Siemens Healthcare Diagnostics is committed to providing clinicians with vital diagnostic information through its comprehensive portfolio of clinical diagnostics systems and solutions. This includes the CLINITEK Status family of urinalysis analyzers which feature automated and reliable testing, optional connectivity capabilities, and a broad test menu to support patient care. The new CLINITEK Status+ Analyzer offers additional enhancements like automated quality checks and printed records for accurate results.
SCIEX is a provider of analytical tools and technologies for life science research and clinical diagnostics. Its vision is to provide integrated solutions to advance scientific understanding and safeguard health. It serves markets including pharmaceuticals and biopharma, clinical diagnostics, forensics, food and environment, and life science research. SCIEX offers a range of mass spectrometry, liquid chromatography, and capillary electrophoresis instruments, as well as software and services. It has over 40 years of experience innovating new technologies and has operations worldwide.
The document provides information about the 10th Annual Clinical Trial Logistics conference taking place on May 18-19, 2016 in London. The conference will discuss key topics in clinical trial logistics, including regulatory updates, temperature excursion management, labeling requirements, and implementing patient-centric supply strategies. Featured speakers will represent organizations like PAREXEL, Teva, Norgine, and Sanofi. Attendees can gain insights on challenges in air freight shipping, using technology to enhance supply chain visibility, and comparator sourcing. The conference aims to help participants adapt their clinical trial logistics practices to the evolving regulatory landscape.
1) Narvitas Medical Devices develops, patents, manufactures and sells proprietary medical devices across 3 initial platforms leveraging a core technology.
2) The management team includes co-founders with experience at large medical device companies and a hospital.
3) The company is developing a new modality called LapDome to improve laparoscopic surgery by providing a safer alternative to the standard Veress needle technique for pneumoperitoneum.
4) Narvitas is working with engineering design firms to develop initial devices and has filed for intellectual property protection.
The document discusses upcoming changes to European medical device regulations as outlined in a new proposal for revising the Medical Device Directive. Key points include stricter clinical data requirements, changes to device classifications, expanded scope and definitions, and more stringent post-market surveillance and vigilance reporting timelines. The revisions aim to harmonize regulations across EU member states and increase oversight of medical devices and manufacturers.
Presentation: Cybersecurity considerations for medical devices - From the TGA...TGA Australia
The Australian regulatory framework for medical devices already captures cybersecurity. Manufacturers have been considering security in their design, and the Therapeutic Goods Administration (TGA) has been assessing and regulating the security of medical devices through the Essential Principles. However, the number of networked devices is growing, the risk profile is changing, and public awareness of cybersecurity as a risk is increasing.
This changing landscape has created new challenges for regulators of medical devices, including poor or unclear standardisation, sharing information, publication of vulnerabilities and exploits by users and security researchers, and poor transparency of expectations between stakeholders.
TGA is currently undertaking multiple projects to improve the regulation of medical device cybersecurity in Australia. These include, building on the existing capabilities to assess and measure medical device security, consulting with industry and other stakeholders on their challenges and expectations, and working to improve standardisation.
Actimus Biosciences Pvt Ltd is a clinical research organization founded in 2005 in Visakhapatnam, India. It is led by Chairman and Managing Director Ramnath Reddy, who has experience in the healthcare and pharmaceutical industries. The company has facilities for clinical trials including two clinics with 72 beds and laboratories equipped for bioanalytical work. It provides clinical trial services and has experience conducting over 350 studies.
Siemens Healthcare Diagnostics is committed to providing clinicians with vital diagnostic information through its comprehensive portfolio of clinical diagnostics systems and solutions. This includes the CLINITEK Status family of urinalysis analyzers which feature automated and reliable testing, optional connectivity capabilities, and a broad test menu to support patient care. The new CLINITEK Status+ Analyzer offers additional enhancements like automated quality checks and printed records for accurate results.
SCIEX is a provider of analytical tools and technologies for life science research and clinical diagnostics. Its vision is to provide integrated solutions to advance scientific understanding and safeguard health. It serves markets including pharmaceuticals and biopharma, clinical diagnostics, forensics, food and environment, and life science research. SCIEX offers a range of mass spectrometry, liquid chromatography, and capillary electrophoresis instruments, as well as software and services. It has over 40 years of experience innovating new technologies and has operations worldwide.
