IO

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

Oxford BioTherapeutics Announces Launch of Enhanced Discovery Platform, OGAP®-Verify, at World ADC Conference 2024

Retrieved on: 
Thursday, March 7, 2024
OBT, Membrane, IO, Messenger, Therapeutic index, Spacecraft, Drug discovery, ADC, Conference, Proteomics, Chemistry, Toxicity, Partner, Patient, Protein, Science, Annual, Benchmarking, Tissue, Vaccine

“I am delighted to announce major technological advances with the launch of OBT’s OGAP-Verify target discovery platform.

Key Points: 
  • “I am delighted to announce major technological advances with the launch of OBT’s OGAP-Verify target discovery platform.
  • OGAP-verify is now more sensitive than IHC and allows for enhanced sensitivity with improved target selection, solving some of the challenges in antibody specificity,” said Christian Rohlff, CEO, Oxford BioTherapeutics.
  • “OBT is dedicated to discovering and validating the next generation of ADC targets for safe and effective medicines.
  • OBT is a Partner of the Annual World ADC Conference 2024 in London, UK.

IO Biotech Announces Acceptance of Abstract to be Presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Wednesday, March 6, 2024
IO, TME, AACR, Vaccine, IDO1, Patient, Poster, PD-L1

NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that an abstract has been accepted for presentation at the American Association for Cancer Research Annual Meeting 2024 (AACR 2024), taking place April 5-10, 2024 in San Diego, CA.

Key Points: 
  • NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that an abstract has been accepted for presentation at the American Association for Cancer Research Annual Meeting 2024 (AACR 2024), taking place April 5-10, 2024 in San Diego, CA.
  • The poster will include nonclinical data related to IO Biotech’s lead therapeutic cancer vaccine candidate, IO102-IO103, currently being evaluated in a pivotal Phase 3 study.
  • “We are excited with our new nonclinical data clearly demonstrating how the dual antigen vaccine IO102-IO103 differentially contribute to the anti-tumor effect: while IO102 treatment results in the reduction of the immune suppression in the TME, IO103 appears to impact by enhancement of T effector function,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech.
  • “These findings further support the potential that co-administration of the dual antigen vaccine IO102-IO103 can benefit patients due to its impact on two separate immune resistance pathways, IDO1 and PD-L1, respectively.”

Lantern Pharma's A.I. Platform, RADR®, Surpasses 60 Billion Data Points – Anticipates Reaching 100 Billion Data Points in 2024, Paving the Way for Enhanced Cancer Therapy Innovations and Expedited Development Timelines

Retrieved on: 
Monday, March 4, 2024
Health, Pharmaceutical, Technology, Artificial Intelligence, Oncology, Collection, IO, Multimedia, FDA, Data collection, Growth, Drug development, Drug discovery, ADC, IPO, Attention, Patient, 2000s, Machine learning, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240304409919/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240304409919/en/
    “Every data point we add to RADR® further advances our goal of building the most complete, largest, and most powerful AI platform for oncology drug development.
  • “RADR® has now surpassed 60 billion data points, making innovation in developing cancer therapies potentially more precise, powerful, and comprehensive.
  • Additionally, we continue to automate key areas of the growth in our data collection and curation, leading us to have more successful and larger data expansion campaigns.
  • While studying the impact of compounds and therapeutic combinations previously took years, RADR® has reduced many aspects of this process to mere months.

KBRA Assigns Preliminary Ratings to J.P. Morgan Mortgage Trust 2024-HE1 (JPMMT 2024-HE1)

Retrieved on: 
Monday, February 26, 2024
Finance, Data Analytics, Professional Services, Other Professional Services, Insurance, United Wholesale Mortgage, FOCUS, KBRA, RMBS, IO, Telescopic sight

KBRA assigns preliminary ratings to 7 classes of Mortgage Participation Pass-Through Certificates from J.P. Morgan Mortgage Trust 2024-HE1 (JPMMT 2024-HE1), a $210.0 million RMBS transaction sponsored by J.P. Morgan Mortgage Acquisition Corp. and FOCUS III Advisory, LLC.

