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What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?
Discover why usability testing is essential for compliance and safety in Near-Patient and self-testing devices under the IVDR. Learn key guidelines, study designs, and tips for successful usability evaluations.
The Essential Elements of Life Science SEO Marketing
Master the art of life science SEO marketing to elevate your online presence. This article explores essential strategies like content creation, keyword research, and website optimization, tailored to help life science companies achieve higher rankings, attract targeted leads, and drive sustainable growth in a competitive digital landscape.
When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?
Compliance with Annex XIV is essential for certain IVD performance studies under the IVDR, such as those involving surgically invasive sampling or interventional procedures. Learn when these requirements apply, what documentation is needed, and how to navigate the regulatory process effectively to ensure ethical standards, participant safety, and timely market access.
5 Key Toxicological Monitoring Tests for Regulatory Compliance
Explore essential toxicological monitoring tests, including E&L, Nitrosamine Analysis, and Ames Test, to ensure safety and meet regulatory standards.
What are the requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?
The introduction of the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has reshaped how in vitro diagnostic (IVD) devices are regulated in Europe. With a stronger focus on clinical evidence and performance evaluation, clinical performance studies are now crucial for proving an IVD device’s safety and effectiveness.
Let’s explore the key requirements for conducting these studies, focusing on compliance with IVDR and EN ISO 20916:2024.
Pharmacovigilance (PV) Safety Databases: Why They Matter and How to Choose the Right One
Learn the key functions of PV safety databases, why they are crucial for patient safety and compliance, and how to choose the right one for your organization.
How to define your Clinical Performance Strategy?
Defining a clinical performance strategy for an in vitro diagnostic (IVD) device requires a structured approach. A solid strategy helps you stay focused and make realistic estimates around timelines and budgets. Discover the key components you’ll want to consider when defining your strategy.
Understanding REACH Registration for Chemicals in Pharma
REACH registration is more than just a regulatory box to check — it’s a crucial step for companies in the pharma, life sciences, and chemical industries manufacturing or importing substances into the EU.
This blog post walks you through what REACH entails, why it matters, and how to ensure smooth compliance with all requirements relevant to these fields.
Why is Clinical Performance key to a successful IVDR submission?
Did you know that the IVDR mandates robust clinical evidence to support the validity and performance of IVD assays? In this article we’ll explore the role of Clinical Performance in a smooth IVDR submission.
Sterilization Validation: A Practical Guide to Ensuring Safety and Compliance
Ensure product safety with effective sterilization validation. Learn key steps, methods, and challenges to meet regulatory standards in healthcare and pharma.
15 Years of ATMPs – Reflecting on the Past, Shaping the Future
Advanced Therapy Medicinal Products (ATMPs) have revolutionized medicine, offering new treatments for once untreatable conditions. The recent CAT Scientific Symposium celebrated 27 approved ATMPs, addressing everything from rare genetic disorders to advanced cancers. Read the full article to discover how CAT’s efforts have shaped the evolution of ATMPs.
Maintaining Validation Excellence: Continuous Improvement Through Periodic Validation Reviews in Pharma
Learn how periodic validation reviews maintain pharma system compliance, using risk-based analysis and real-time monitoring to ensure continuous improvement
Technovigilance in Action: Safeguarding Health with Post-Market Surveillance of Medical Devices
Learn how technovigilance ensures medical device safety through post-market surveillance, tackling risks, compliance, and best practices.
Why Combining Scripted and Unscripted Testing Boosts Your CSV Strategy
Discover how combining unscripted and scripted testing ensures robust Computer System Validation (CSV) for compliance, accuracy, and system reliability.
The Rise of Knowledge Process Outsourcing in Drug Safety: Smarter Outsourcing for Safer Healthcare
Discover how strategic knowledge process outsourcing (KPO) is revolutionizing pharmaceutical drug safety departments, driving efficiency and innovation.
Stay Ahead of Compliance: How to Effectively Manage Your Yearly Audits
Manage yearly audits to ensure compliance and quality in pharma and medical devices. Learn key strategies and boost your QMS now!
Mastering EU Product Information: The Role of the EMA’s Linguistic Review Process in Centralised Procedures
Explore essential insights into the EMA Linguistic Review process for Product Information of medicinal products approved via the Centralised Procedure.
