Applicant (sketch)

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

Retrieved on: 
Tuesday, March 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

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      Table of contents

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

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      1.

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

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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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      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.

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      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
      in moderate to low-sized study populations
      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.

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      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
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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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.

    • 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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      8.2.1.

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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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      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
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      10.2.

    • 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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      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
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6

Retrieved on: 
Sunday, March 10, 2024

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Key Points: 
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      Committee for Veterinary Medicinal Products (CVMP)

      Procedural advice on the accelerated assessment of
      marketing authorisation applications pursuant to Article
      44 (3) of Regulation (EU) No 2019/6

      Table of contents
      1.

    • Accelerated assessment of the marketing authorisation application ....... 5
      6.1.
    • It only applies to marketing authorisation applications and does not cover any postauthorisation procedure.
    • The document replaces the ?Guideline on the procedure for accelerated
      assessment pursuant to Article 39(8) of Regulation (EC) No 726/2004' (EMEA/CVMP/32995/2006).
    • General considerations
      The accelerated assessment procedure is applicable to marketing authorisation applications for
      veterinary medicinal products falling within the scope of Article 44(3) of Regulation (EU) 2019/6.
    • An accelerated assessment request has to be agreed by the CVMP before submission of
      a marketing authorisation application as it introduces changes in the operation of the CVMP and
      procedure timelines.
    • A
      decision on accelerated assessment will be taken without prejudice to the (future) CVMP opinion
      (positive or negative) on the granting of a marketing authorisation.
    • It forms the basis for requesting an accelerated assessment and should be
      followed unless otherwise justified.
    • Procedural advice on the accelerated assessment of marketing authorisation
      applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
      EMA/CVMP/32995/2006 ? Rev.2

      Page 3/8

      5.3.

    • Request for an accelerated assessment procedure
      The formal request for an accelerated assessment should be submitted approximately 3-2 months prior
      to the actual submission of the marketing authorisation application.
    • Applicants are also reminded that evaluation under accelerated assessment is subject to
      the same evidence requirements for marketing authorisation as an evaluation under standard
      timetable.
    • Procedural advice on the accelerated assessment of marketing authorisation
      applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
      EMA/CVMP/32995/2006 ? Rev.2

      Page 5/8

      6.2.

    • ** The timing of the documents should be at least 11 working days in advance of the CVMP plenary meeting

      Procedural advice on the accelerated assessment of marketing authorisation
      applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
      EMA/CVMP/32995/2006 ? Rev.2

      Page 6/8

      7.2.

    • Procedural advice on the accelerated assessment of marketing authorisation
      applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
      EMA/CVMP/32995/2006 ? Rev.2

      Page 8/8

Comeet, a Spark Hire Company, Launches One-Way Video Interviewing within ATS Workflow: Access Better Hiring for Everyone

Retrieved on: 
Thursday, February 22, 2024

This exciting rollout introduces Spark Hire's one-way video interviewing feature directly into its ATS platform marking a significant stride toward better hiring for everyone.

Key Points: 
  • This exciting rollout introduces Spark Hire's one-way video interviewing feature directly into its ATS platform marking a significant stride toward better hiring for everyone.
  • This new feature is designed to transform the hiring process, making it more efficient, automated, flexible, and accessible for recruiters, hiring teams, and candidates alike.
  • In celebration of this product advancement, Spark Hire and Comeet are providing an exclusive offer for its Comeet ATS users: 25 complimentary one-way video interviews each month.
  • "This new feature is just a glimpse into the incredible Talent Acquisition Suite that we're building at Spark Hire," said Josh Tolan, CEO of Spark Hire.

Applicant Tracking Systems Market to grow by USD 745.21 million from 2022 to 2027, The advantages of applicant tracking systems to boost growth - Technavio

Retrieved on: 
Tuesday, February 6, 2024

NEW YORK, Feb. 6, 2024 /PRNewswire/ -- The applicant tracking systems market is estimated to grow by USD 745.21 million from 2022 to 2027, according to Technavio.

Key Points: 
  • NEW YORK, Feb. 6, 2024 /PRNewswire/ -- The applicant tracking systems market is estimated to grow by USD 745.21 million from 2022 to 2027, according to Technavio.
  • By geography, the global applicant tracking systems market is segmented into North America, Europe, APAC, Middle East and Africa, and South America.
  • What are the key data covered in this Applicant Tracking Systems Market report?
  • The recruitment process outsourcing market is estimated to grow by USD 7,600.36 million at a CAGR of 15.2% between 2022 and 2027.

Modern HR Software Solutions Introduce New Features to Enhance Workplace Efficiency in 2024

Retrieved on: 
Tuesday, January 30, 2024

MIAMI, Jan. 30, 2024 /PRNewswire/ -- With the New Year underway, many businesses are reevaluating their HR software solutions to increase efficiency and effectiveness in the evolving HR management landscape. Gartner data highlights that businesses frequently replace HR software due to system inefficiencies, missing features, and reliability concerns. Key reasons for dissatisfaction include inefficiency (34%), insufficient functionality (29%), and unreliability (13%).

