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- Quickly bringing a new COVID-19 medical device to market for ZiggZagg
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- ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy
- ATMPs: Regulatory Do’s and Don’ts
- Clinical evaluation and investigations with medical devices
- Computer System Validation courses 2022
- Design and Development of Medical Devices
- Drug Device Combination Products and article 117
- Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
- From Concept to Market: Comprehensive Market Access Strategies for MDSW
- From Paper to Practice: Technical Documentation Essentials for Medical Device Software
- From Requirements to Code: Streamlining Your SaMD Development Cycle
- How to manage mandatory communication of Toxicological risks?
- Impact of the EU IVD Regulation on Clinical Drug Trials
- Implementation of Full EU FMD in Belgium and Luxembourg: what’s new?
- Intro to Cell and Gene therapy
- Is virtual manufacturing still possible under the IVDR?
- IVDR Extension Explained: Tips & Strategies!
- Medical Devices Risk Management according to ISO 14971:2019
- Medical devices: urgent needs vs regulation
- Post-Market Surveillance requirements for Medical Devices and IVDs
- Post-Market Surveillance requirements for Medical Devices and IVDs
- Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems
- Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems
- Setting up ATMP Quality Management Systems: Strategies for Compliance and Success
- Symposium AEFI 2024
- The basic concepts of the QbD methodology
- The Medical Device CE Certification Pathway Explained
- Unlocking strategic value in Drug Safety for Life Sciences organizations
- Unlocking strategic value in Safety for Life Sciences organizations
- Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices
- webinar on demand – How to manage mandatory communication of Toxicological risks?
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Blogs
- The Rise of Knowledge Process Outsourcing in Drug Safety: Smarter Outsourcing for Safer Healthcare
- Stay Ahead of Compliance: How to Effectively Manage Your Yearly Audits
- Mastering EU Product Information: The Role of the EMA’s Linguistic Review Process in Centralised Procedures
- Accurate but appealing: How our scientific copywriters and designers collaborate to create captivating content
- Outsourcing Internal Audits: Benefits and Process Optimization in Your Pharma Company
- Why scientists turn to communication: unlocking benefits for Life Sciences companies
- The Risk of Benzene Contamination in Drug Products: What Manufacturers Need to Know
- Friability and Disintegration for Oral Solid Dose Forms: The Forgotten Tests
- Toxicological Assessment of Extractables and Leachables (E&L)
- Analysing MHRA Performance: Clinical Trial and Amendment Applications in the UK
- Article 31 Referrals in Pharmacovigilance: A Brief Overview
- How to Assess and Improve the Readability of Medicines: A Complete Guide
- The Journey from Science to Story
- Analytical Method Transfer: Common Pitfalls and How to Avoid Them
- Elevate Pharma Imports with EU GMP Annexes 16 and 21
- The Holy Grail: Achieving Inspection Readiness
- Implementing PIC/S Standards in Hospital Cleanrooms: From Regulation to Application
- The Role of Artificial Intelligence (AI) in Pharmacovigilance in Europe: Advances and Legislation
- Curb Your Enthusiasm – How to Avoid Rushing into Your Business Development Efforts with Unexpected Cost Consequences
- Social Media in Pharmacovigilance: Harnessing Online Conversations for Drug Safety
- In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU
- Nitrosamine Impurities in Medicinal Products: Risks and Regulatory Insights
- What to expect when being inspected?
- Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?
- SCADA Automation in Pharma: Boosting Efficiency and Compliance
- Post-Market Success under IVDR: Prioritizing PMS & PMPF
- Impact of PDE Values on Cleaning Validation Design in Pharmaceutical Manufacturing
- Safeguarding Drugs: Controlling Elemental Impurities (ICH Q3D)
- The Crucial Role of Clinical Evidence in IVDR Compliance
- Regulatory Inspection Readiness: A Proactive Approach to CAPA and Compliance
- Why start building IVDR-compliant Technical Documentation now?
- Environmental Risk Assessments (ERA) in Pharma: Balancing Health & Environment
- Understanding the European Commission’s proposal for extending the transitional period for IVDs
- Drug-Device Combination Products and Article 117: How to Stay Compliant?
- Patient Support Programs: Enhancing Patient Care through Pharmacovigilance
- FDA’s QMSR Introduction: Aligning Device CGMP Regulations with ISO 13485:2016
- IVDR Transitional Extension: Why full speed ahead is still the best strategy
- Declaration of Equivalence for Medical Devices under the MDR
- A Deeper Dive into the MHRA Good Pharmacovigilance Practice (GPvP) Inspection Metrics and Findings
- Impact of the AI Act on the MedTech and Life Sciences Industry
- The Impact of EU IVDR on Clinical Trials
- MHRA to Launch RegulatoryConnect Portal in the UK: A New Era in Regulatory Management
- ICH Q2(R2) Validation of Analytical Procedures: An Overview of the Revised Guideline
- Exploring the U.S. Regulatory Framework for Mobile Health
- How to create a GMP-Compliant Stability Protocol?
