GxP

PLEZi NUTRITION LAUNCHES PLEZi FiZZ TO TAKE ON SODAS AND SUGARY DRINKS

Retrieved on: 
Tuesday, March 12, 2024
Kitchen, Health, FoodCorps, Nutrient, Entrepreneurship, Amazon, Potassium, Caregiver, Vegetable, White, Partnership, Family medicine, Public, Milk, Human, University, Food, Parenting, Kitchen Cabinet, Sugar, GxP, Pediatrics, Drink, Water, Mother, Snack, Movement, Parent, Drinking water, Soft drink

WASHINGTON, March 12, 2024 /PRNewswire/ -- PLEZi Nutrition, the Public Benefit Company co-founded by former First Lady Michelle Obama on a mission to create higher standards for how the U.S. makes and markets food and beverages for kids, announced today at Expo West the launch of PLEZi FiZZ. A carbonated fruit drink that will be available this spring in three new flavors, PLEZi FiZZ builds upon the company's inaugural product, PLEZi, and aims to reach an older demographic of tweens and teens.

Key Points: 
  • Sugar-sweetened beverages, also referred to as sugary drinks, are the leading source of added sugars for kids, which is why PLEZi Nutrition chose to start with a focus on beverages.
  • In addition to reducing sugar and sweetness, they are adding in nutrients kids need, all with the aim to replace sugary drinks and snacks.
  • I'm thrilled to build on those efforts through PLEZi Nutrition as we work to drive change throughout the entire food and beverage industry."
  • Building upon a $1 million commitment to FoodCorps' Nourishing Futures initiative, PLEZi Nutrition will be investing 10% of profits right back into the broader movement to promote kids' health.

Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

Retrieved on: 
Wednesday, April 3, 2024
Community, Reproduction, Appendix, European Medicines Agency, Patient, Parliament, MAH, Council, Member state, European, NCA, GxP, Legislation, Communication, Comment, Classification, Partnership, Risk, Committee, PSMF, Safety, Calendar, CHMP, State, Documentation, Public, Directive 2001/83/EC, IWG, GVP, Commission, CAPA, Guideline, IO, Computer, PRAC, European Parliament, Registry, Record, Peer review, Language, Collection, Inspection

Union procedure on the preparation, conduct and

Key Points: 
    • Union procedure on the preparation, conduct and
      reporting of EU pharmacovigilance inspections
      Table of contents
      1.
    • Record management and archiving ....................................................................... 12

      References ................................................................................................ 12
      Appendix 1 ?Pharmacovigilance inspection report .................................... 13
      Appendix 2- Inspection overview (IO) ...................................................... 14
      Appendix 3- Pharmacovigilance inspection outcome sharing .................... 15
      Appendix 4- Classification of inspection findings....................................... 16

      Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 2/16

      1.

    • Guidelines on the interpretation of legislative pharmacovigilance
      requirements are published in the adopted good pharmacovigilance practices (GVPs) Module III ?
      pharmacovigilance inspections.
    • Preparation of a risk-based programme for pharmacovigilance inspections is presented in the Union
      procedure on the coordination of EU pharmacovigilance inspections.
    • Scope
      This procedure constitutes a guideline in preparing, conducting and reporting national competent
      authority (NCA) pharmacovigilance inspections and outlines the steps taken of the Committee for
      Medicinal Products for Human Use (CHMP) requested pharmacovigilance inspections.
    • Those are covered under the Union procedure on the
      management of pharmacovigilance inspection findings which may impact the robustness of the benefitrisk profile of the concerned medicinal products.
    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 3/16

      3.

    • Preparation
      Preparation encompasses those activities undertaken after the selection of an MAH, or third party, for
      a pharmacovigilance inspection and prior to inspection conduct.
    • For the selection of involved
      parties for CHMP requested inspections, refer to the Union procedure on the coordination of EU
      pharmacovigilance inspections.
    • Announcement communications could include, for example, the

      Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 4/16

      name of the inspector(s), MAH, the objectives and nature of the inspection (i.e.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 5/16

      ?

      Feedback from other competent authority functions, in particular pharmacovigilance assessors.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 6/16

      ?

      If teleconference(s) are planned during the inspection with experts, assessors, MAH personnel
      located off site etc.

    • ?