The document provides information about the 10th Annual Clinical Trial Logistics conference taking place on May 18-19, 2016 in London. The conference will discuss key topics in clinical trial logistics, including regulatory updates, temperature excursion management, labeling requirements, and implementing patient-centric supply strategies. Featured speakers will represent organizations like PAREXEL, Teva, Norgine, and Sanofi. Attendees can gain insights on challenges in air freight shipping, using technology to enhance supply chain visibility, and comparator sourcing. The conference aims to help participants adapt their clinical trial logistics practices to the evolving regulatory landscape.
1) Narvitas Medical Devices develops, patents, manufactures and sells proprietary medical devices across 3 initial platforms leveraging a core technology.
2) The management team includes co-founders with experience at large medical device companies and a hospital.
3) The company is developing a new modality called LapDome to improve laparoscopic surgery by providing a safer alternative to the standard Veress needle technique for pneumoperitoneum.
4) Narvitas is working with engineering design firms to develop initial devices and has filed for intellectual property protection.
The document discusses upcoming changes to European medical device regulations as outlined in a new proposal for revising the Medical Device Directive. Key points include stricter clinical data requirements, changes to device classifications, expanded scope and definitions, and more stringent post-market surveillance and vigilance reporting timelines. The revisions aim to harmonize regulations across EU member states and increase oversight of medical devices and manufacturers.
Presentation: Cybersecurity considerations for medical devices - From the TGA...TGA Australia
The Australian regulatory framework for medical devices already captures cybersecurity. Manufacturers have been considering security in their design, and the Therapeutic Goods Administration (TGA) has been assessing and regulating the security of medical devices through the Essential Principles. However, the number of networked devices is growing, the risk profile is changing, and public awareness of cybersecurity as a risk is increasing.
This changing landscape has created new challenges for regulators of medical devices, including poor or unclear standardisation, sharing information, publication of vulnerabilities and exploits by users and security researchers, and poor transparency of expectations between stakeholders.
TGA is currently undertaking multiple projects to improve the regulation of medical device cybersecurity in Australia. These include, building on the existing capabilities to assess and measure medical device security, consulting with industry and other stakeholders on their challenges and expectations, and working to improve standardisation.
Actimus Biosciences Pvt Ltd is a clinical research organization founded in 2005 in Visakhapatnam, India. It is led by Chairman and Managing Director Ramnath Reddy, who has experience in the healthcare and pharmaceutical industries. The company has facilities for clinical trials including two clinics with 72 beds and laboratories equipped for bioanalytical work. It provides clinical trial services and has experience conducting over 350 studies.
Eurogentec is a leading supplier of reagents, kits, and custom services for life science research, diagnostics, and biomanufacturing. It provides high-quality products that support scientists in research, biotechnology, diagnostics, and pharmaceuticals. Eurogentec has headquarters in Belgium and subsidiaries worldwide, employing over 320 people including more than 40 PhDs. Eurogentec has been a part of Kaneka Corporation, a large Japanese chemical company, since 2010.
Prosoft Clinical Services and Capabilities provides clinical trial services including CMC formulation development, biostatistics, data management, clinical operations, medical writing, and regulatory strategy and operations. They have experience across multiple therapeutic areas like allergy/respiratory, CNS, dermatology, heart failure, HIV, hypertension, oncology, pain, and women's health. Their team has extensive experience developing products through all phases of clinical trials and regulatory approval.
The document summarizes a sales meeting focused on taxane-related products, noting that taxanes require significant engineering for their formulation and that drugs like docetaxel and vinorelbine will become off-patent in the near future, presenting an opportunity. It provides details on companies developing lipid-soluble taxane products and clinical trials underway, and highlights a recent investigational new drug application filed for a novel liposomal docetaxel delivery system.
Thermo Fisher Scientific India Pvt. Ltd. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and approximately 55,000 employees globally. Our mission through our premier brands Thermo Scientific, Applied Bio Systems, Invitrogen, Fisher Scientific and Unity Lab Services, we offer an unmatched combination of innovative is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. We offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.
Diagenode is a privately held Belgian biotech company focused on developing and commercializing high-value epigenetics products for research and diagnostics. It has a strong reputation for expertise in sonication and leadership in epigenetics research. Diagenode has a market leadership position in epigenetics and offers innovative automated systems like the SX-8G IP-Star for chromatin immunoprecipitation and methylation assays, and the BioruptorNGS for next generation sequencing applications. The company aims to make epigenetics research more accessible, automated, and consistent through products like its sonication and automated platform technologies.
