Guideline

The National Anti-Corruption Commission Thailand proceeds to anti-bribery through ISO 37001 amidst digital age

Retrieved on: 
Wednesday, March 13, 2024

BANGKOK, THAILAND - Media OutReach Newswire - 27 February 2024 - The Office of the National Anti-Corruption Commission (NACC) as the main agency for the prevention and suppression of corruption in Thailand, announced to seriously adopt ISO 37001 in tackling corruption, involving giving and receiving bribes in the current digitalization era. The NACC indicated that bribery problems are a serious threat and impact every nation around the world. It disrupts economic systems and creates challenges and obstacles for numerous nations. According to the World Bank, bribery accounts for as much as US$1 trillion annually, which is equivalent to 3% of the global GDP. As such, the ISO is both, an independent organization and a non-governmental international organization, whose mission is to establish international standards, therefore ISO 37001 Anti-Bribery Management System or ABMS has been developed by ISO. ISO 37001 is the international standard for a management system designed to prevent the giving and receiving of bribes. This anti-corruption management guideline is applicable to all types or sizes of organizations, including those in the public, private, and non-profit sectors. Each country can use it as guidance to adopt and voluntarily implement these standards domestically. The ISO 37001 is internationally recognized as an instrument for corporate compliance programs and as a powerful internal control measure to prevent bribery of juristic persons. Many countries have implemented domestic regulations to incentivize and promote the adoption of ISO 37001 in both the private and public sectors. The NACC has amended the Organic Act on Anti-Corruption, B.E. 2561 (2018) by including a provision that imposes criminal penalties for juristic person instances of bribery. This amendment has studied best practices from foreign countries and studied or adopted the principle of ISO 37001 into consideration in drafting Section 176 of the act as well, resulting in consistency with the principle and practice of ISO 37001. For the purpose of concrete mobilization and raising awareness of Section 176, the NACC has established the Anti-Bribery Advisory Service (ABAS) to drive anti-bribery concretely. ABAS is a center that collects and disseminates various knowledge as well as provides recommendations to prevent bribery problems in the business sectors. In this regard, the NACC provides "Guidelines on Appropriate Internal Control Measures for Juristic Persons", which align with ISO 37001. The guidelines and other interest documents can be downloaded via https://www.nacc.go.th/abas/ ---------- Source: https://www.nacc.go.th/categorydetail/20180831184638361/20240208140737 *This press release translation is funded by the National Anti-Corruption Fund (NACF). Hashtag: #IntegrityWay #AntiCorruption #ZeroCorruption #NACC #NACF

Key Points: 
  • As such, the ISO is both, an independent organization and a non-governmental international organization, whose mission is to establish international standards, therefore ISO 37001 Anti-Bribery Management System or ABMS has been developed by ISO.
  • ISO 37001 is the international standard for a management system designed to prevent the giving and receiving of bribes.
  • Many countries have implemented domestic regulations to incentivize and promote the adoption of ISO 37001 in both the private and public sectors.
  • In this regard, the NACC provides "Guidelines on Appropriate Internal Control Measures for Juristic Persons", which align with ISO 37001.

EQS-News: Schaeffler publishes Sustainability Report 2023

Retrieved on: 
Wednesday, March 13, 2024

With the publication of the Sustainability Report 2023, the company is not only creating transparency for its stakeholders but also highlighting its progress.

Key Points: 
  • With the publication of the Sustainability Report 2023, the company is not only creating transparency for its stakeholders but also highlighting its progress.
  • As Schaeffler CEO Klaus Rosenfeld comments: “Sustainability is an integral part of our corporate strategy.
  • As part of the Roadmap 2025, “Sustainability & Engagement” is the subprogram under which Schaeffler will ensure the consistent implementation of its sustainability strategy and the achievement of its sustainability goals.
  • The Schaeffler Group’s Sustainability Report provides information on the company’s key areas of focus in 2023 and on developments in key figures and objectives within the Schaeffler Group.

AB Science provides a summary of the live webcast held on March 4, 2024 giving an update on AB Science development

Retrieved on: 
Thursday, March 7, 2024

SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT

Key Points: 
  • SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT
    AB Science SA (Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on March 4, 2024, giving an update on AB Science development.
  • Regarding Health Canada, a Notice of Deficiency-Withdrawal (NOD/w) has been issued and AB Science intends to submit a Request for Reconsideration.
  • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.
  • AB Science will be free to continue the development of masitinib in SCD based on phase 2 data with biomarkers.

American Urological Association Releases Salvage Therapy for Prostate Cancer Guideline

Retrieved on: 
Thursday, February 29, 2024

BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.