- Digital Therapeutics in the UK: The Post-Brexit Landscape
- We Celebrate “International Women’s Day” by Putting the Spotlight on the QbD Group’s Power Ladies
- How to avoid non-compliance in the pharmaceutical industry
- Toxicology Challenges in Pharma: How to Address Them?
- The DTx Landscape in Belgium, France, and Their Inspiration from the German Model
- Pharmacovigilance (PV) Audits: Importance, Process, and Challenges
- MDR Certification for Legacy Devices: Integrating Clinical Evidence for Compliance
- Digital Therapeutics (DTx) in Germany: Pioneering “Deutsche Gründlichkeit” with Quality by Design
- Quality Audits Management: Quality Audits managed according to QMS
- Quality and Regulatory Affairs: Key Elements of a Robust QMS in Pharma for Compliance and Success
- The Rise of Mobile Health: Taking a Closer Look at the EU Regulatory Landscape
- Continuous Manufacturing in the Pharmaceutical Industry: Enhancing Drug Production
- Mobile Health Ascending and the WHO’s Global Strategy on Digital Health
- Anticipate the Notified Body Rush: Ensure Timely MDR/IVDR Compliance
- MHRA’s International Recognition Procedure Post Brexit: Navigating Medicinal Product Registration in the UK
- Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations
- CE approval for Medical Devices under MDR: key requirements for your device class
- Qualifying a New GMP Facility: From Pitfalls to Best Practices
- Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects
- Importing medicinal products into the EU? A Brief Guide to EU GMP Compliance.
- Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto
- Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA
- Understanding plasmids: small molecules with big implications
- Oncolytic viruses: the use for cancer immunotherapy
- Paperless Validation in Pharma: embrace the future
- GMP-compliant design of climate or stability chambers: the key to ensuring product integrity
- Regulatory guidelines for stability testing: a brief overview
- State Of The Art Literature Review – Process and Documentation
- 4 Factors Influencing the Stability of Medicinal Products
- Digital Health in Pharma: Revolutionizing the Industry from R&D to Patient Care
- Mastering Cleanroom Qualification: navigating the latest regulatory updates
- Computerized System Validation in clinical trials: key considerations
- State of the Art (SOTA) Literature Review – What, Why, When, and Who?
- The Importance of Stability Testing in Pharmaceutical Development
- Pharma 4.0: The Future of Pharmaceutical Manufacturing
- Clinical Literature Review – Common Gaps and Hurdles to Take
- EudraLex Volume 4 Annex 11: compliance checklist and future prospects
- A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU
- The EU Commission Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry
- How to keep computerized systems in the operational phase?
- Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare
- Automated software testing for the GxP world
- Analytical Method Validation: are your analytical methods suitable for intended use?
- MDR transition: how to plan MDR compliance for your Medical Device?
- ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway
- MHRA GMDP Symposium: key insights, trends, and best practices
- What is the Agile model in Computerized System Validation?
- EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights
- MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS)
- UK’s medicines regulator announces IT roadmap
- 7 key areas to focus on during internal or supplier audits
- 8 steps to successfully respond to non-conformities in an inspection report
- Celebrating International Women’s Day with power lady Elly De Bruyn, CHRO at the QbD Group
- Introduction to Digital Health in Clinical Trials
- What is the GAMP 5 V-model in Computerized System Validation?
- Essential Documents in Clinical Investigations with Medical Devices: a brief overview
- The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices
- Qualification of laboratory equipment: key considerations and challenges
- UDI for software: how to mark your MDSW with a UDI?
- Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?
- Medical Device and IVD industry trends for 2023
- Change Control Management: how to keep your systems compliant?
- Helping others is what brings the QbD Group joy every day
- The Advent of Artificial Intelligence and Machine Learning in Medical Devices
- Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges
- 5 tips to score a job as a Life Science consultant
- Medical Device development: the importance of Design Transfer and Process Validation
- QbD Group awarded Baanbrekende Werkgever ’23 certificate for the second year in a row
- What is digital health? Exploring the landscape and future opportunities.
- 21 CFR Part 11 compliance checklist: does your system comply?
- Team up with a Contract Research Organization (CRO) dedicated to medical devices to boost your clinical research strategy
- Finding your way through the maze of international, European, and harmonized standards for medical devices
- AI and machine learning validation: strategies and examples
- What is the purpose of Periodic Reviews in CSV?