Accurate but appealing: How our scientific copywriters and designers collaborate to create captivating content
Effective communication can be the key to unlocking your company’s full communication potential, and that’s where skilled science writers come in, bridging the gap between complex research and clear, compelling narratives that drive engagement and growth.
Outsourcing Internal Audits: Benefits and Process Optimization in Your Pharma Company
Discover how outsourcing internal audits in your pharma company can boost compliance, optimize resources, and provide fresh, unbiased insights for continuous improvement.
Why scientists turn to communication: unlocking benefits for Life Sciences companies
Effective communication can be the key to unlocking your company’s full communication potential, and that’s where skilled science writers come in, bridging the gap between complex research and clear, compelling narratives that drive engagement and growth. At QbD Business & Communication our copy team are also scientists, but none of us are in the lab anymore. So, what happened?
The Risk of Benzene Contamination in Drug Products: What Manufacturers Need to Know
Learn about the risks of benzene contamination in pharmaceuticals, regulatory guidelines, and best practices for ensuring drug safety and quality in manufacturing.
Friability and Disintegration for Oral Solid Dose Forms: The Forgotten Tests
Discover the crucial role of friability and disintegration tests in ensuring the quality, safety, and effectiveness of pharmaceutical tablets.
Toxicological Assessment of Extractables and Leachables (E&L)
Learn about Extractables and Leachables in pharmaceuticals, including regulatory guidelines, analytical techniques, and safety assessments.
Analysing MHRA Performance: Clinical Trial and Amendment Applications in the UK
Gain an insightful understanding regarding the current review timelines for clinical trial and amendment applications of the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
Article 31 Referrals in Pharmacovigilance: A Brief Overview
Learn about the EMA’s Article 31 referral procedure for assessing medicine safety and resolving concerns in the EU.
How to Assess and Improve the Readability of Medicines: A Complete Guide
In the world of medicine, drug readability is a fundamental aspect to ensure safety and patient understanding. The purpose of the consultations is to ensure the proper interpretation of the package leaflet by the patients or users to whom the medicinal product is intended. However, it is worrying to note that many of the package inserts and drug labels are so complex that it is difficult for most people to understand them. In this blog, we will explore the importance of assessing the readability of human medicines and the methods used to measure it.
The Journey from Science to Story
Learn how to transform scientific breakthroughs into compelling stories. Discover strategies to effectively communicate your research to diverse audiences with QbD.
Analytical Method Transfer: Common Pitfalls and How to Avoid Them
Discover common pitfalls in analytical method transfers and learn strategies to avoid them for seamless drug development and manufacturing processes.
Elevate Pharma Imports with EU GMP Annexes 16 and 21
Discover how EU GMP Annexes 16 and 21 enhance pharmaceutical import quality and safety. Learn about their global impact on public health.
The Holy Grail: Achieving Inspection Readiness
Achieving inspection readiness ensures you’re always prepared for regulatory inspections. Learn the steps to stay compliant and confident every day.
Implementing PIC/S Standards in Hospital Cleanrooms: From Regulation to Application
Learn how to implement PIC/S standards in hospital cleanrooms by 2026 to ensure quality, safety, and compliance in pharmaceutical preparations.
The Role of Artificial Intelligence (AI) in Pharmacovigilance in Europe: Advances and Legislation
Explore AI’s transformative role in pharmacovigilance in Europe, enhancing drug safety and compliance with EMA regulations through advanced AI tools and legislation.
Curb Your Enthusiasm – How to Avoid Rushing into Your Business Development Efforts with Unexpected Cost Consequences
Learn how to strategically plan your business development efforts to avoid unexpected costs and ensure a successful product launch.
Social Media in Pharmacovigilance: Harnessing Online Conversations for Drug Safety
Explore how social media aids real-time drug safety monitoring and the challenges it presents in pharmacovigilance.
In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU
Discover the latest on EU regulations for In-House Devices (IHDs) under IVDR, ISO 15189:2022 updates, and MDCG 2023-1 guidance. Ensure compliance and patient safety.
Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights
Learn about nitrosamine impurities in medicinal products, their causes, regulatory guidance, and strategies for risk evaluation and mitigation.
What to expect when being inspected?
