Sentinel surveillance

Ginkgo Bioworks and the Public Health Center of the Ukraine Ministry of Health Announce Collaboration to Implement Biosecurity Capabilities in Ukraine

Retrieved on: 
Tuesday, January 17, 2023
Ginkgo Bioworks, Ginkgo, Uncertainty, COVID-19, Infection, Public health, Biosecurity, Severe acute respiratory syndrome coronavirus 2, DNA, Risk, NYSE, U.S. Army Public Health Center, KYIV, Partnership, Sentinel surveillance, Concentric objects, Organization, Vaccine, Health

BOSTON and KYIV, Ukraine, Jan. 17, 2023 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, and the Public Health Center of the Ukraine Ministry of Health today announced a new collaboration to conduct a wastewater testing pilot program in Ukraine with the intent to help provide early warning for infectious disease outbreaks and enable rapid and strategic public health intervention.

Key Points: 
  • Amidst the ongoing COVID-19 pandemic and the strain on health infrastructure in Ukraine due to the war, the risk of infectious diseases spreading in the country has increased.
  • Through this partnership, Ginkgo is building upon the large-scale pathogen monitoring platform developed by its biosecurity and public health unit, Concentric by Ginkgo, to implement a nimble, on-the-ground biosecurity program for monitoring of biological threats found in critical wastewater systems.
  • The program can be utilized to address biosecurity gaps during acute moments of crisis, where public health infrastructure has been affected by adverse circumstances.
  • "We are grateful to be able to partner with the Public Health Center of the Ukraine Ministry of Health to implement this novel response program and provide critical data to help public health leaders make well-informed decisions."

Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022)

Retrieved on: 
Monday, July 11, 2022
Mars, Competence, EU, FDA, Compliance, Sentinel surveillance, MDR, CAPA, Complaint, Medical device, Vigilance

Key goal of this course is to understand:

Key Points: 
  • Key goal of this course is to understand:
    Legal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Regulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Implementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recalls
    What to do when a complaint is received:
    Implementing interactive systems between complaint handling, medical device reporting, and CAPA
    Submission of MDR's to the FDA:
    Submission of Vigilance Reports to EU Competent Authorities:
    What to do when a medical device needs to be recalled:
    To discussion of key case studies and how to prevent compliance issues related to Complaint Management, MDR, Vigilance reporting and medical device product recalls
    Anyone that participates in product complaint management, medical device reporting, vigilance reporting, and/or product recalls:

Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 28, 2022
Medical Devices, Health, Sentinel surveillance, CAPA, Complaint, FDA, Competence, Mars, EU, MDR, Compliance, Medical device, Vigilance

Key goal of this course is to understand:

Key Points: 
  • Key goal of this course is to understand:
    Legal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Regulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
    Implementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recalls
    What to do when a complaint is received:
    Implementing interactive systems between complaint handling, medical device reporting, and CAPA
    Submission of MDR's to the FDA:
    Submission of Vigilance Reports to EU Competent Authorities:
    What to do when a medical device needs to be recalled:
    To discussion of key case studies and how to prevent compliance issues related to Complaint Management, MDR, Vigilance reporting and medical device product recalls
    Anyone that participates in product complaint management, medical device reporting, vigilance reporting, and/or product recalls:

Introduction to the In-Vitro Diagnostic Regulation (IVDR) Online Training Course (November 3-4, 2022) - ResearchAndMarkets.com

Retrieved on: 
Monday, May 16, 2022
Biotechnology, Medical Devices, Health, Science, Research, PMS, Risk management, Sentinel surveillance, IVD, TGA, FDA, Industry, Peter Consterdine, Compliance, MDSAP, Health Canada, UDI, Medical device, EU

She has over 30 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex II list products.

Key Points: 
  • She has over 30 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex II list products.
  • Also identifying regulatory strategies around global submissions (EU, FDA, Health Canada, TGA, Russia, Latin America and China).
  • He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
  • We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Global Real-World Evidence (RWE) Solutions Markets, 2021-2028 - Focus on Market Access, Oncology, Neurology, Post Market Surveillance in Pharma Companies & Providers - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 11, 2022
Real-World Evidence, Health, Biotechnology, European Climate Assessment and Dataset, Neurology, Epidemiology, Adoption, Growth, Component, Solution, Pharma, Integration, Drug recall, Drug development, Sentinel surveillance, RWE, Compliance, Hospital, Drug discovery, Investment, Medical device, Pharmacy, Oncology

The "Real-World Evidence (RWE) Solutions Market by Component (Datasets [Clinical, Claims, Pharmacy, Integrated], Services), Application (Market Access, Oncology, Neurology, Post Market Surveillance), End User (Pharma Companies, Providers) - Global Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Real-World Evidence (RWE) Solutions Market by Component (Datasets [Clinical, Claims, Pharmacy, Integrated], Services), Application (Market Access, Oncology, Neurology, Post Market Surveillance), End User (Pharma Companies, Providers) - Global Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.
  • Rapidly growing big data in healthcare, shift from volume to value-based care, and rising focus towards personalized healthcare are the key factors driving the growth of the global RWE solutions market.
  • Based on application, the drug development & approvals segment is expected to witness the fastest growth rate during the forecast period.
  • North America is expected to command the largest share of the global RWE solutions market in 2021, followed by Asia-Pacific and Europe.

Rimsys Closes $16 Million Series A Financing Led by Bessemer Venture Partners

Retrieved on: 
Thursday, December 2, 2021
Data Management, Medical Devices, Health, Technology, Software, General Health, Patient, Omron, Sentinel surveillance, Automation, Consultant, Technology, IVDR, Philips, Time, European Union, Industry, DocuSign, Fiverr, Chief executive officer, Medtech, Compliance, Pinterest, Johnson & Johnson, Foundation, UDI, Thermo Fisher Scientific, MedTech Europe, Lung compliance, RIM, Research, Risk, The Cooper Companies, Initial public offering, Bessemer Venture Partners, Efficiency, Partner, NW Innovation Works, FDA, Union, Nunes memo, Yelp, Maintenance, LinkedIn, Siemens Healthineers, Growth, PagerDuty, MDR, Medical device, Rimsys, Bessemer Venture Partners, RIMSYS, BESSEMER VENTURE PARTNERS

Rimsys, the leading provider of Regulatory Information Management (RIM) software for the medtech industry, today announced it closed $16 million in Series A financing led by Bessemer Venture Partners, with participation from existing investors Allos Ventures, Private Opportunities, and Innovation Works.

Key Points: 
  • Rimsys, the leading provider of Regulatory Information Management (RIM) software for the medtech industry, today announced it closed $16 million in Series A financing led by Bessemer Venture Partners, with participation from existing investors Allos Ventures, Private Opportunities, and Innovation Works.
  • When I led regulatory affairs teams, we were always behind, said James Gianoutsos, Founder and President of Rimsys.
  • We are thrilled to partner with Rimsys and support their long-term success, said Andrew Hedin, Partner at Bessemer Venture Partners.
  • Bessemer has teams of investors and partners located in Tel Aviv, Silicon Valley, San Francisco, New York, London, Boston, Beijing and Bangalore.