Applicant (sketch)

POSaBIT Announces Anticipated Late Filing of the First Quarter Interim Filings

Retrieved on: 
星期四, 五月 30, 2024

POSaBIT Systems Corporation (CSE: PBIT, OTC: POSAF) (the "Company" or "POSaBIT"), announces today that the Company is anticipating a delay in filing its interim financial statements and accompanying management's discussion and analysis for the three months ended March 31, 2024 (the "Q1 Interim Filings"), by the filing deadline on May 30, 2024 (the "Filing Deadline"), as required by National Instrument 51-102 – Continuous Disclosure Obligations.

Key Points: 
  • POSaBIT Systems Corporation (CSE: PBIT, OTC: POSAF) (the "Company" or "POSaBIT"), announces today that the Company is anticipating a delay in filing its interim financial statements and accompanying management's discussion and analysis for the three months ended March 31, 2024 (the "Q1 Interim Filings"), by the filing deadline on May 30, 2024 (the "Filing Deadline"), as required by National Instrument 51-102 – Continuous Disclosure Obligations.
  • The reason for the anticipated delay of the filing of the Q1 Interim Filings is because the Company’s late filing of its annual financials did not allow sufficient time for completion of Q1 Interim Filings by the Filing Deadline.
  • The Applicant anticipates being able to file the Q1 Interim Filings on or before June 13, 2024.
  • The MCTO will stay in effect until the Q1 Interim Filings are filed.

DCHFA Extends the Deadline of the Fourth Annual Todd A. Lee Scholarship and Expands the Range of Majors Eligible for at Least $5,000 in Awards

Retrieved on: 
星期三, 五月 29, 2024

The scholarship is now open to 10 qualifying majors and can result in awards of at least $5,000.

Key Points: 
  • The scholarship is now open to 10 qualifying majors and can result in awards of at least $5,000.
  • We attract, educate, and develop the future leaders of tomorrow through our scholarship and internship programs.
  • The applicant must be matriculating in a Bachelor’s or Master’s of Science or Arts program at an accredited four-year university.
  • In Honor of Todd A. Lee
    Todd A. Lee was the Executive Director and CEO of DCHFA from 2016 to 2020.

Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence

Retrieved on: 
星期二, 五月 28, 2024

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Key Points: 
    • 11

      Reflection paper on use of real-world data in noninterventional studies to generate real-world evidence

      12

      Table of contents

      13

      1.

    • References ............................................................................................ 15

      10

      Reflection paper on use of real-world data in non-interventional studies to generate
      real-world evidence
      EMA/CHMP/150527/2024

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      1.

    • Introduction

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      This reflection paper discusses methodological aspects of non-interventional studies (NIS) using real-

      46

      world data (RWD) in order to generate real-world evidence (RWE) for regulatory purposes.

    • These include absence of randomisation, uncontrolled conditions, non-

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      standardised treatments and uncertainties regarding data quality and completeness.

    • The

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      increasing ability to capture electronic healthcare data and data from registries is now providing new

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      opportunities to use RWD and generate RWE that reflects clinical practice.

    • Scope

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      The scope of this reflection paper is the design, conduct and analysis of NIS using RWD to generate

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      RWE for regulatory purposes.

    • data collected specifically for the study in

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      question, or secondary use of existing data sources.

    • In both cases, attention should be paid to the

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      possible selection mechanisms in the data collection, for example the inclusion of specific patients or

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      the collection of specific clinical data.

    • Reference to studies with causal objectives in this document does not

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      imply an expectation that specific analytical methods will be used.

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      real-world evidence
      EMA/CHMP/150527/2024

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      The legal obligations and regulatory requirements applicable to NIS should be followed.

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      Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of

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      personal data and on the free movement of such data.

    • The specific aim of the study forms the basis for the

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      selection of data source(s), study design, and analysis approach.

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      real-world evidence
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      4.2.

    • Reflection paper on use of real-world data in non-interventional studies to generate
      real-world evidence
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      Regional differences in clinical practice and healthcare systems management, e.g.

    • Misclassification can arise at many different

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      steps of data collection and extraction: diagnosis, coding, recording, data transformation, data

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      aggregation, summarisation, and analysis.

