A comprehensive educational program by way of webinar-based and interactive sessions providing important background, education and expert-moderated panel discussions of topics relevant to UDI compliance, best-practice and future trends.
The £100bn customer; doing business with the NHSENGAGE_Events
Do you want to engage with one of the UK’s biggest organisations? Not sure where to start? These slides are from our free event in partnership with Wessex Academic Health Science Network that delved into the intricacies of working with the NHS. To find more events like this, visit www.science-park.co.uk/events
GS1 UK Healthcare Conference - Masterclass Presentation - Rob DragGS1 UK
This document discusses improving the purchase-to-pay (P2P) process in healthcare organizations. It notes that implementing standards like barcodes, a master data set, and electronic invoices can increase efficiency in the P2P cycle from sourcing to inventory management. However, technology alone is not enough - the process also needs to consider people, updated policies, communication, and data quality. Following standards fully and understanding where current processes have issues are keys to realizing benefits like enhanced spend analytics, increased visibility, traceability from manufacturer to patient, and freeing up clinical time. The main takeaways are to start by understanding current processes, plan for sustainable long-term changes, and recognize that systems and standards only form part of
White Plains Youth Bureau’s After School Connection ProgramMadhu Kumar
A graduate of the Massachusetts Institute of Technology, Madhu Kumar most recently served as a scientific advisor for Wilson Sonsini Goodrich & Rosati, where he drafted and prosecuted patent applications in the pharmaceutical and life sciences industries. Madhu Kumar has also tutored children and youths through the White Plains Youth Bureau.
This document announces an event taking place from September 12-14, 2016 in Berlin, Germany on overcoming silo structures in regulatory operations and reshaping regulatory information management with IDMP. The event will feature presentations from experts in regulatory operations and information management from various pharmaceutical companies including AstraZeneca, Janssen Pharmaceutical, Novo Nordisk, LEO Pharma, Meda Pharma, and Boehringer Ingelheim. Attendees will learn about regulatory excellence, becoming ready for IDMP and regulatory information management standards from these industry leaders.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
Free webinar on Unique Device Identificationnykathlen
The document discusses planning and implementation of Unique Device Identification (UDI) requirements within the medical device industry. It outlines a six step process: 1) Developing a UDI compliance plan, 2) Understanding machine readable technology, 3) Managing change, 4) Conducting risk assessments, 5) Implementing UDI across the value chain, and 6) Identifying data sources for FDA reporting. It also provides an overview of compliance dates for UDI labeling and data submission requirements based on device class.
The £100bn customer; doing business with the NHSENGAGE_Events
Do you want to engage with one of the UK’s biggest organisations? Not sure where to start? These slides are from our free event in partnership with Wessex Academic Health Science Network that delved into the intricacies of working with the NHS. To find more events like this, visit www.science-park.co.uk/events
GS1 UK Healthcare Conference - Masterclass Presentation - Rob DragGS1 UK
This document discusses improving the purchase-to-pay (P2P) process in healthcare organizations. It notes that implementing standards like barcodes, a master data set, and electronic invoices can increase efficiency in the P2P cycle from sourcing to inventory management. However, technology alone is not enough - the process also needs to consider people, updated policies, communication, and data quality. Following standards fully and understanding where current processes have issues are keys to realizing benefits like enhanced spend analytics, increased visibility, traceability from manufacturer to patient, and freeing up clinical time. The main takeaways are to start by understanding current processes, plan for sustainable long-term changes, and recognize that systems and standards only form part of
White Plains Youth Bureau’s After School Connection ProgramMadhu Kumar
A graduate of the Massachusetts Institute of Technology, Madhu Kumar most recently served as a scientific advisor for Wilson Sonsini Goodrich & Rosati, where he drafted and prosecuted patent applications in the pharmaceutical and life sciences industries. Madhu Kumar has also tutored children and youths through the White Plains Youth Bureau.