A smart enteral feeding system with integrated reflux monitoring and prevention. The system comprises of both proprietary hardware and software. A
feeding tube (LifeSafe Tube™) with embedded sensors collects data continuously. Proprietary algorithms analyze the collected data, weighing multiple risk factors such as patient position and physiological functions (ie: sneezing, coughing) to predict when reflux will occur. This information is used to automatically calibrate a feeding pump and optimize feeding rate in order to prevent reflux.
- Narvitas Medical Devices develops proprietary medical devices to improve laparoscopic and epidural procedures.
- Their first product, LapDome, provides safer and faster abdominal access during laparoscopic surgery compared to current Veress needle methods, addressing a $15 million market that is growing 8.3% annually.
- The management team has experience in medical device companies and regulatory approval processes. Financial projections estimate positive EBITDA by 2016 and growing profits through 2017 as the company expands into new markets.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
1) Anteo Diagnostics will partner with Atomo Diagnostics to develop a rapid blood test for early detection of heart attacks using Anteo's coating technology and Atomo's AtomoRapid platform.
2) Atomo received $100,000 in funding from the Advance Queensland Johnson & Johnson Innovation QuickFire Challenge to create a proof of concept for their rapid heart attack test.
3) If the proof of concept is successful, Atomo and Anteo will consider fully commercializing an AtomoRapid-based cardiac troponin test, which could improve on current tests in the large and growing $350 million point-of-care cardiac biomarkers market.
Roger Rocha Placement Presentation AusDiagnostics.pptxRogerCoca
This document provides information about a laboratory technician placement opportunity at AusDiagnostics UK Ltd. for Roger Rocha, a BSc Biomedical Science student at Sheffield Hallam University. AusDiagnostics is an international biotechnology company that specializes in multiplex PCR diagnostic kits. The placement would involve tasks in laboratory maintenance, quality control, production assistance, and office administration to develop technical and professional skills. The document notes benefits such as experience in a fast-paced environment and opportunities for graduate roles or industry work.
Far Gene Pouyesh Iranian is an Iranian company established in 1996 that imports laboratory equipment for life sciences, nano-bio, and agro-food. It has over 30 employees across scientific, R&D, sales, administrative, financial, commercial, and technical departments. The company generates an annual turnover of $2.8 million and is headquartered in Tehran. Far Gene provides services including after-sales support, customer satisfaction assessments, equipment repairs and training. It works with overseas suppliers and has an agent in West Azerbaijan province. The company values integrity, employee well-being, superior customer service and long-term value.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Eldrug S.A is a biotechnology company established in 2007 and located in Patras, Greece that specializes in drug discovery and development. It has received over 6 million euros in funding from various sources including VIANEX S.A and the Greek Ministry of Development to develop peptides and peptide mimetics for clinical trials targeting conditions like multiple sclerosis and hypertension. Eldrug collaborates with various academic institutions and has won several awards for its innovative research projects.
Presentation given at the Garage Start Digital Health Startup Workshop sponsored by ABRT Venture Capital. Content focuses on the healthtech investment landscape.
TetraQ is a preclinical drug development facility located at the University of Queensland in Brisbane, Australia. It was founded in 2005 by four experts in the core areas of preclinical drug development - efficacy, ADME, toxicology, and pharmaceutics. TetraQ provides a range of preclinical services including efficacy testing in disease models, ADME/pharmacokinetic studies, toxicology testing, and formulation development to assess drug candidates and help reduce risks prior to clinical trials. The services help determine whether drug candidates are likely to be safe and effective enough to advance to human studies.
WerfenLife is a global healthcare company dedicated to research, development, manufacturing and distribution of specialized healthcare products. In 2015, WerfenLife achieved sales of 1.175 billion euros, a 14% increase over 2014. WerfenLife's key business divisions saw growth, with Werfen increasing 6.7% and Medical Devices and Distribution also experiencing gains. WerfenLife invested heavily in R&D and new facilities to drive innovation and growth. Looking ahead to 2016, WerfenLife expects continued positive trends and plans further investments in areas like R&D, commercial expansion and new facilities to maximize its leadership in specialized healthcare.
Alyante is a custom research services organisation that delivers quality research to help improve your research efficiencies. It provides comprehensive end-to-end solutions ranging from chemical and pharmaceutical development to product supply, including complete regulatory support for filing. To enhance your product portfolio, Alyante offers innovative services including NDDS.
Alyante’s array of innovation-based services and commitment to excellence will help you create new value.
Alyante is an assurance of an alliance that strives to keep your research always ahead of the competition through innovation and trust.