Ever wonder what happens during a regulatory inspection? Let’s dive into what to expect, from the inspector’s arrival to the post-inspection. Learn how to prepare for a smooth inspection and avoid unnecessary anxiety.
Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?
IVD manufacturers must align ISO 13485 and IVDR for a compliant Quality Management System. This article explores key considerations for harmonizing these frameworks.
SCADA Automation in Pharma: Boosting Efficiency and Compliance
Learn how SCADA automation systems revolutionize efficiency and ensure regulatory compliance in pharmaceutical manufacturing.
Post-Market Success under IVDR: Prioritizing PMS & PMPF
As the IVD industry undergoes significant regulatory changes with the implementation of Regulation (EU) 2017/746 (IVDR), manufacturers are facing new challenges and requirements regarding post-market surveillance (PMS) and post-market performance follow-up (PMPF). In this article, we explore the importance of prioritizing PMS and PMPF under the framework of the IVDR.
Impact of PDE Values on Cleaning Validation Design in Pharmaceutical Manufacturing
Explore how PDE values impact cleaning validation in pharmaceuticals, ensuring safety and compliance with industry standards.
Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)
Explore the risks of elemental impurities in drugs and how the ICH Q3D guideline helps ensure product safety and compliance.
The Crucial Role of Clinical Evidence in IVDR Compliance
This article explores the importance of clinical evidence for In Vitro Diagnostic Medical Devices (IVDs) under the new European Union Regulation (EU) 2017/746 (IVDR), and the challenges manufacturers face in meeting these new requirements.
Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance
Inspection readiness tips: Learn how to manage fallout and improve with CAPA for better regulatory compliance.
Why start building IVDR-compliant Technical Documentation now?
Even with the European Commission’s proposal for extending the transitional period for IVDs, manufacturers should start building compliant Technical Documentation now. This article highlights the importance of proactive action despite the proposed delay.
Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment
Explore how Environmental Risk Assessment (ERA) helps ensure medicines heal us without harming the planet, balancing healthcare advances with ecological preservation.
Understanding the European Commission’s proposal for extending the transitional period for IVDs
The European Commission proposes extending the deadlines for complying with the new In Vitro Diagnostic Medical Devices Regulation (IVDR). This article explores the reasons behind the extension and what it means for manufacturers.
Drug-Device Combination Products and Article 117: How to Stay Compliant?
Discover how to navigate compliance with Article 117 of MDR for drug-device combinations. Ensure correct implementation with essential guidance.
Patient Support Programs: Enhancing Patient Care through Pharmacovigilance
Discover how Patient Support Programs (PSPs) and Pharmacovigilance enhance patient care, ensuring safety and compliance throughout the healthcare journey.
FDA’s QMSR Introduction: Aligning Device CGMP Regulations with ISO 13485:2016
Explore the FDA’s final rule integrating ISO 13485:2016 into QMSR for medical devices. Understand impacts on manufacturers and how to comply by 2026.
IVDR Transitional Extension: Why full speed ahead is still the best strategy
This article explores why staying on track for IVDR compliance is still the best strategy for medical device manufacturers.
Declaration of Equivalence for Medical Devices under the MDR
Discover what is required to declare equivalence under the MDR for medical devices in the EU.
A Deeper Dive into the MHRA Good Pharmacovigilance Practice (GPvP) Inspection Metrics and Findings
Gain an insightful understanding into how the MHRA inspect the Pharmacovigilance services of an MAH for post-authorised products.
Impact of the AI Act on the MedTech and Life Sciences Industry
Explore how the AI Act impacts MedTech and Life Sciences, and how the QbD Group can guide you through its complexities.
The Impact of EU IVDR on Clinical Trials
We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Bogaert and Anne Paulussen, recently featured in RAPS
MHRA to Launch RegulatoryConnect Portal in the UK: A New Era in Regulatory Management
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently announced the upcoming launch of the RegulatoryConnect portal, a groundbreaking step forward in regulatory management. During
ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline
The new ICH Q2(R2) is a complete revision of the guideline to include more recent application of analytical procedures and to align content with ICH Q14 “Analytical Procedure Development”.
Exploring the U.S. Regulatory Framework for Mobile Health
The United States maintains a robust regulatory foundation for Digital Therapeutics (DTx), ensuring that they are supported by stringent regulatory measures, including clinical evidence and data protection management. Learn more here.
