Documentation

Top US Bank, Commerce goes live with loan origination on Temenos banking platform

Retrieved on: 
Tuesday, February 20, 2024

NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Temenos (SIX: TEMN), today announced that Commerce Bank, a top US bank, has gone live with Temenos’ (Infinity) loan origination solution , increasing operational efficiency and delivering a frictionless, hyper-personalized customer experience.

Key Points: 
  • NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Temenos (SIX: TEMN), today announced that Commerce Bank, a top US bank, has gone live with Temenos’ (Infinity) loan origination solution , increasing operational efficiency and delivering a frictionless, hyper-personalized customer experience.
  • In 2022, the bank migrated over 2.5 million customers and 6.9 million accounts to the Temenos platform.
  • Temenos (Infinity) Loan Origination offers powerful decisioning, highly customizable applications, dynamic features, and extensive third-party integrations.
  • With Temenos (Infinity) Loan Origination, Commerce has been able to automate the process with increased digitization to eliminate paper processes, improve reliability and drive end-to-end product origination process down to 5 minutes or less.

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: 
    • 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

      Page 2/18

      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

      Page 3/18

      88

      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

      Page 4/18

      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

      Page 5/18

      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

      Page 6/18

      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

      Page 9/18

      305
      306

      7.1.

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

      Page 11/18

      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

      Page 12/18

      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

      Page 13/18

      454
      455

      8.2.1.

    • 493

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

      Page 15/18

      527

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

    • 540

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

      Page 16/18

      561

      10.2.

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

      Page 17/18

      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

      Page 18/18

Preliminary QIG Considerations regarding Pharmaceutical Process Models

Retrieved on: 
Tuesday, March 12, 2024

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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

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      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

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      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

      Page 3/7

      113

      submitted.

    • 137

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

      Page 4/7

      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

      Page 5/7

      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

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      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

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      an associated AE/ADR.

    • 84

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

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      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

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      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.

apexanalytix Transforms Supplier Management with Generative AI Platform

Retrieved on: 
Thursday, March 7, 2024

Today, apexanalytix , the leading provider of global supply chain risk management data, software and services, announces the launch of apex Neural Engine, an AI-powered solution poised to shape the future of the supplier management landscape.

Key Points: 
  • Today, apexanalytix , the leading provider of global supply chain risk management data, software and services, announces the launch of apex Neural Engine, an AI-powered solution poised to shape the future of the supplier management landscape.
  • The rise of large language models (LLMs) like ChatGPT has deeply impacted the supplier management space, with 50% of supply chain leaders actively planning to deploy generative AI in the next twelve months.
  • While off-the-shelf AI solutions can offer convenience, they also come with a unique set of challenges and limitations.
  • With the release of apex Neural Engine, apexanalytix aims to streamline supplier interactions, improve communication, and ultimately contribute to more robust risk management strategies so organizations can navigate the complex supplier landscape with confidence.

KBRA Assigns Preliminary Ratings to Freddie Mac’s STACR 2024-HQA1

Retrieved on: 
Thursday, March 7, 2024

KBRA assigns preliminary ratings to 24 classes from Freddie Mac Structured Agency Credit Risk (STACR®) REMIC 2024-HQA1 Notes, Freddie Mac STACR REMIC Trust 2024-HQA1 (STACR 2024-HQA1), a credit risk sharing transaction with a total note offering of $712,000,000.

Key Points: 
  • KBRA assigns preliminary ratings to 24 classes from Freddie Mac Structured Agency Credit Risk (STACR®) REMIC 2024-HQA1 Notes, Freddie Mac STACR REMIC Trust 2024-HQA1 (STACR 2024-HQA1), a credit risk sharing transaction with a total note offering of $712,000,000.
  • STACR 2024-HQA1 features loans with loan-to value (LTV) ratios greater than 80%, but less than or equal to 97%.
  • The Offered Notes represent obligations of the STACR 2024-HQA1 Trust in a credit-linked note structure governed by a credit protection agreement between the trust and Freddie Mac, with payments subject to the credit and principal payment risks of the STACR 2024-HQA1 Reference Pool.
  • The STACR 2024-HQA1 Reference Pool consists of 69,295 residential mortgage loans with an outstanding principal balance of approximately $23.1 billion as of the cut-off date.