Easy Earnings Through Refer and Earn Apps Without KYC.pptxFx Lotus
Learn how to make extra money with refer and earn apps that don’t require KYC. Find out the advantages, top apps, and strategies to boost your earnings quickly and easily.
Eurogentec is a leading supplier of reagents, kits, and custom services for life science research, diagnostics, and biomanufacturing. It provides high-quality products that support scientists in research, biotechnology, diagnostics, and pharmaceuticals. Eurogentec has headquarters in Belgium and subsidiaries worldwide, employing over 320 people including more than 40 PhDs. Eurogentec has been a part of Kaneka Corporation, a large Japanese chemical company, since 2010.
Prosoft Clinical Services and Capabilities provides clinical trial services including CMC formulation development, biostatistics, data management, clinical operations, medical writing, and regulatory strategy and operations. They have experience across multiple therapeutic areas like allergy/respiratory, CNS, dermatology, heart failure, HIV, hypertension, oncology, pain, and women's health. Their team has extensive experience developing products through all phases of clinical trials and regulatory approval.
The document summarizes a sales meeting focused on taxane-related products, noting that taxanes require significant engineering for their formulation and that drugs like docetaxel and vinorelbine will become off-patent in the near future, presenting an opportunity. It provides details on companies developing lipid-soluble taxane products and clinical trials underway, and highlights a recent investigational new drug application filed for a novel liposomal docetaxel delivery system.
Thermo Fisher Scientific India Pvt. Ltd. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and approximately 55,000 employees globally. Our mission through our premier brands Thermo Scientific, Applied Bio Systems, Invitrogen, Fisher Scientific and Unity Lab Services, we offer an unmatched combination of innovative is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. We offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
ProGammaScience Corporation is a consulting firm based in Montreal that has been providing quality assurance, regulatory affairs, and technical operations services to the pharmaceutical industry since 1985, including assistance with submissions, GMP compliance, analytical method validation, product development, and technical training. The company aims to deliver excellent client service and documentation support at the best possible cost through its team of qualified professionals. Some of ProGammaScience's clients include major pharmaceutical companies like Abbott, AstraZeneca, Merck, Novartis, and Pfizer.
Diagenode is a privately held Belgian biotech company focused on developing and commercializing high-value epigenetics products for research and diagnostics. It has a strong reputation for expertise in sonication and leadership in epigenetics research. Diagenode has a market leadership position in epigenetics and offers innovative automated systems like the SX-8G IP-Star for chromatin immunoprecipitation and methylation assays, and the BioruptorNGS for next generation sequencing applications. The company aims to make epigenetics research more accessible, automated, and consistent through products like its sonication and automated platform technologies.
A smart enteral feeding system with integrated reflux monitoring and prevention. The system comprises of both proprietary hardware and software. A
feeding tube (LifeSafe Tube™) with embedded sensors collects data continuously. Proprietary algorithms analyze the collected data, weighing multiple risk factors such as patient position and physiological functions (ie: sneezing, coughing) to predict when reflux will occur. This information is used to automatically calibrate a feeding pump and optimize feeding rate in order to prevent reflux.
- Narvitas Medical Devices develops proprietary medical devices to improve laparoscopic and epidural procedures.
- Their first product, LapDome, provides safer and faster abdominal access during laparoscopic surgery compared to current Veress needle methods, addressing a $15 million market that is growing 8.3% annually.
- The management team has experience in medical device companies and regulatory approval processes. Financial projections estimate positive EBITDA by 2016 and growing profits through 2017 as the company expands into new markets.
QualiMedd is an independent UK-based consultancy established in 1990 that specializes in providing quality and regulatory services to medical device and in vitro diagnostic companies. They offer assistance with ISO certification, implementing quality systems, technical files, design dossiers, FDA and EU requirements. Their managing director Jim Mackenzie has over 35 years of experience in the medical industry. QualiMedd works with companies of all sizes to help ensure they meet international standards and directives.
1) Anteo Diagnostics will partner with Atomo Diagnostics to develop a rapid blood test for early detection of heart attacks using Anteo's coating technology and Atomo's AtomoRapid platform.
2) Atomo received $100,000 in funding from the Advance Queensland Johnson & Johnson Innovation QuickFire Challenge to create a proof of concept for their rapid heart attack test.
3) If the proof of concept is successful, Atomo and Anteo will consider fully commercializing an AtomoRapid-based cardiac troponin test, which could improve on current tests in the large and growing $350 million point-of-care cardiac biomarkers market.