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      real-world evidence
      EMA/CHMP/150527/2024

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      6.4.

    • For these studies, the study protocol should describe:

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      ?

      The data elements used to link the data.

    • Heterogeneity

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      In multi-database studies, different estimates may be found even when the same protocol is applied

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      across all data sources (22).

    • (2023)
      Reflection paper on use of real-world data in non-interventional studies to generate
      real-world evidence
      EMA/CHMP/150527/2024

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      570

      15.

    • Draft guidance Real-World Data: Assessing Electronic Health Records and Medical Claims
      Data To Support Regulatory Decision-Making for Drug and Biological Products (2021)

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      572
      573

      16.

    • Reflection paper on use of real-world data in non-interventional studies to generate
      real-world evidence
      EMA/CHMP/150527/2024

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Critical Research Expands into Healthcare Sector with Enhanced Background Screening Solutions and Strategic New Hire

Retrieved on: 
星期四, 五月 9, 2024

ATLANTA, May 9, 2024 /PRNewswire-PRWeb/ -- Critical Research is further solidifying its commitment to growth by appointing Rebecca Williamson as its new Sales Executive. Rebecca brings a wealth of experience to the role, having achieved a proven track record of success in the background screening industry at InformData.

Key Points: 
  • Critical Research, a leading provider of FCRA-compliant pre-employment background check solutions, is pleased to announce a strategic expansion into new markets, including the healthcare sector.
  • ATLANTA, May 9, 2024 /PRNewswire-PRWeb/ -- Critical Research is further solidifying its commitment to growth by appointing Rebecca Williamson as its new Sales Executive.
  • Leveraging her extensive knowledge and industry relationships, Rebecca will spearhead Critical Research's expansion into new markets, including a focus on the healthcare sector.
  • "We are thrilled to welcome Rebecca to the Critical Research team," said Andrea Griffin, Executive Vice President of Critical Research.

DCHFA Announces the Fourth Annual Todd A. Lee Scholarship for the Next Generation of Affordable Housing Leaders

Retrieved on: 
星期四, 四月 25, 2024

Washington, D.C., April 25, 2024 (GLOBE NEWSWIRE) -- The District of Columbia Housing Finance Agency (DCHFA) has launched the 2024 Todd A. Lee Scholarship.

Key Points: 
  • Washington, D.C., April 25, 2024 (GLOBE NEWSWIRE) -- The District of Columbia Housing Finance Agency (DCHFA) has launched the 2024 Todd A. Lee Scholarship.
  • He came to DCHFA to create an impact in the city through the preservation and construction of affordable and workforce housing in the District of Columbia.
  • As an extension of the Lee Legacy, DCHFA launched the scholarship in 2020 for students who aspire to have a career in the field of affordable housing.
  • Through the Todd A. Lee Scholarship, we are witnessing his continued influence and legacy via the scholarship recipients.

HiBob Introduces an Integrated Applicant Tracking System for Strategic Hiring

Retrieved on: 
星期二, 四月 16, 2024

NEW YORK and LONDON, April 16, 2024 /PRNewswire/ -- HiBob today unveils Bob Hiring, a fully integrated Applicant Tracking System (ATS) that connects candidate, employee, and business data for better decision-making. Bob Hiring intuitively links Bob Workforce Planning with the recruitment process, aligning hiring plans to dynamic business goals for an optimized process using a powerful, all-in-one HCM platform.

Key Points: 
  • A powerful system that seamlessly integrates best-in-class talent acquisition into your larger HR platform, enabling smarter hiring strategies that fuel business performance
    NEW YORK and LONDON, April 16, 2024 /PRNewswire/ -- HiBob today unveils Bob Hiring, a fully integrated Applicant Tracking System (ATS) that connects candidate, employee, and business data for better decision-making.
  • Bob Hiring intuitively links Bob Workforce Planning with the recruitment process, aligning hiring plans to dynamic business goals for an optimized process using a powerful, all-in-one HCM platform.
  • "HiBob has developed an easy-to-use and highly scalable recruiting system," says Josh Bersin, Founder and CEO of the Josh Bersin Company.
  • "As this application is integrated into HiBob, companies now have a candidate-centric talent acquisition system that's seamlessly integrated into all their other management processes."