ASI Holdco, LLC Enters into a Letter of Intent to Sell a Majority Stake in Ashley Stewart, Inc.

Retrieved on: 
Thursday, March 7, 2024

ASI Holdco, LLC, the parent company of Ashley Stewart, Inc. (“Ashley Stewart”), the leading fashion retailer of apparel, intimates, and accessories for women sizes 10 to 36, announced today that it has entered into a Letter of Intent (“LOI”) with Kinbow LLC.

Key Points: 
  • ASI Holdco, LLC, the parent company of Ashley Stewart, Inc. (“Ashley Stewart”), the leading fashion retailer of apparel, intimates, and accessories for women sizes 10 to 36, announced today that it has entered into a Letter of Intent (“LOI”) with Kinbow LLC.
  • (“Kinbow”), to sell Kinbow a majority stake in Ashley Stewart.
  • According to the LOI, Kinbow plans to purchase a majority of the stock of Ashley Stewart and to continue to operate all of Ashley Stewart’s brick-and-mortar stores and ecommerce business in their current form.
  • Commenting on their prospective acquisition of a majority stake in Ashley Stewart, Ram Ajjarapu, Executive Director of Kinbow, said, “We are excited about the opportunity to partner with this iconic retailer.

2600Hz Wins 2024 TMCnet Awards for Internet Telephony Product of the Year and Remote Work Pioneer

Retrieved on: 
Thursday, March 7, 2024

Ooma, Inc. , a smart communications platform for businesses and consumers, today announced that 2600Hz, an Ooma company, has won the 2024 TMCnet awards for Internet Telephony Product of the Year and Remote Work Pioneer.

Key Points: 
  • Ooma, Inc. , a smart communications platform for businesses and consumers, today announced that 2600Hz, an Ooma company, has won the 2024 TMCnet awards for Internet Telephony Product of the Year and Remote Work Pioneer.
  • 2600Hz won the TMCnet Internet Telephony Product of the Year Award for new offerings within its cloud call center offering and won the TMCnet Remote Work Pioneer Award for adding In-Browser Deployment to its comm.land unified communications users portal.
  • “I am honored to recognize 2600Hz with the 2024 Internet Telephony Product of the Year Award and the 2024 Remote Work Pioneer Award for its commitment to excellence and innovation,” said Rich Tehrani , CEO, TMC.
  • “We very much appreciate these awards from TMCnet that recognize the value of our continuing innovation.”

Automotive-Compliant, Three-Channel, Linear LED Driver from Diodes Incorporated Provides Independent Controls for Brightness and Color

Retrieved on: 
Wednesday, March 6, 2024

Diodes Incorporated (Diodes) (Nasdaq: DIOD) today releases a new automotive-compliant* linear LED driver that enables users to independently control the brightness and color of its three channels.

Key Points: 
  • Diodes Incorporated (Diodes) (Nasdaq: DIOD) today releases a new automotive-compliant* linear LED driver that enables users to independently control the brightness and color of its three channels.
  • Human-centric automotive design is driving the demand for multi-channel LED drivers, which allow vehicle occupants to easily change interior lighting colors to match their mood.
  • By simultaneously enabling animated turning-indicator signals and exterior grill lighting for different road conditions, these drivers help increase safety levels.
  • The AL1783Q driver has LED current settings by an external REF pin, independent dimming controls for each channel, and pulse width modulation (PWM) to perform LED dimming.

Legal Services Pricing Platform Demonstrates the Need for Clear Fee Structuring Amid EU Commission and Qualcomm Fee Dispute - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 6, 2024

The recent legal dispute between Qualcomm and the European Commission, which saw the EU Commission contest Qualcomm’s legal fee claim of over €12 million, highlights the critical need for transparency and specificity in legal fee documentation.

Key Points: 
  • The recent legal dispute between Qualcomm and the European Commission, which saw the EU Commission contest Qualcomm’s legal fee claim of over €12 million, highlights the critical need for transparency and specificity in legal fee documentation.
  • This case underscores the necessity of clear, detailed documentation to support fee requests, an area where the Legal Services Pricing Platform excels.
  • As we move forward, the Legal Services Pricing Platform remains dedicated to enhancing the transparency and efficiency of legal fee management.
  • For more information on how the Legal Services Pricing Platform can transform your legal fee negotiations and strategy, visit Legal Services Pricing Platform