Roger Rocha Placement Presentation AusDiagnostics.pptxRogerCoca
This document provides information about a laboratory technician placement opportunity at AusDiagnostics UK Ltd. for Roger Rocha, a BSc Biomedical Science student at Sheffield Hallam University. AusDiagnostics is an international biotechnology company that specializes in multiplex PCR diagnostic kits. The placement would involve tasks in laboratory maintenance, quality control, production assistance, and office administration to develop technical and professional skills. The document notes benefits such as experience in a fast-paced environment and opportunities for graduate roles or industry work.
Far Gene Pouyesh Iranian is an Iranian company established in 1996 that imports laboratory equipment for life sciences, nano-bio, and agro-food. It has over 30 employees across scientific, R&D, sales, administrative, financial, commercial, and technical departments. The company generates an annual turnover of $2.8 million and is headquartered in Tehran. Far Gene provides services including after-sales support, customer satisfaction assessments, equipment repairs and training. It works with overseas suppliers and has an agent in West Azerbaijan province. The company values integrity, employee well-being, superior customer service and long-term value.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Eldrug S.A is a biotechnology company established in 2007 and located in Patras, Greece that specializes in drug discovery and development. It has received over 6 million euros in funding from various sources including VIANEX S.A and the Greek Ministry of Development to develop peptides and peptide mimetics for clinical trials targeting conditions like multiple sclerosis and hypertension. Eldrug collaborates with various academic institutions and has won several awards for its innovative research projects.
Presentation given at the Garage Start Digital Health Startup Workshop sponsored by ABRT Venture Capital. Content focuses on the healthtech investment landscape.
TetraQ is a preclinical drug development facility located at the University of Queensland in Brisbane, Australia. It was founded in 2005 by four experts in the core areas of preclinical drug development - efficacy, ADME, toxicology, and pharmaceutics. TetraQ provides a range of preclinical services including efficacy testing in disease models, ADME/pharmacokinetic studies, toxicology testing, and formulation development to assess drug candidates and help reduce risks prior to clinical trials. The services help determine whether drug candidates are likely to be safe and effective enough to advance to human studies.
WerfenLife is a global healthcare company dedicated to research, development, manufacturing and distribution of specialized healthcare products. In 2015, WerfenLife achieved sales of 1.175 billion euros, a 14% increase over 2014. WerfenLife's key business divisions saw growth, with Werfen increasing 6.7% and Medical Devices and Distribution also experiencing gains. WerfenLife invested heavily in R&D and new facilities to drive innovation and growth. Looking ahead to 2016, WerfenLife expects continued positive trends and plans further investments in areas like R&D, commercial expansion and new facilities to maximize its leadership in specialized healthcare.
Alyante is a custom research services organisation that delivers quality research to help improve your research efficiencies. It provides comprehensive end-to-end solutions ranging from chemical and pharmaceutical development to product supply, including complete regulatory support for filing. To enhance your product portfolio, Alyante offers innovative services including NDDS.
Alyante’s array of innovation-based services and commitment to excellence will help you create new value.
Alyante is an assurance of an alliance that strives to keep your research always ahead of the competition through innovation and trust.
Easy Earnings Through Refer and Earn Apps Without KYC.pptxFx Lotus
Learn how to make extra money with refer and earn apps that don’t require KYC. Find out the advantages, top apps, and strategies to boost your earnings quickly and easily.
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Enhancing Adoption of AI in Agri-food: IntroductionCor Verdouw
Introduction to the Panel on: Pathways and Challenges: AI-Driven Technology in Agri-Food, AI4Food, University of Guelph
“Enhancing Adoption of AI in Agri-food: a Path Forward”, 18 June 2024
Adani Group Requests For Additional Land For Its Dharavi Redevelopment Projec...Adani case
It will bring about growth and development not only in Maharashtra but also in our country as a whole, which will experience prosperity. The project will also give the Adani Group an opportunity to rise above the controversies that have been ongoing since the Adani CBI Investigation.
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The Enigmatic Gemini: Unveiling the Dual Personalitiesmy Pandit
Explore the fascinating world of the Gemini Zodiac Sign, where duality reigns supreme. Discover the personality traits, important dates, and horoscope insights that define the ever-curious and communicative Gemini.
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The Key Summaries of Forum Gas 2024.pptxSampe Purba
The Gas Forum 2024 organized by SKKMIGAS, get latest insights From Government, Gas Producers, Infrastructures and Transportation Operator, Buyers, End Users and Gas Analyst
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