- The importance of high-quality gas distribution networks for critical process gases, even in the early development phase
- GAMP 5 Guide 2nd Edition: what’s new?
- Why self-inspections or internal audits are essential for your QMS
- The regulatory pathway for your custom-made medical device
- Medicine advertising in Belgium: a brief regulatory overview
- PRRC under MDR and IVDR: meaning, requirements, and responsibilities
- 6 common myths about life sciences consultancy
- Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring
- Meet QbD Ambassador and Clinical Pharmacology & Pharmacometrics project lead Thomas Van Looy
- Data migration in CSV: definition, purpose, and best practices
- New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?
- Clinical Evaluation Report (CER): a must-have for all medical device classifications
- How to use electronic signatures in regulated industries?
- Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy
- What is decommissioning in CSV?
- Clinical evaluation for medical devices under MDR: a brief guide
- EDQM and the CEP of the future
- CAR-T cell therapy: main components, manufacturing, and prospects
- 10Y Dominiek Rossillion at QbD: from Quality Engineer to Business Development Manager
- What is EUDAMED and what new requirements should medical device companies take into account?
- GAMP categories for computerized systems: what are they and what are they for?
- 10 questions for ‘10Y anniversary girl’ Katrien Janssens
- 3D printing medical devices: enabling patient-specific solutions for a better quality of care
- The key role of Regulatory Affairs in the pharmaceutical industry: from development to commercialization
- Quality Control challenges in closed systems: implementing AI as an in-process control
- Cell therapy as an ATMP: introduction, definition, and subtypes
- 10 Questions for ‘10Y anniversary boy’ Jeroen Verhoeven
- QbD and TRIUM awarded with Baanbrekende Werkgever ‘22 certificate
- Dendritic (DC) cells: effective sentinels for immunotherapies
- Natural Killer (NK) cells: a major breakthrough in the field of ATMPs
- From IVDD to IVDR: avoid these pitfalls to get your CE marking in time
- Medical device combination products: what regulations should you apply before marketing them in the EU?
- IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers
- MDR impact on MDSW: what has changed from MDD?
- Medical Device Industry Trends: on wearables, AI, POC testing, IoT, and more
- QbD Academy welcomes 15 young graduates to jumpstart their careers in life sciences
- Unraveling Artificial Intelligence in Medical Devices: what do we know so far?
- SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?
- 5 consequences of Brexit when selling medical devices in the UK
- ATMPs: translating the expertise into a GMP process
- What is a medical device? Key definitions and regulations around the world.
- Why Medical Device Risk Management is as complex as it is crucial
- How QbD is investing in the new hybrid way of working
- Clinical Trials for ATMPs: which challenges to overcome?
- From idea to post market surveillance: the phases of the medical device lifecycle
- 10 things you should know before validating Computerized Systems
- Smart factories: How digital twins can strongly improve your ATMP manufacturing processes
- Why QP challenges in ATMPs are different & what you need to know!
- How do you reduce the Cost of Goods, which is key to affordable ATMPs?
- What you need to know to make your medical device UDI-ready in time
- Post-Market Surveillance of Medical Devices
- Medical devices: innovations versus regulations
- Is your ATMP platform robust enough to deal with material input variability?
- CAR T and TCRs for the market: current state and future perspectives
- Quality by design methodology for the pharmaceutical industry
- What to focus on when validating a computer system? (3)
- Automation Pyramid – FAQ
- What to focus on when validating a computer system? (2)
- Three important trends in technology transfers
- ATMP manufacturing for the market: main hurdles to be tackled to ensure a high-quality end product.
- What to focus on when validating a computer system
- The importance of a dedicated team and skilled project manager for technology transfers
- Tech transfer: what are the drivers of complexity?
- Technology transfers: these factors can make or break them
- Innovations in Medical Technology: The Future of Healthcare is Data
- Starting a new job in Corona times: this is how Katrien experienced it at QbD
- A Day in the QbD life of… Frederick Tison – Corona times
- Anything you need to know about ATMPs: FAQ
- ATMPs in a nutshell: what you should know about classification, quality and go to market
- Artificial Intelligence in Advanced Therapy Medicinal Products
- Computer Systems: is Assurance the new Validation?
- How will Brexit affect the pharmaceutical industry in European Union?
- Market release of vaccines: European Union versus the United States of America
- A day in the QbD life of… Julie, HR business partner at QbD HQ
- Technical Writing in Pharma and Biotech: Essential Tips
- Serialization in the EU can become a competitive advantage if you dare to innovate
- EU GMP Annex I: Are we ready for the challenges posed after its revision?