Key Points: 
  • BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.
  • Understanding the evaluation and appropriate use of salvage therapies for patients with biochemical recurrence is a critical area of prostate cancer care.
  • “Thanks to the incredible expertise of the entire Panel, this guideline helps provide a roadmap that combines the latest advancements with thoughtful recommendations, empowering patients and clinicians alike.”
    This guideline has 30 recommendations and is a useful reference for effective evidence-based care related to salvage therapy for prostate cancer.
  • Salvage therapy for prostate cancer: AUA/ASTRO/SUO guideline part I: introduction and treatment decision-making at the time of suspected biochemical recurrence after radical prostatectomy.

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

Retrieved on: 
Tuesday, March 12, 2024

16

Key Points: 
    • 16

      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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      53

      12.

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

      66

      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

      72

      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,

      89

      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

      94

      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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      127

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

      128

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

    • 129

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

      130

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

      131

      substantially to the allergen products as discussed above.

    • 1

      156

      ?

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

      157
      158

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

      159
      160
      161

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

      ?

      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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      162

      ?

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

      163

      4.

    • In any

      199

      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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      200

      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

      291

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

      292

      intracutaneous or provocation testing.

    • 298

      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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      306

      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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      377

      8.

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

      378

      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

      376

      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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      415

      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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      454
      455

      8.2.1.

    • 493

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      527

      In general, sensitivity and specificity of the product should be determined.

    • 540

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

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      561

      10.2.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      595

      4.

    • Allergol Immunopathol, 1989;

      602

      17(2):53-65

      603

      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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Preliminary QIG Considerations regarding Pharmaceutical Process Models

Retrieved on: 
Tuesday, March 12, 2024

6

Key Points: 
    • 6

      Preliminary QIG Considerations regarding Pharmaceutical
      Process Models

      7

      Background

      8

      This Quality Innovation Group (QIG) document follows on from the first QIG Listen & Learn Focus

      9

      Group (LLFG) on Continuous manufacturing and the second QIG LLFG on Digital novel technologies,

      5

      10

      held on 13 March 2023 and 12-13 October 2023 respectively.

    • 12

      It is recognised that regulatory expectations for process models in pharmaceutical manufacturing are

      13

      evolving; the intent of this document is to share QIG?s current thinking with stakeholders and seek

      14

      their comments.

    • This, in turn, supports adoption of advanced process

      25

      control strategies, continuous process verification, real-time process monitoring and optimisation, and

      26

      automated or even autonomous operation and management of manufacturing processes.

    • Process

      27

      models play an increasingly important role in process design and validation, in control strategies and

      28

      during manufacturing process lifecycle.

    • The expected outcome from the use of process models is

      29

      enhanced process understanding, (multivariate) monitoring and control, robustness, performance and

      30

      adaptability.

    • 31

      A model (in the context of pharmaceutical manufacturing) is a mathematical representation of a

      32

      physical or biological process or system.

    • Empirical models (e.g., multivariate models used for Statistical Process Control, regression models

      39

      derived from data collected from Design of Experiments), and

      40

      3.

    • 45

      Scope

      46

      This document addresses preliminary considerations (general principles) for process models, reflecting

      47

      the use of performance-based approaches in pharmaceutical manufacturing processes.

    • 48

      The scope of this document is limited to process models such as first-principle models, regression

      49

      models, system models, multivariate statistical process control models, and Machine Learning models

      50

      (ML).

    • Complex datasets need not be
      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      113

      submitted.

    • 137

      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      151

      Of note, these are just examples.

    • Process validation for finished products ? information and data to be provided in regulatory submissions
      (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1)
      Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory
      submission (EMA/CHMP/BWP/187338/2014)
      4
      5

      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      163

      Some models may have a dual purpose e.g., used for process development and used as part of the

      164

      control strategy e.g., to set control limits.

    • 200

      Process validation (as described in the process validation guidelines) has an overarching role to ensure

      201

      that the process consistently delivers material of the intended quality.

    • Depending on the model risk, a model verification protocol may be requested,
      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

      Page 6/7

      209

      including the model performance metrics and the manufacturing process IPC and CQAs that should be

      210

      followed, the respective acceptance criteria, the number of additional data (independent) that would be

      211

      used, and the monitoring period (parallel testing).

    • Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

      Page 7/7

ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

Retrieved on: 
Tuesday, March 12, 2024

The completed comments form should be sent to

Key Points: 
    • The completed comments form should be sent to
      [email protected]
      *For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
      to align with ICH E2D(R1) guideline.
    • 18
      July 2003

      E2D

      Approval by the Steering Committee under Step 4 and
      recommendation for adoption to the three ICH
      regulatory bodies.

