The Clinical Evaluation Report (CER) comprises of three major parts that present complete clinicalevaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of the medical device along with compliance and experience records. The third part of the CER deals with the literature review of the clinical evaluation published on equivalent devices.
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Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Globalization of Clinical Trials: Mutual acceptance of Medical Device dataAnnet Visscher
Technologies and regulatory standards facilitate clinical trial globalization and mutual acceptance of clinical trial data. Changes in trial execution, however, are not 1:1 reflected in foreign data acceptance. Factors such as ethnic and local requirements seem to outweigh the benefits.
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
Informed consent Documents / Forms, Case Report /Record Form, Investigators Brochure, Study Protocol, Clinical Trial Documents, Life Sciences, BioStatistics.
Connect with me on LinkedIn @https://www.linkedin.com/in/jain-vidit/
If you need any help with this presentation
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLSKatalyst HLS
Introduction to Discovery of Drug and Introduction to Clinical Trials in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Literature screening for pharmacovigilance 190818Marnix Wieffer
Biomedical literature is an important source of drug adverse event reporting and Pharmacovigilance. However, due to the high volume of literature, sub-optimal search strategies and regulatory pressure, pharmaceutical companies are struggling to screen biomedical literature in a compliant and cost-effective manner.
This slide deck describes how, through outsourcing, automation and prioritization technology, we can significantly improve efficiency and compliance of literature screening.
The purpose of this presentation is to describe step by step the transition of a SAS Programmer into a Clinical Statistical Programmer. It can be used as guidelines for SAS Programmers who wants to put their programming and technical expertise into industries.
A SAS Programmer is someone who uses SAS software for different scenarios. The person who uses it for different purposes is known as a SAS Programmer.
On the other hand, a Clinical Statistical Programmer performs all the procedures to generate future outputs and makes advanced and real-world developments to face further challenges. A primary role of Clinical Statistical Programmers is to use their technical and programming skills in order to enable clinical trial statisticians to perform their statistical analysis duties more efficiently.
This presentation will briefly discuss about the smooth transition that a SAS Programmer needs to go through in order to become a Clinical Statistical Programmer.
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
Epoch provides training to students, professionals and corporate on SAS®, Data Management Activities and soft skills. Training includes Software Programming, Clinical, Analysis and Analytics modules, which can be availed by professionals with IT, Life Sciences, Medical, Statistics, MBA and such other backgrounds. Epoch is the pioneer in the courses designed of SAS designed for Clinical Programming world.
www.epoch.co.in, info@epoch.co.in
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Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
Informed consent Documents / Forms, Case Report /Record Form, Investigators Brochure, Study Protocol, Clinical Trial Documents, Life Sciences, BioStatistics.
Connect with me on LinkedIn @https://www.linkedin.com/in/jain-vidit/
If you need any help with this presentation
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLSKatalyst HLS
Introduction to Discovery of Drug and Introduction to Clinical Trials in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Literature screening for pharmacovigilance 190818Marnix Wieffer
Biomedical literature is an important source of drug adverse event reporting and Pharmacovigilance. However, due to the high volume of literature, sub-optimal search strategies and regulatory pressure, pharmaceutical companies are struggling to screen biomedical literature in a compliant and cost-effective manner.
This slide deck describes how, through outsourcing, automation and prioritization technology, we can significantly improve efficiency and compliance of literature screening.
The purpose of this presentation is to describe step by step the transition of a SAS Programmer into a Clinical Statistical Programmer. It can be used as guidelines for SAS Programmers who wants to put their programming and technical expertise into industries.
A SAS Programmer is someone who uses SAS software for different scenarios. The person who uses it for different purposes is known as a SAS Programmer.
On the other hand, a Clinical Statistical Programmer performs all the procedures to generate future outputs and makes advanced and real-world developments to face further challenges. A primary role of Clinical Statistical Programmers is to use their technical and programming skills in order to enable clinical trial statisticians to perform their statistical analysis duties more efficiently.
This presentation will briefly discuss about the smooth transition that a SAS Programmer needs to go through in order to become a Clinical Statistical Programmer.