Key Points: 
  • KBRA assigns preliminary ratings to 7 classes of Mortgage Participation Pass-Through Certificates from J.P. Morgan Mortgage Trust 2024-HE1 (JPMMT 2024-HE1), a $210.0 million RMBS transaction sponsored by J.P. Morgan Mortgage Acquisition Corp. and FOCUS III Advisory, LLC.
  • The transaction consists entirely of second lien home equity lines of credit (HELOCs).
  • The underlying pool is seasoned approximately two months and comprises 2,800 loans, with United Wholesale Mortgage, LLC (51.5%) and loanDepot.com, LLC (39.8%) representing the largest contributing originators.
  • Most of the loans feature 20-year repayment periods after initial draw windows of three or ten years.

Intel CEO Pat Gelsinger Receives 2024 Distinguished Executive Leadership Award from JEDEC Board

Retrieved on: 
Wednesday, February 21, 2024
Internet, Hardware, Electronic Design Automation, Consumer Electronics, Technology, Semiconductor, Mobile, Wireless, Other Technology, IO, Multimedia, USB, Electronics, I486, Distinguishing, Management

The JEDEC® Board of Directors presented its prestigious 2024 Distinguished Executive Leadership Award to Intel CEO, Pat Gelsinger, in a ceremony held at Intel’s offices in Santa Clara, CA earlier this month.

Key Points: 
  • The JEDEC® Board of Directors presented its prestigious 2024 Distinguished Executive Leadership Award to Intel CEO, Pat Gelsinger, in a ceremony held at Intel’s offices in Santa Clara, CA earlier this month.
  • This award stands as JEDEC’s highest honor and recognizes the most distinguished senior executives in the electronics industry who promote and support the advancement of JEDEC standards.
  • View the full release here: https://www.businesswire.com/news/home/20240221972203/en/
    JEDEC Board members George Vergis (left), Belal Gharaibeh and Chairman Mian Quddus present Pat Gelsinger, Intel CEO, with the association's Distinguished Executive Leadership Award for 2024.
  • Under his leadership, Intel has made a tremendous impact on many groundbreaking memory and IO technologies in JEDEC,” said Mian Quddus, JEDEC Board of Directors Chairman.

Renesas Develops Embedded MRAM Macro that Achieves over 200MHz Fast Random-Read Access and a 10.4 MB/s Fast Write Throughput for High Performance MCUs

Retrieved on: 
Wednesday, February 21, 2024
Electronic Design Automation, Semiconductor, Data Management, Technology, Nanotechnology, Hardware, Bias, OTP, International, MB, Cascode, IO, STT-MRAM, ISSCC, AI, Multimedia, Megabit, Temperature, Renesas Electronics, Internet of things, VLSI, Conference, Memory, MCU, EFuse, Hertz, CPU, Computer data storage

It achieves a random read access frequency of over 200 MHz and a write throughput of 10.4-megabytes-per-second (MB/s).

Key Points: 
  • It achieves a random read access frequency of over 200 MHz and a write throughput of 10.4-megabytes-per-second (MB/s).
  • View the full release here: https://www.businesswire.com/news/home/20240221234586/en/
    Renesas test chip with breakthrough fast write and fast read technology.
  • As IoT and AI technologies continue to advance, MCUs used in endpoint devices are expected to deliver higher performance than ever.
  • To address these challenges, Renesas has developed the following new circuit technologies to achieve faster read and write operations in MRAM.

Supermicro Accelerates Performance of 5G and Telco Cloud Workloads with New and Expanded Portfolio of Infrastructure Solutions

Retrieved on: 
Monday, February 26, 2024
Cloud, Gigabit Ethernet, ARM, Generative, RAN, TB, LLM, 2U, A40, AS, A10, Central processing unit, Fujitsu, PCI Express, 3D, MWC, CPU, MIMO, Vodafone, Memory, AMD, Synchronous Ethernet, NEBS, A2, SAN, Total, IO, DDR5, Building block, Service, NVIDIA, Mobile World Congress, EPYC, Intel, AI, GNSS, Temperature, Samsung, Synthetic media, COTS, Graphics processing unit, H100, Video game

SAN JOSE, Calif., and BARCELONA, Spain, Feb. 26, 2024 /PRNewswire/ -- Supermicro, Inc. (NASDAQ: SMCI), a Total IT Solution Provider for AI, Cloud, Storage, and 5G/Edge, delivers an expanded portfolio of purpose-built infrastructure solutions to accelerate performance and increase efficiency in 5G and telecom workloads. With one of the industry's most diverse offerings, Supermicro enables customers to expand public and private 5G infrastructures with improved performance per watt and support for new and innovative AI applications. As a long-term advocate of open networking platforms and a member of the O-RAN Alliance, Supermicro's portfolio incorporates systems featuring 5th Gen Intel® Xeon® processors, AMD EPYC™ 8004 Series processors, and the NVIDIA Grace Hopper™ Superchip.