How to create a GMP-Compliant Stability Protocol?
Discover how to create a GMP-compliant stability protocol for pharmaceuticals, ensuring product safety and efficacy throughout its shelf life.
Digital Therapeutics in the UK: The Post-Brexit Landscape
In this blog post, we delve into the intricacies of Digital Therapeutics (DTx) regulation in the UK, especially in light of Brexit in January 2020.
We Celebrate “International Women’s Day” by Putting the Spotlight on the QbD Group’s Power Ladies
In celebration of International Women’s Day, with ‘Inspire Inclusion’ as the central theme for 2024, we sat down with some of QbD Group’s power ladies.
How to avoid non-compliance in the pharmaceutical industry
This blog underscores the critical nature of regulatory compliance in the pharmaceutical industry. It stresses the importance of senior management’s commitment despite significant costs. Key elements like Corrective Action Preventive Action (CAPA) plans are highlighted, especially with the trend towards computerized solutions. Non-compliance risks severe financial consequences, necessitating proactive measures. Effective compliance programs encompass written procedures, designated personnel, training, communication, and monitoring. Compliance is increasingly seen as a strategic advantage rather than just a cost-saving measure.
Toxicology Challenges in Pharma: How to Address Them?
Explore how to tackle current and upcoming toxicology challenges in the pharmaceutical industry, ensuring product safety and environmental responsibility.
The DTx Landscape in Belgium, France, and Their Inspiration from the German Model
In this blog post, we delve into the DTx regulations of Belgium and France, focusing on their reimbursement strategies and providing a glimpse into how other EU member states fare in comparison.
Pharmacovigilance (PV) Audits: Importance, Process, and Challenges
Explore the crucial role of Pharmacovigilance (PV) audits in ensuring drug safety and compliance, the process, and the challenges faced.
MDR Certification for Legacy Devices: Integrating Clinical Evidence for Compliance
Find out what is required to maintain marketing approval for older devices in the EU.
Digital Therapeutics (DTx) in Germany: Pioneering “Deutsche Gründlichkeit” with Quality by Design
When it comes to the regulation of Digital Therapeutics (DTx), Germany is pioneering new paths for its adoption. This blog post delves into the intricacies of Germany’s approach to DTx regulation.
Quality Audits Management: Quality Audits managed according to QMS
GxP audits are the backbone of compliance and improvement. From risk-based planning to meticulous execution and compliance review, each step ensures organizational excellence. Embracing a PDCA (plan, do, check, act) life cycle approach streamlines processes and fosters consistency.
Quality and Regulatory Affairs: Key Elements of a Robust QMS in Pharma for Compliance and Success
Quality and Regulatory Affairs: Discover the key elements of Quality Management Systems in the pharmaceutical industry for compliance and success.
The Rise of Mobile Health: Taking a Closer Look at the EU Regulatory Landscape
For DTx manufacturers targeting the European market, compliance with regulation (EU) 2017/745 (MDR) is mandatory. Let’s delve into this regulatory aspect within the EU.
Continuous Manufacturing in the Pharmaceutical Industry: Enhancing Drug Production
Continuous manufacturing in the pharmaceutical industry enhances efficiency and product quality. Learn about CM’s implementation, control strategies, and ICH Q13 guidelines.
Mobile Health Ascending and the WHO’s Global Strategy on Digital Health
Explore the rise of Digital Therapeutics (DTx), covering its regulatory landscape, reimbursement perspectives, applications, and the WHO’s vision for digital health. Delve into how DTx bridges healthcare gaps and the future of digital health.
Anticipate the Notified Body Rush: Ensure Timely MDR Compliance
Learn key insights to meet the extended MDR compliance deadlines in time and ensure your device’s market access and patient safety.
MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK
Explore the MHRA’s new International Recognition Procedure (IRP) for medicines post-Brexit, and learn how to navigate regulations and the IRP’s two assessment routes for streamlined medicine registration in the UK.
Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations
Discover what is required to obtain and maintain marketing approval for Software Medical Devices in the EU.
CE approval for Medical Devices under MDR: key requirements for your device class
Explore the crucial steps for obtaining CE approval for your medical device under MDR. Learn more about the key aspects of conformity assessment tailored to each device class.