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
Epoch provides training to students, professionals and corporate on SAS®, Data Management Activities and soft skills. Training includes Software Programming, Clinical, Analysis and Analytics modules, which can be availed by professionals with IT, Life Sciences, Medical, Statistics, MBA and such other backgrounds. Epoch is the pioneer in the courses designed of SAS designed for Clinical Programming world.
www.epoch.co.in, info@epoch.co.in
#bigdata
#hadoop
#sastraining
#epochsastraining
#sasonlinetraining
#clinicalprogramming
#epochsasonlinetraining
#epochresearchinstitute
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
Challenges and Opportunities Around Integration of Clinical Trials DataCitiusTech
Conducting a Clinical Trial is a complex process, consisting of activities such as protocol preparation, site selection, approval of various authorities, meticulous collection and management of data, analysis and reporting of the data collected
Each activity is benefited from the development of point applications which ease the process of data collection, reporting and decision making. The recent advancements in mobile technologies and connectivity has enabled the generation and exchange of a lot more data than previously anticipated. However, the lack of interoperability and proper planning to leverage this data, still acts as a roadblock in allowing organizations truly harness their data assets. This document will help life sciences IT professionals and decision makers understand challenges and opportunities around clinical data integration
Systemic reviews on implantable medical devices provide a quality of reportin...Pubrica
• Defining active implantable medical devices
• Literature search
• Eligibility criteria and citation screening
• Data extraction
• Reporting of device or procedure-specific data
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When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
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Dr. Jules Mitchel, President of Target Health, delivered this presentation on the new FDA Guidance on the use of the electronic health record for clinical research at the North American eClinical Forum Autumn Meeting on October 2, 2018.
Final navigating multiple clinical trial requirements for the usBhaswat Chakraborty
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
The secret formula to getting health tech to marketDr Hugh Harvey
The UK Israel Tech Hub has partnered with some of the UK’s leading healthcare consultancies to bring you this carefully curated series to help demystify the UK and its wonderful National Health Service, focusing on getting back to business and not on COVID-19.
Where do clinical evaluation and clinical investigation intersectI3CGLOBAL
Clinical Evaluation is the process of collecting and assessing all clinical data related to a device and evaluating whether sufficient clinical evidence exists to support conformity with regulatory requirements. The clinical investigation is often the most important evidence needed to prove your medical device is ready for market.
Different sources of data used to extract for writing a systematic review – p...Pubrica
Systematic reviews have studied rather than reports as the unit of interest. So,many reports of the same study need to be identified and linked together before or after data extraction
• Different Sources of data
• Data Extraction Tools
Continue Reading: https://bit.ly/3c4KMps
For our services: https://pubrica.com/services/research-services/systematic-review/
Why Pubrica:
When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
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Web: https://pubrica.com/
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Preparing for a New Time in Medical Literature MonitoringCovance
In recent times, pharmacovigilance regulations have focused increasingly more on medical literature monitoring (MLM), a complex process whose scope continues to expand and deepen. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Systematic review of quality standards for medical devices and practice measu...Pubrica
A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified articles describing either a general MDR structure or the development process of specific registries.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3MCXLOK
Why Pubrica:
When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
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Similar to Importance of systematic literature search for clinical evaluation (CE) the strict adherence of meddev 2.7.1 (20)
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
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Different Stages of Medical Device Development and Drug Development: PepgraDi...PEPGRA Healthcare
The difference between medical device product development and pharmaceuticals that are supposed to be launched are based on industry composition where above 80% small and medium-sized companies require medical devices and large multinational organizations seek new medicines. Pepgra gives you the different stages of Medical Device Development and Drug Development, some are:
1. Lead discovery optimization
2. Pre-clinical Research
3.. Clinical Research
4. Post- Market safety monitoring
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Youtube: https://www.youtube.com/watch?v=cYz_BOArGhA
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Top 5 tips for managing risks in your clinical studies - PepgraPEPGRA Healthcare
Fronting ever-increasing costs of running a clinical trial, sponsors must guarantee they are correctly directing their financial plan and resolving the highest risk areas while preserving patient safety and data reliability in Patient recruitment for clinical trials. In this blog, Pepgra provides five tips for significant risk levels in clinical studies like:
1. Outlining your levels of risks
2. Evaluating and categorizing risk
3. Concentrating on essential areas of risk
4. Observing and controlling risks
5. Estimating the efficiency of risk management
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Role of Biostatistician and Biostatistical Programming in Epidemiological Stu...PEPGRA Healthcare
Pepgra experts provide regulatory biostatistics and epidemiology statistical programming support to all phases of clinical trial process development and commercialization. Our Epidemiological statistical services is are located globally & trained in current methods and standards to support the successful execution of your projects.
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EMA Guidelines for Clinical Trial Management - Pepgra HealthcarePEPGRA Healthcare
The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. EMA guidelines for clinical trial regulations adopted in 2014 aim to make it easier for the clinical trials companies while empowering participants through transparency.
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Side effects of drugs products, medical devices & drugs healthcare data...PEPGRA Healthcare
Rapid growth in the use of medical devices in health-care sectors has been enabled by technological advancements. Prescription drugs and medical devices can come with dangerous side effects and complications. A side effect will become severe, so it is essential to contact your doctor or pharmacy specialist if you face ant difficulties. In this blog, Pepgra lists the reporting of side effects and its necessities.