- Pioneering with Artificial Intelligence to make personalized cell therapy more accessible
- Updating Good Clinical Practice E6(R2)
- Preparing for growing challenges in pharmaceutical serialization
- Antleron & QbD team up to create a landslide in healthcare
- Data integrity in the pharma industry – a short introduction
- Eudralex Vol 4: New annex 15 – Qualification
News
- Annual Update event on the QbD Research Chair for Precision Oncology Research in Glioblastoma
- QbD Group Once Again Awarded Gold Label as Best Managed Company
- Timeseer.AI and the QbD Group sign a strategic partnership to serve the life sciences industry by improving sensor data quality
- QbD Chair for Precision Oncology Research in Glioblastoma extended for three years
- Salma Michor assumes role as Regulatory Affairs Division Head at the QbD Group
- Bart Van Acker established a Chair after close friend suffered from glioblastoma, an aggressive form of brain tumor
- QbD Group colleague Salma Michor named RAPS Fellow 2023
- The QbD Group acquires life sciences consultancy Azierta to reinforce its global vigilance services and expand its presence in Spain
- Belgians send miniature heart into space for ageing research
- The QbD Group acquires Turnstone Communications to strengthen its specialist science communication and business development services
- The QbD Group acquires Michor Consulting to enhance its regulatory affairs services across Europe
- QbD Group awarded Deloitte’s Best Managed Company Gold Label
- QbD Group Foundation: anchoring our social commitment
- Monkeys not Donkeys, QbD Group’s life science marketing and communication agency, strengthens its team
- The QbD Group acquires regulatory affairs and pharmacovigilance company EUDRAC Ltd. to expand its services for pharmaceutical customers
- Qarad’s eIFU services rebranded to ‘IFUcare’
- The QbD Group appoints new COO and Senior Director Integration to further align the Group’s international activities and acquisition integration processes
- QbD Group requalifies as Best Managed Company
- TRIUM Clinical Consulting is being rebranded to QbD Clinical
- Quality by Design (QbD) becomes QbD Group
- QbD acquires marketing & communication agency ‘Monkeys not Donkeys’ to strengthen its services within the life science industry.
- New office and strengthened team for QbD Wallonia
- QbD and Inovigate launch Health to Market, a contract commercialization organization in life sciences
- Quality by Design continues to grow: welcome Qarad!
- QbD Software Announces Major Rebranding: Scilife is Born.
- New partnership: QUERCUS Labo (QC) joins QbD Group
- Kanaal Z episode about QbD
- Quality by Design and TRIUM join forces
- QbD selected ‘Best Managed Company’ by Deloitte – Interview with CEO Bart Van Acker
- Bart van Acker (Quality by Design) named Flemish Young Entrepreneur of the Year
- QbD at Knowledge for Growth 2014
- Limoncello to a top-quality year
- New job announcement: consultants and project engineers
- Quality by Design in the launch issue of MARK Magazine
- Unique collaboration with Wase Werkplaats and Kunst+
- Quality by Design opens office in Leiden
- QbD whitepaper: Technology Transfer Needs a Lingua Franca
Regulatory Updates
- New MDCG Guidance documents released
- Amending Regulation (EU) 2024/1860 was published
- MDCG: First Revision on the Guidance on Standardisation for Medical Devices
- New Update of Appendix 1 of the Nitrosamines Guideline
- MDCG 2024-10 Clinical evaluation of orphan medical devices
- MDCG 2024-1-5 – Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence
- MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies
- Revision 2 of MDCG 2022-4 on MDR Appropriate surveillance
- New MDCG Guidance documents released
- New Notified Bodies Survey on certifications and applications (MDR/IVDR) MDCG & Stakeholders released
- Article 5.5 IVDR enforcement on in-house devices
- New update on Appendix 1 of the Nitrosamine Guideline
- EU Parliament Approves Proposal
- New guideline from the European Medicines Agency (EMA) on the Environmental Risk Assessment of medicinal products for human use
- New MDCG Guidance documents released: Content of the Investigator’s Brochure for clinical investigations of medical devices
- New MDCG Guidance documents released: Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
- New MDCG Guidance documents released: Guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices
- New MDCG Guidance documents released: Procedure for the updates of the European Medical Device Nomenclature (EMDN)
- New MDCG Guidance documents released: Device Specific Vigilance Guidance Document
- New MDR and IVDR harmonized standards published
- EU Council fully endorsed proposal to amend IVDR and MDR
- New proposal to amend IVDR and MDR – transitional provisions IVDR – EUDAMED gradual roll-out – Interruption of supply
- New IVDR/MDR overview of language requirements for manufacturers of medical devices
- New EMA FAQ on medicinal products development and assessment involving a CDx
- New MDCG Guidance documents released