      Union procedure on the management of pharmacovigilance inspection findings which may impact
      the robustness of the benefit-risk profile of the concerned medicinal products.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 12/16

      Appendix 1 ?Pharmacovigilance inspection report
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 13/16

      Appendix 2- Inspection overview (IO)
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 14/16

      Appendix 3- Pharmacovigilance inspection outcome sharing
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 16/16

Box Expands its Collaboration with Microsoft with New Azure OpenAI Service Integration

Retrieved on: 
Tuesday, March 5, 2024
Security, Technology, Software, Networks, Artificial Intelligence, Internet, Cloud, Social media, AI, Public sector, Microsoft Graph, Assistant, Marketing, GxP, Microsoft PowerPoint, Microsoft Azure, First officer (aviation), Intranet, FINRA, Organization, Policy, Microsoft Excel, Clinical trial, Privacy, FedRAMP, Microsoft, Research

Box, Inc. (NYSE: BOX), the leading Content Cloud, today announced a new integration with Microsoft Azure OpenAI Service to bring its advanced large language models to Box AI.

Key Points: 
  • Box, Inc. (NYSE: BOX), the leading Content Cloud, today announced a new integration with Microsoft Azure OpenAI Service to bring its advanced large language models to Box AI.
  • By integrating with Azure OpenAI Service, Box is applying the most advanced intelligence models to its Content Cloud to further advance enterprise-grade AI.
  • “We are excited to see Box leveraging the power of Microsoft Azure OpenAI Service to further enhance the Box Content Cloud.
  • Copilot: Box will also soon integrate with Microsoft Copilot for Microsoft 365 starting in Teams via the Box connector for Microsoft Graph.

Signant Health Unveils Next-Level Advancements in Efficient, Compliant IP Management with Updates to its Clinical Supply Solutions

Retrieved on: 
Wednesday, March 6, 2024
Clinical trial, IP, Health, GxP, Risk, Warehouse

PHILADELPHIA, March 6, 2024 /PRNewswire/ -- Signant Health , the leader in evidence generation for modern clinical trials, announced today the release of key enhancements to its clinical supply management solutions, Signant SmartSignals® GxP Inventory and Signant SmartSignals® RTSM.

Key Points: 
  • PHILADELPHIA, March 6, 2024 /PRNewswire/ -- Signant Health , the leader in evidence generation for modern clinical trials, announced today the release of key enhancements to its clinical supply management solutions, Signant SmartSignals® GxP Inventory and Signant SmartSignals® RTSM.
  • Clinical research sponsors use these solutions to streamline investigational product (IP) and enterprise-wide supply chain management.
  • At the core of the enhancements are functionality updates that provide integration capabilities for improved efficiency, visibility, and compliance across a study or program.
  • For more information on Signant Health's clinical and enterprise supply chain management solutions, please visit https://www.signanthealth.com/solutions/ip-management/ .

Signant Health Unveils Next-Level Advancements in Efficient, Compliant IP Management with Updates to its Clinical Supply Solutions

Retrieved on: 
Wednesday, March 6, 2024
Clinical trial, IP, Health, GxP, Risk, Warehouse

PHILADELPHIA, March 6, 2024 /PRNewswire/ -- Signant Health , the leader in evidence generation for modern clinical trials, announced today the release of key enhancements to its clinical supply management solutions, Signant SmartSignals® GxP Inventory and Signant SmartSignals® RTSM.

Key Points: 
  • PHILADELPHIA, March 6, 2024 /PRNewswire/ -- Signant Health , the leader in evidence generation for modern clinical trials, announced today the release of key enhancements to its clinical supply management solutions, Signant SmartSignals® GxP Inventory and Signant SmartSignals® RTSM.
  • Clinical research sponsors use these solutions to streamline investigational product (IP) and enterprise-wide supply chain management.
  • At the core of the enhancements are functionality updates that provide integration capabilities for improved efficiency, visibility, and compliance across a study or program.
  • For more information on Signant Health's clinical and enterprise supply chain management solutions, please visit https://www.signanthealth.com/solutions/ip-management/ .

Launch of Ground-Breaking "Toward Good Simulation Practice" Book to Set New Standards in Biomedical Simulation

Retrieved on: 
Monday, March 4, 2024
Laboratory, FDA, GxP, Use, Methodology, Springer Nature, Computation, University, Engineering, Medicine, Patient safety, Device, Computer simulation, Partnership, Medical device

CM&S is also a very promising technology into the broader narrative of advancing regulatory science and healthcare innovation.

Key Points: 
  • CM&S is also a very promising technology into the broader narrative of advancing regulatory science and healthcare innovation.
  • The book underscores the necessity for guidelines akin to the GxP standards, yet specifically tailored for in silico methodologies.
  • It leverages the ASMEV&V40 – 2018 standard as a model, proposing a consensus-driven framework to support CM&S with good practices applicable across the spectrum of medical solutions.
  • This partnership illustrates the proactive engagement between regulatory agencies and the scientific community to foster advancements in medical product development.