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Guidance for Biomarkers into Early Phase Clinical Research Purposes | Healthc...PEPGRA Healthcare
In many health data analytics companies, Biomarkers are playing increasingly critical roles in the development of new drugs in early-phase trials. This blog is meant to introduce clinical investigators to the fundamentals of choosing a biomarker test for use in an early phase trial. Some steps to consider are briefly outlined including defining the role of the biomarker in the early phase trial are:
Errors in Measurement, Bigotry, Astounding, Price and Acceptability.
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Recent trends in genomic biomarkers pepgra healthcarePEPGRA Healthcare
Cardiovascular disease is a significant health concern worldwide despite having many genomics developments providing valuable new candidates for better biomarkers and novel therapeutic targets. The main integration of new technologies promises the discovery and validation of better biomarkers of the presence of cardio disease, its progression, and the response to treatment in this blog. Some of the features are:
1. Analyzing the Gene expression
2. Genome-wide association studies
3. Linkage analysis
4. Wrapping up...
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Recent Trends in Genomic Biomarkers - Pepgra HealthcarePEPGRA Healthcare
Cardiovascular disease is a significant health concern worldwide despite having many genomics developments providing valuable new candidates for better biomarkers and novel therapeutic targets. The main integration of new technologies promises the discovery and validation of better biomarkers of the presence of cardio disease, its progression, and the response to treatment in this blog. Some of the features are:
1. Analyzing the Gene expression
2. Genome-wide association studies
3. Linkage analysis
4. Wrapping up...
Continue Reading: http://bit.ly/3bqq3Np
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Guidelines on Virtuous Pharmacovigilance Practices | Pepgra HealthcarePEPGRA Healthcare
Pepgra explains the general guidelines of pharmacovigilance for all clinical research organization. Medical-related problems for the Clinical trial monitoring services have a considerable impact on the pharmacovigilance process as it detects monitors and analyze the medical activities. Some general guidelines to promote the regulations in health care sectors are given below:
• Planning of quality
• Adherence to quality
• Quality assurance and control
• Improvements in quality
• Documenting the legal requirements
• Protecting humans from the adverse effects
• Building safe and practical applications
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SaMD or Software as a Medical Device can be described as a software constructed to be used in medical devices. These softwares can be run on different operating systems and virtual platforms.
1. The basic programming model of a SaMD is given below.
2. Different softwares are used for medical purposes, and they include the following:
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•The major steps in conducting a clinical trial study are study design, study conduct, data analysis and reporting of the findings.
•Randomized clinical trials are deemed as a gold standard method for analyzing and evaluating the safety and effectiveness of medical devices or pharmaceutical drugs.
•The most challenging part of conducting a randomized clinical trial are related to handling ethical and regulatory systems.
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Risk managements documents required for the market placement of a medical dev...PEPGRA Healthcare
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
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A few dedicated search engines for your medical writingPEPGRA Healthcare
A medical literature search engine is a centralized browser-based platform which will come up with literature related to any of the medical subjects you choose. This is perhaps not a good idea to seek help of every medical resources discussed in this blog, yet using a few of the medical literature search engines will definitely serve the purpose of your constant source of authentic evidence.
To Continue Reading : https://bit.ly/35KkzYL
Clinical Trial Design and Artificial Intelligence | Pepgra.comPEPGRA Healthcare
Clinical trials take up the last half of the 10 – 15 year, 1.5 – 2.0 billion USD, cycle of development just for introducing a new drug within a market.
1. AI and its Evolution
2. AI in Clinical Trials
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Medical literature monitoring and entering negative reaction reportsPEPGRA Healthcare
1. A novel process where European Medical Agency offers a new service.
2. The service is focused around medical literature monitoring.
3. This service is also a vital step to ensure that there is no duplication of negative reaction reports.
4. This service came into effect from 1st September, 2015.
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Pharmacovigilance Literature Search Services - https://bit.ly/2wM7IIH
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New medical device regulation: implications for medical device manufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
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New Medical Device Regulation Implications For Medical Device ManufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn more: https://www.pepgra.com/device-manufacturers/
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Uk: +44- 7424810299
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Relevant Medical Databases and Search Engines for Literature ScreeningPEPGRA Healthcare
A medical literature search engine is a centralized browser-based platform which will come up with literature related to any of the medical subjects you choose. These search engines are programmed to be connected with the archives of published literature that are stored inside online subject-specific academic databases like the medical literature database.
Learn More: https://www.pepgra.com/relevant-medical-databases-and-search-engines-for-periodic-literature-screening/
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.