Key Points: 
  • MIAMI, Jan. 30, 2024 /PRNewswire/ -- With the New Year underway, many businesses are reevaluating their HR software solutions to increase efficiency and effectiveness in the evolving HR management landscape.
  • Gartner data highlights that businesses frequently replace HR software due to system inefficiencies, missing features, and reliability concerns.
  • In response to these challenges, modern HR software solutions are offering five new features designed to enhance efficiency within its software:
    AI-powered Applicant Tracking System : New AI-powered Applicant Tracking System (ATS) to streamline the traditional CV screening process, a major bottleneck in recruitment.
  • Recognizing this, Factorial , a leading provider of HR software solutions, is introducing innovative features from AI-powered applicant tracking to payroll integration.

Indeed Introduces Specialist Media Networks, Helping Employers Reach More Skilled Professionals Across Industry-Specific Sites to Hire for Hard-to-Fill Roles

Retrieved on: 
Tuesday, January 16, 2024

Indeed , a leading global hiring platform and a subsidiary of Recruit Holdings , today introduced Specialist Media Networks to help employers hire for competitive and hard-to-fill roles.

Key Points: 
  • Indeed , a leading global hiring platform and a subsidiary of Recruit Holdings , today introduced Specialist Media Networks to help employers hire for competitive and hard-to-fill roles.
  • Indeed’s Specialist Media Networks are designed to better support employers hiring for hard-to-fill roles.
  • By opting into a network when sponsoring a job on Indeed, employers can reach more skilled professionals in a competitive hiring landscape.
  • These new solutions come on the heels of several AI-powered products recently announced to help employers hire simpler and faster.

Human medicines European public assessment report (EPAR): Skyclarys, Omaveloxolone, Status: Opinion

Retrieved on: 
Tuesday, January 2, 2024

The active substance of Skyclarys is omaveloxolone (ATC code: not yet assigned).

Key Points: 
  • The active substance of Skyclarys is omaveloxolone (ATC code: not yet assigned).
  • Omaveloxolone activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway which is involved in the cellular response to oxidative stress.
  • The full indication is:
    Skyclarys is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
  • Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Government Open Data Management Platform Market to grow by USD 96.48 million from 2023 to 2028 | Process optimization and operational efficiency drives the market - Technavio

Retrieved on: 
Tuesday, December 19, 2023

The potential growth difference for the government open data management platform market between 2023 and 2028 is USD 96.48 million.

Key Points: 
  • The potential growth difference for the government open data management platform market between 2023 and 2028 is USD 96.48 million.
  • These concerns can create obstacles to the adoption and use of open data management platforms, which can negatively impact the growth of the government market for open data management (ODM) platforms.
  • At the core of the Government Open Data Management Platform market lies robust data management and governance frameworks.
  • Key Companies in the Government Open Data Management Platform Market:
    The autonomous cars software market size is estimated to grow at a CAGR of 39.04% between 2023 and 2028.

Stryten Energy Named a 2024 Military Friendly Employer

Retrieved on: 
Saturday, November 11, 2023

Alpharetta, Georgia, Nov. 11, 2023 (GLOBE NEWSWIRE) -- Stryten Energy has been named a 2024 Gold Military Friendly® Employer in the annual list from militaryfriendly.com , which recognizes companies that create sustainable and meaningful career paths, community outreach, brand enthusiasm and enduring partnerships that benefit the military community.

Key Points: 
  • Alpharetta, Georgia, Nov. 11, 2023 (GLOBE NEWSWIRE) -- Stryten Energy has been named a 2024 Gold Military Friendly® Employer in the annual list from militaryfriendly.com , which recognizes companies that create sustainable and meaningful career paths, community outreach, brand enthusiasm and enduring partnerships that benefit the military community.
  • Stryten Energy hires military members across every level of the company from the executive management team to the plant floor, with many having progressed through the company via multiple promotions.
  • Methodology, criteria and weightings were determined by VIQTORY with input from the Military Friendly ® Advisory Council of independent leaders in the military recruitment community.
  • “We will always be committed to hiring members of the military community and making them an integral part of our Stryten Energy team,” said Judd.

Missouri School District Selects PowerSchool to Simplify and Modernize Hiring Process

Retrieved on: 
Thursday, December 7, 2023

PowerSchool (NYSE: PWSC), the leading provider of cloud-based software for K-12 education in North America, today announced Carthage R-9 School District in Carthage, Missouri selected PowerSchool Applicant Tracking , part of the Educator Recruitment Cloud , as its new K-12 applicant software.

Key Points: 
  • PowerSchool (NYSE: PWSC), the leading provider of cloud-based software for K-12 education in North America, today announced Carthage R-9 School District in Carthage, Missouri selected PowerSchool Applicant Tracking , part of the Educator Recruitment Cloud , as its new K-12 applicant software.
  • Once Applicant Tracking is fully implemented, Carthage R-9 will be able to navigate the hiring process quickly and more easily.
  • “Adding Applicant Tracking is a welcome improvement for our district because our hiring supervisors will now be able to screen candidates much quicker,” said Matt Arnold, Director of Human Resources, Carthage R-9 School District.
  • It also provides an enhanced experience for job seekers, with smooth communication and scheduling features, which ensure a more professional hiring process with less friction.