Qualifying a New GMP Facility: From Pitfalls to Best Practices
On the path to qualifying a new GMP facility? Learn about frequent pitfalls and the best practices we recommend to handle them.
Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects
Qualification and validation projects play a pivotal role in guaranteeing that pharmaceuticals, medical devices, and ATMPs meet stringent regulatory requirements. Learn more about QbD Group’s Project Management Process here.
Importing medicinal products into the EU? A Brief Guide to EU GMP Compliance.
Are you a medicinal product manufacturer looking to import into the EU in line with EU-GMP import regulations? Be sure to read this article.
Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.
Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA
In this blog post, we explore Computer Software Assurance (CSA), a modern alternative to traditional Computer System Validation (CSV), focusing on its crucial role in the pharmaceutical industry. Discover the key differences between CSA and CSV, the initial steps for transitioning from CSV to CSA, and why the CSA approach is increasingly important for ensuring system reliability, security, and compliance in drug development and manufacturing.
Understanding plasmids: small molecules with big implications
Explore the essentials of plasmid manufacturing and regulations for applications like gene therapy and vaccine development.
Oncolytic viruses: the use for cancer immunotherapy
Oncolytic viruses and cellular immunotherapy are creating significant new potential in the fight against cancer. Learn more about the working mechanism, risks, and specific biosafety requirements to be considered for oncolytic viruses.
Paperless Validation in Pharma: embrace the future
Discover the future of pharma: enhancing efficiency and cutting costs with paperless validation. Learn how to navigate the path to agility and innovation in the digital era.
GMP-compliant design of climate or stability chambers: the key to ensuring product integrity
In this blog post, we delve into the world of GMP-compliant design for climate chambers, unraveling the vital role they play in the stability testing of pharmaceutical products.
Regulatory guidelines for stability testing: a brief overview
In this blog post, we address key regulatory guidelines for stability testing to ensure high-quality products meet regulatory requirements and patient needs.
State Of The Art Literature Review – Process and Documentation
In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review for the clinical evaluation of your medical device.
4 Factors Influencing the Stability of Medicinal Products
In this blog post, we will explore the various factors that influence the stability of medicinal products and the parameters that need to be considered during their storage.
Digital Health in Pharma: Revolutionizing the Industry from R&D to Patient Care
AI, machine learning, blockchain, big data, and other buzzword technologies are making inroads into the biopharmaceutical sector, improving quality, traceability, and efficiency. Read more about how digital health is changing pharma here.
Mastering Cleanroom Qualification: navigating the latest regulatory updates
Discover the latest key changes in cleanroom qualification regulations, exploring the impact of the different test phases (qualification, classification, requalification, monitoring) with a focus on risk assessment.
Computerized System Validation in clinical trials: key considerations
Discover the importance of software validation in clinical trials. Learn how it applies to GCP and GMP systems. Stay ahead in the digital era.
State of the Art (SOTA) Literature Review – What, Why, When, and Who?
In this blog post, we would like to share with you the definitions, time points, and resources required to execute a systematic State of the Art (SOTA) literature review as required.
The Importance of Stability Testing in Pharmaceutical Development
In this blog post, we will delve deeper into the significance of stability testing in pharmaceutical development.
Pharma 4.0: The Future of Pharmaceutical Manufacturing
Discover how Pharma 4.0 is revolutionizing pharmaceutical manufacturing. Learn about the benefits, challenges and key components and how it improves efficiency, quality and patient safety.
Clinical Literature Review – Common Gaps and Hurdles to Take
In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature Review (SOTA).
EudraLex Volume 4 Annex 11: compliance checklist and future prospects
This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.
A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU
The past couple of years have borne witness to pivotal shifts in clinical trial approvals within the UK and EU. With the UK implementing the Combine Review system and the EU transitioning from a previous Directive to the EU Clinical Trials Regulation, both regions are aiming for enhanced efficiency, streamlined processes, and heightened transparency. Learn more here.
The EU Commission Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry
The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.
How to keep computerized systems in the operational phase?
Maintaining computerized systems during the operational phase is critical to the proper functioning of organizations. In this article, we explore some of the best practices for doing so.
Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare
Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!