)%20vs.%20FDA%20(US%20Food%20and%20Drug%20Administration)&summary=Challenges%20and%20Considerations%20in%20Launching%20a%20Medical%20Device%20in%20Multiple%20Markets.%20A%20comparison%20between%20EU%20(MDR)%20vs.%20FDA%20(US%20Food%20and%20Drug%20Administration)> [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Medical%20Device%20Regulations%20in%20the%20EU%20(MDR)%20vs.%20FDA%20(US%20Food%20and%20Drug%20Administration)&url=https://blog.pqegroup.com/medical-device/medical-device-regulations-eu-mdr-vs-fda)

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### Categories

- [Annex 1 (14)](https://blog.pqegroup.com/tag/annex-1)
- [Artificial Intelligence (10)](https://blog.pqegroup.com/tag/artificial-intelligence)
- [Audits (3)](https://blog.pqegroup.com/tag/audits)
- [Clinical Research (8)](https://blog.pqegroup.com/tag/clinical-research)
- [Commissioning, Qualification and Validation (CQV) (11)](https://blog.pqegroup.com/tag/commissioning-qualification-and-validation-cqv)
- [CSV & Data Integrity (20)](https://blog.pqegroup.com/tag/csv-data-integrity)
- [Cybersecurity (19)](https://blog.pqegroup.com/tag/cybersecurity)
- [Engineering (13)](https://blog.pqegroup.com/tag/engineering)
- [FemTech (13)](https://blog.pqegroup.com/tag/femtech)
- [GxP Compliance (49)](https://blog.pqegroup.com/tag/gxp-compliance)
- [IT Operations (6)](https://blog.pqegroup.com/tag/it-operations)
- [Laboratory (3)](https://blog.pqegroup.com/tag/laboratory)
- [Medical Cannabis (44)](https://blog.pqegroup.com/tag/medical-cannabis)
- [Medical Device (20)](https://blog.pqegroup.com/tag/medical-device)
- [Next Generation Products (4)](https://blog.pqegroup.com/tag/next-generation-products)
- [Pharmacovigilance (12)](https://blog.pqegroup.com/tag/pharmacovigilance)
- [Quality by Design (4)](https://blog.pqegroup.com/tag/quality-by-design)
- [Regulatory Affairs (26)](https://blog.pqegroup.com/tag/regulatory-affairs)
- [Startup (2)](https://blog.pqegroup.com/tag/startup)
- [Training (1)](https://blog.pqegroup.com/tag/training)
- [Veterinary (2)](https://blog.pqegroup.com/tag/veterinary)

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