Launch of Ground-Breaking "Toward Good Simulation Practice" Book to Set New Standards in Biomedical Simulation

Retrieved on: 
Monday, March 4, 2024
Laboratory, FDA, GxP, Use, Methodology, Springer Nature, Computation, University, Engineering, Medicine, Patient safety, Device, Computer simulation, Partnership, Medical device

CM&S is also a very promising technology into the broader narrative of advancing regulatory science and healthcare innovation.

Key Points: 
  • CM&S is also a very promising technology into the broader narrative of advancing regulatory science and healthcare innovation.
  • The book underscores the necessity for guidelines akin to the GxP standards, yet specifically tailored for in silico methodologies.
  • It leverages the ASMEV&V40 – 2018 standard as a model, proposing a consensus-driven framework to support CM&S with good practices applicable across the spectrum of medical solutions.
  • This partnership illustrates the proactive engagement between regulatory agencies and the scientific community to foster advancements in medical product development.

Pariveda Achieves B Corp™ Certification, Reinforcing Its Commitment to Purpose-Driven Business

Retrieved on: 
Monday, March 4, 2024
Woman, B Lab, B Corporation (certification), Certification, Organization, Movement, GxP, Environment, Management

DALLAS, March 4, 2024 /PRNewswire/ -- Pariveda, a leading consulting firm dedicated to solving complex business challenges, is proud to announce its certification as a B Corporation™ (B Corp). This certification marks a significant milestone in Pariveda's journey and demonstrates that it meets high standards of positive impact that reach far beyond its walls to include all stakeholders — workers, communities, customers, and the planet.

Key Points: 
  • Consulting leader Pariveda joins the global B Corp community, emphasizing its people-first approach and dedication to using business as a force for good™.
  • DALLAS, March 4, 2024 /PRNewswire/ -- Pariveda, a leading consulting firm dedicated to solving complex business challenges, is proud to announce its certification as a B Corporation™ (B Corp).
  • This certification invites the world to see how doing business for good is possible, no matter the size," said Margaret Rogers, CEO at Pariveda.
  • Pariveda will monitor its performance against the B Corp standards, which is a dynamic process of continuous improvement.

Europe Industrial Robotics Market Set to Double by 2030, Driven by Automation and Smart Technologies

Retrieved on: 
Thursday, February 29, 2024
Carbon footprint, Welding, Growth, Electronics, Government, Food, European, GxP, Automation, Plastic, Agriculture, Table tennis rubber, GBP, Cartesian, Robotics, Human, Environment, SCARA, 3D printing

The Europe industrial robotics market is expected to grow from US$ 4.5 billion in 2022 to US$ 9.87 billion by 2030.

Key Points: 
  • The Europe industrial robotics market is expected to grow from US$ 4.5 billion in 2022 to US$ 9.87 billion by 2030.
  • The Europe industrial robotics market is segmented into Germany, France, the UK, Italy, Spain, Sweden, Belgium, the Netherlands, and the Rest of Europe.
  • Thus, the growing government support to boost automation will further boost the growth of the Europe industrial robotics market.
  • Based on country, the Europe industrial robotics market is segmented into Germany, France, Italy, Spain, the UK, Sweden, Belgium, Netherlands, and the Rest of Europe.

Kohler Co. Showcases Innovation in Design Leadership and Wellness at KBIS 2024

Retrieved on: 
Monday, February 26, 2024
Quartz, Acquisition, Filtration, Collection, GxP, Light, Statuesque, Steam, Qingming Festival, Kitchen, Microbubble, Cinq, EPA WaterSense, Calendar, Wave, Kohler Co., Water, KBIS, EPA, Lighting, Vitreous china, Partnership

Guests are encouraged to explore all the latest products throughout the impressive space with a focus on color and design leadership, sustainable living, and wellness.

Key Points: 
  • Guests are encouraged to explore all the latest products throughout the impressive space with a focus on color and design leadership, sustainable living, and wellness.
  • For more than 150 years, Kohler has built a legacy of design leadership through innovation and craftmanship.
  • Wellness brand Sprig by Kohler amplifies the bathing experience, offering clean aromatherapy that infuses the space with soothing botanicals.
  • To learn more about Kohler Co. brands and products, please visit the Kohler KBIS Press Kit.