This document announces an event taking place from September 12-14, 2016 in Berlin, Germany on overcoming silo structures in regulatory operations and reshaping regulatory information management with IDMP. The event will feature presentations from experts in regulatory operations and information management from various pharmaceutical companies including AstraZeneca, Janssen Pharmaceutical, Novo Nordisk, LEO Pharma, Meda Pharma, and Boehringer Ingelheim. Attendees will learn about regulatory excellence, becoming ready for IDMP and regulatory information management standards from these industry leaders.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
Free webinar on Unique Device Identificationnykathlen
The document discusses planning and implementation of Unique Device Identification (UDI) requirements within the medical device industry. It outlines a six step process: 1) Developing a UDI compliance plan, 2) Understanding machine readable technology, 3) Managing change, 4) Conducting risk assessments, 5) Implementing UDI across the value chain, and 6) Identifying data sources for FDA reporting. It also provides an overview of compliance dates for UDI labeling and data submission requirements based on device class.
Step-by-Step Approach of Unique Device Identification (UDI)VISAMED GmbH
This document outlines the step-by-step approach for implementing Unique Device Identification (UDI) as required by the FDA. It discusses the history and objectives of UDI, what constitutes a UDI, how UDI benefits patient safety and supply chain efficiency, and the challenges involved in assigning UDIs, modifying packaging and labels, submitting UDI data to the Global UDI Database, and ensuring ongoing compliance. A high-level task list is provided to guide planning and execution of a company's UDI implementation project.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Europe CE Marking for medical devices under new MDREMERGO
Starting in early 2020, medical devices seeking CE Marking certification in Europe must comply with the new Medical Device Regulation (MDR). This will require appointing personnel responsible for regulatory compliance, classifying the device, appointing an Authorized Representative located in the EU, including labeling with this information, and obtaining a Single Registration Number. Manufacturers must also prepare technical documentation, implement a quality management system, and undergo annual audits by a Notified Body to maintain certification.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Unique Device Identification A Manufacturers ViewGS1 Nederland
This document discusses the challenges medical device manufacturers will face in implementing Unique Device Identification (UDI). It argues that a step-wise implementation timeline is needed as UDI regulations will require adding variable data to automatic identification and data capture (AIDC) markings on individual medical device packages and products. This will be technically challenging due to limited space for small AIDC carriers, requirements to print variable data inline during high-speed packaging, and ensuring the quality and scannability of AIDC markings on different packaging materials. The document advocates for reviewing results between implementation steps to adjust systems as needed before expanding UDI to additional device classes.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Step-by-Step Approach of Unique Device Identification (UDI)VISAMED GmbH
This document outlines the step-by-step approach for implementing Unique Device Identification (UDI) as required by the FDA. It discusses the history and objectives of UDI, what constitutes a UDI, how UDI benefits patient safety and supply chain efficiency, and the challenges involved in assigning UDIs, modifying packaging and labels, submitting UDI data to the Global UDI Database, and ensuring ongoing compliance. A high-level task list is provided to guide planning and execution of a company's UDI implementation project.
How to Make Postmarket Surveillance More Cost EffectiveApril Bright
When it comes to postmarket surveillance (PMS), it’s common for the costs to outweigh the value. But, by working with the right team, you’ll be able to execute a study that maximizes return on investment and minimizes the financial impact of conducting further observational research. Postmarket study challenges that must be addressed include enrollment delays, patient attrition, long-term follow-up, resourcing demands and global payor requirements. This session will provide a case study of one orthopaedic company’s seamless transition between postmarket approval and post-approval studies.
Europe CE Marking for medical devices under new MDREMERGO
Starting in early 2020, medical devices seeking CE Marking certification in Europe must comply with the new Medical Device Regulation (MDR). This will require appointing personnel responsible for regulatory compliance, classifying the device, appointing an Authorized Representative located in the EU, including labeling with this information, and obtaining a Single Registration Number. Manufacturers must also prepare technical documentation, implement a quality management system, and undergo annual audits by a Notified Body to maintain certification.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Unique Device Identification A Manufacturers ViewGS1 Nederland
This document discusses the challenges medical device manufacturers will face in implementing Unique Device Identification (UDI). It argues that a step-wise implementation timeline is needed as UDI regulations will require adding variable data to automatic identification and data capture (AIDC) markings on individual medical device packages and products. This will be technically challenging due to limited space for small AIDC carriers, requirements to print variable data inline during high-speed packaging, and ensuring the quality and scannability of AIDC markings on different packaging materials. The document advocates for reviewing results between implementation steps to adjust systems as needed before expanding UDI to additional device classes.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.