AkkenCloud and HireGains Forge Powerful Partnership to Revolutionize Talent Acquisition

Retrieved on: 
星期二, 四月 9, 2024

NASHUA, N.H., April 9, 2024 /PRNewswire-PRWeb/ -- AkkenCloud, renowned for its commitment to redefining staffing simplicity and pioneering advanced automation and AI solutions for Staffing Industry, are delighted to announce a strategic partnership with HireGains. HireGains provides data-driven insights to determine an individual's fit to a particular role and a particular team within a staffing client's organization. Going beyond skills and experience this allows companies to match individuals who can enhance the overall performance of their work teams.

Key Points: 
  • "By combining our strengths in staffing management with HireGains' expertise in talent acquisition, we are empowering organizations to optimize their recruitment processes, attract top talent, and drive business growth" said Giridhar Akkineni, CEO at AkkenCloud.
  • "We are thrilled to embark on this strategic partnership with HireGains," said Giridhar Akkineni, CEO at AkkenCloud.
  • "By combining our strengths in staffing management with HireGains' expertise in talent acquisition, we are empowering organizations to optimize their recruitment processes, attract top talent, and drive business growth."
  • For more information about AkkenCloud and HireGains partnership and integrated solution, please visit www.akkencloud.com and https://www.hiregains.com/

WorkLLama Unveils Integrated ATS Driven With AI, Revolutionizing Talent Engagement

Retrieved on: 
星期二, 三月 19, 2024

This cutting-edge enhancement is designed to provide WorkLLama customers with a fully integrated technology solution, ensuring best-in-class customer and candidate experiences.

Key Points: 
  • This cutting-edge enhancement is designed to provide WorkLLama customers with a fully integrated technology solution, ensuring best-in-class customer and candidate experiences.
  • The introduction of the ATS into WorkLLama's single, AI-driven platform marks a significant milestone in the company's mission to optimize and scale talent marketing, recruitment, talent relationship management, and shift scheduling.
  • "We are excited to offer our customers this revolutionary ATS, which represents a major step forward in our mission to provide a total talent sourcing and engagement platform," said Sudhakar Maruvada, CEO of WorkLLama.
  • We believe that this will set a new standard in the industry for what technology can achieve in talent acquisition."

WorkLLama Unveils Integrated ATS Driven With AI, Revolutionizing Talent Engagement

Retrieved on: 
星期二, 三月 19, 2024

This cutting-edge enhancement is designed to provide WorkLLama customers with a fully integrated technology solution, ensuring best-in-class customer and candidate experiences.

Key Points: 
  • This cutting-edge enhancement is designed to provide WorkLLama customers with a fully integrated technology solution, ensuring best-in-class customer and candidate experiences.
  • The introduction of the ATS into WorkLLama's single, AI-driven platform marks a significant milestone in the company's mission to optimize and scale talent marketing, recruitment, talent relationship management, and shift scheduling.
  • "We are excited to offer our customers this revolutionary ATS, which represents a major step forward in our mission to provide a total talent sourcing and engagement platform," said Sudhakar Maruvada, CEO of WorkLLama.
  • We believe that this will set a new standard in the industry for what technology can achieve in talent acquisition."

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
星期二, 三月 12, 2024

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Key Points: 
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      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

      17

      Table of contents

      18

      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
      15

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

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      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

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      considerations for allergen products within the scope of the guideline.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
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      EMA/CHMP/72790/2024

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

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      quality and clinical development according to the current knowledge.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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      conditions will require separate clinical trials (see Section 6).

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      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

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      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

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      substantially to the allergen products as discussed above.

    • 1

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      Guideline on the clinical development of products for specific immunotherapy for the treatment

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      of allergic diseases - CHMP/EWP/18504/2006
      ?

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      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

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      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

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      case, a reduced validation should include all relevant manufacturing process steps that are considered
      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      product specific.

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      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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      intracutaneous or provocation testing.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
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      7.1.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

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      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

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      8.2.1.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      In general, sensitivity and specificity of the product should be determined.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
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      10.2.

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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
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