    • 12
      November 2003

      New
      Codification
      November
      2005
      E2D

      E2D

      Revision of E2D
      Code

      History

      E2D(R1) Endorsement by the Members of the ICH Assembly
      under Step 2 and release for public consultation.

    • Date

      New
      Codification

      5 February 2024

      E2D(R1)

      POST-APPROVAL SAFETY DATA:
      DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
      REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
      E2D(R1)
      ICH Consensus Guideline
      Table of Contents
      1.

    • The ICH E2D guideline provides guidance on definitions and standards for post-

      5

      approval individual case safety reporting, as well as good case management practices.

    • Detailed guidance on the

      9

      specific structure, format, standards, and data elements for transmitting Individual Case Safety

      10

      Reports (ICSRs) is provided in the ICH E2B guideline.

    • Guidance on periodic reporting of

      11

      aggregated safety data is covered in the ICH E2C guideline.

    • 12

      This guideline provides recommendations that are harmonised to the extent possible given

      13

      differences in post-market safety reporting requirements among ICH regions.

    • 25

      2.1.2

      Adverse Drug Reaction (ADR)

      26

      Adverse drug reactions, as defined by local and regional requirements, concern noxious and

      27

      unintended responses to a medicinal product.

    • 66

      Product labelling may include information related to ADRs for the pharmaceutical class to

      67

      which the medicinal product belongs.

    • In some cases, ?other observations? can occur

      78

      without any associated AEs/ADRs, while in other cases ?other observations? can occur with

      79

      an associated AE/ADR.

    • 84

      For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

      85

      regions refer to AEs.

    • 86

      Refer to local and regional requirements for specifications and requirements on the reporting

      87

      of AEs or ADRs to each Regulatory Authority.

    • 89

      2.2

      90

      An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific

      91

      point of time.

    • Cases missing any of the above criteria do not qualify for reporting; due diligence

      99

      should be exercised to collect the missing criteria.

    • 6

      104

      An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,

      105

      Other Observations), or both.

    • Primary sources, often referred

      112

      to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

      113

      to the MAH or regulatory authority.

    • 127

      2.7

      128

      A digital platform is the software and technology used to enable transmission of information

      129

      between users (see Section 4.3, Digital Platforms).

    • Expedited Report

      Primary Source

      Healthcare Professional (HCP)

      Consumer

      Digital Platform

      7

      130

      2.8

      131

      An organised data collection system (ODCS) is an activity that gathers data in a planned manner,

      132

      thereby enabling review to be performed.

    • MAHs should also follow the

      286

      advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

      13

      287

      regulatory authorities.

    • MAHs may conduct an MRP

      395

      using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be

      396

      selected.

    • 564

      Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately

      565

      reflected in appropriate ICH E2B data elements.

    • 638

      Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

      639

      pharmacovigilance data, as duplicates negatively impact signal detection.

    • 651

      Duplicate detection relies on good quality data and is generally based on similarities but should

      652

      take into account that information in ICSRs may differ between reporters.

QuidelOrtho Receives Health Canada Approval for Quidel® Triage® PLGF Test for Laboratory Use in Canada

Retrieved on: 
Wednesday, March 6, 2024

QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada.
  • The Triage PLGF test is a fluorescence immunoassay to be used with the small footprint Triage MeterPro® Instrument for the quantitative determination of placental growth factor (“PLGF”) in maternal plasma specimens.
  • With the Triage PLGF test, clinicians can be positioned to better detect angiogenic imbalance and assess the risk for these complications.
  • The Triage PLGF test is available to customers in Canada for use with the Triage MeterPro instrument.

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance

Retrieved on: 
Monday, February 26, 2024

HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.

Key Points: 
  • HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.
  • The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.
  • “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH.
  • There were also zero cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.

CAP Updates Validation of Immunohistochemical Assays Testing Guideline for Precise Results, Improved Patient Care

Retrieved on: 
Friday, February 23, 2024

The College of American Pathologists (CAP) updated the “Principles of Analytic Validation of Immunohistochemical Assays” guideline to provide increased precision and accuracy of clinical immunohistochemical assays.

Key Points: 
  • The College of American Pathologists (CAP) updated the “Principles of Analytic Validation of Immunohistochemical Assays” guideline to provide increased precision and accuracy of clinical immunohistochemical assays.
  • This update assesses evidence published since the release of the original guideline in 2014 and provides new recommendations on how to analytically validate/verify immunohistochemical assays used for diagnostic and predictive purposes.
  • “This updated guideline provides new and revised recommendations for analytic validation/verification of immunohistochemical assays, which often guide therapeutic decision making for cancer treatment,” explains guideline chair, Jeffrey D. Goldsmith, MD, FCAP.
  • Current tools, resources, and information for the Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update can be found on the guideline webpage on cap.org.