Key Points: 
  • "Supermicro is expanding our broad portfolio of sustainable and state-of-the-art servers to address the demanding requirements of 5G and telco markets and Edge AI," said Charles Liang, president and CEO of Supermicro.
  • Our products enable operators to offer new capabilities to their customers with improved performance and lower energy consumption.
  • The platform's versatility empowers our customers to adapt our solutions to their specific needs, giving them control over their infrastructure.
  • Supermicro will demonstrate a wide range of solutions for the 5G and telco markets at MWC Barcelona 2024.

Supermicro Accelerates Performance of 5G and Telco Cloud Workloads with New and Expanded Portfolio of Infrastructure Solutions

Retrieved on: 
Monday, February 26, 2024
Cloud, Gigabit Ethernet, ARM, Generative, RAN, TB, LLM, 2U, A40, AS, A10, Central processing unit, Fujitsu, PCI Express, 3D, MWC, CPU, MIMO, Vodafone, Memory, AMD, Synchronous Ethernet, NEBS, A2, SAN, Total, IO, DDR5, Building block, Service, NVIDIA, Mobile World Congress, EPYC, Intel, AI, GNSS, Temperature, Samsung, Synthetic media, COTS, Graphics processing unit, H100, Video game

SAN JOSE, Calif., and BARCELONA, Spain, Feb. 26, 2024 /PRNewswire/ -- Supermicro, Inc. (NASDAQ: SMCI), a Total IT Solution Provider for AI, Cloud, Storage, and 5G/Edge, delivers an expanded portfolio of purpose-built infrastructure solutions to accelerate performance and increase efficiency in 5G and telecom workloads. With one of the industry's most diverse offerings, Supermicro enables customers to expand public and private 5G infrastructures with improved performance per watt and support for new and innovative AI applications. As a long-term advocate of open networking platforms and a member of the O-RAN Alliance, Supermicro's portfolio incorporates systems featuring 5th Gen Intel® Xeon® processors, AMD EPYC™ 8004 Series processors, and the NVIDIA Grace Hopper™ Superchip.

Key Points: 
  • "Supermicro is expanding our broad portfolio of sustainable and state-of-the-art servers to address the demanding requirements of 5G and telco markets and Edge AI," said Charles Liang, president and CEO of Supermicro.
  • Our products enable operators to offer new capabilities to their customers with improved performance and lower energy consumption.
  • The platform's versatility empowers our customers to adapt our solutions to their specific needs, giving them control over their infrastructure.
  • Supermicro will demonstrate a wide range of solutions for the 5G and telco markets at MWC Barcelona 2024.

Global Digital Oilfield Market to reach a valuation of US$ 70.1 billion by 2034, FMI Projection

Retrieved on: 
Wednesday, February 21, 2024
Robotics, Algorithm, IO, Weatherford International, Integrated operations, Internet of things, CGG, Growth, ABB, Rockwell Automation, Schlumberger, Safety, Collaboration, FMI, Cloud computing, VR, Workforce, Software, Pet industry

NEWARK, Del., Feb. 21, 2024 /PRNewswire/ -- The global digital oilfield market is anticipated to reach a valuation of US$ 34.1 Billion in 2024, driven by integration of blockchain technology.

Key Points: 
  • NEWARK, Del., Feb. 21, 2024 /PRNewswire/ -- The global digital oilfield market is anticipated to reach a valuation of US$ 34.1 Billion in 2024, driven by integration of blockchain technology.
  • Collaboration and partnerships among oil and gas companies, technology providers, and service vendors are driving innovation and accelerating the adoption of digital oilfield solutions.
  • Prominent players in the digital oilfield market are Schlumberger, Halliburton, Weatherford International, ABB, Emerson, CGG, Siemens, Rockwell Automation, and Kongsberg, among others.
  • Future Market Insights offers an unbiased analysis of the global digital oilfield market, providing historical data for 2019 to 2023 and forecast statistics from 2024 to 2034.