International Council

Sustainable Aviation Fuel Market Report 2024-2024: Government Initiatives Are Pushing the Adoption of Sustainable Aviation Fuel (SAF) - ResearchAndMarkets.com

Retrieved on: 
fredag, maj 31, 2024
Oil, Gas, Sustainability, Environment, Energy, Air, Aerospace, Transport, Manufacturing, Ester, International Council, International, Aviation, ICCT, Aviation biofuel, Carbon, Dicarboxylic acid, Sugar, SAF, EIC, Jet fuel

World revenue for the Sustainable Aviation Fuel Market is forecast to surpass US$ 1.46 billion in 2024.

Key Points: 
  • World revenue for the Sustainable Aviation Fuel Market is forecast to surpass US$ 1.46 billion in 2024.
  • A key challenge impeding the Sustainable Aviation Fuel (SAF) market growth is the limited availability and high cost of sustainable feedstocks.
  • Where is the sustainable aviation fuel market heading and how can you ensure you are at the forefront of the market?
  • Discover qualitative analyses (including market dynamics, drivers, opportunities, restraints and challenges), cost structure, impact of rising sustainable aviation fuel prices and recent developments.

Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling

Retrieved on: 
tisdag, maj 28, 2024
Fertility, PBPK, International Council, Toxicity, Marketing, Risk, Birth, Medication package insert, Clinical trial, Vaccination, NOAEL, Woman, Causality, Lactation, Interest, Teratology, Health care, IMI, Human, Reproduction, GVP, Harmonization, Technical, Communication, SWP, Risk assessment, Committee, PCWP, Literature, Female, Health, PRAC, QRD, Safety, Animal, Breast milk, Bibliography, PPP, Child, Toxicology, Sample size determination, Patient, North American Menopause Society, Conception, DSM-IV codes, Medication, Innovation, Pregnancy, Medicine, EMA, ICH, Knowledge, DART, European Medicines Agency, CHMP, Birth control

13

Key Points: 
    • 13
      Keywords

      Pregnancy, breastfeeding, lactation, fertility, reproductive toxicity,
      teratogenicity, contraindication, clinical assessment, non-clinical
      assessment, risk assessment, labelling, Summary of Product Characteristics
      (SmPC).

    • Introduction

      17

      The PRAC and CHMP work plans for 2023 [1,2] list several activities intended to implement guidance

      18

      on ?Special populations and products?.

    • This includes further optimising close cooperation between

      19

      these two Committees for the revision of the ?CHMP Guideline on risk assessment of medicinal products

      20

      on human reproduction and lactation: from data to labelling (EMEA/CHMP/203927/2005)? [3].

    • Further, there is guidance on how to communicate the potential or identified risk through

      29

      the Summary of Product Characteristics (SmPC).

    • 46

      Most data regarding human pregnancy exposures are collected after marketing authorisation by

      47

      spontaneously reported post-authorisation data, in patient/pregnancy registries, and via

      48

      epidemiological studies undertaken in such data sources [7].

    • Such data sources are available in the

      49

      EU, as compiled by the European Network of Centres for Excellence in Pharmacovigilance and

      50
      51

      Pharmacoepidemiology (ENCePP) 1.

    • The development of
      1
      2

      http://www.encepp.eu/structure/documents/Data_sources_for_medicines_in_p...
      https://database.ich.org/sites/default/files/ICH_E21_Final_Concept_Paper...

      Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
      on Human Reproduction and Lactation: from Data to Labelling
      EMA/CHMP/170670/2024

      Page 2/6

      57

      physiologically based pharmacokinetic (PBPK)-modelling approaches may facilitate the prediction of

      58

      drug exposure in breast milk based on scarce data.

    • Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III ? Pregnancy

      70

      prevention programme and other pregnancy-specific risk minimisation measures

      71

      (EMA/608947/2021) 4,

      72

      3.

    • Recommendation

      137

      The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk

      138

      Assessment Committee (PRAC) recommends the revision of the current ?Guideline on risk assessment

      139

      of medicinal products on human reproduction and lactation: from data to labelling? considering the

      140

      issues identified above.

    • Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
      on Human Reproduction and Lactation: from Data to Labelling
      EMA/CHMP/170670/2024

      Page 5/6

      167

      [2] EMA/CHMP.

    • Guideline on risk assessment of medicinal products on human reproduction and

      171

      lactation: from data to labelling (EMEA/CHMP/203927/2005).

    • 188

      Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products
      on Human Reproduction and Lactation: from Data to Labelling
      EMA/CHMP/170670/2024

      Page 6/6

Wheaton Precious Metals Announces Election of Directors and Approval of Special Matters and Welcomes New Board Member

Retrieved on: 
fredag, maj 10, 2024
AngloGold Ashanti, Metal, International Council, Special, Mining, Vedanta Resources, Endeavour, Mine, BlackRock

Mr. Venkatakrishnan has a proven track record of leading multinational organizations - including major publicly listed companies - through periods of challenging and transformative change.

Key Points: 
  • Mr. Venkatakrishnan has a proven track record of leading multinational organizations - including major publicly listed companies - through periods of challenging and transformative change.
  • He is currently the Chair of Endeavour Mining plc.
  • He was also, until March 31, 2024, a Director of Weir Group Plc.
  • In his early career, he was a Director with Deloitte in London, leading corporate restructurings on behalf of both corporates and financiers.

Designing Patient-Centric Trials on a Budget: A Quantitative Framework, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
onsdag, maj 1, 2024
Digital, Clinical trial, Collection, International Council, ICH, Safety, Harmonization, Risk, Medical device

TORONTO, May 1, 2024 /PRNewswire-PRWeb/ -- Sponsors and study teams must navigate considerable uncertainty to ensure safety and efficacy endpoints meet the approval of health authorities, regulatory agencies and payers. They must achieve this while also ensuring studies are patient-centric and that key risks are mitigated while collecting complete data to support approval.

Key Points: 
  • In this free webinar, attendees will gain insights into strategies for optimizing the allocation of limited resources to maximize the impact of clinical trials.
  • The featured speakers will discuss a study design and authoring solution that can help in ensuring an effective and patient-centric trial design.
  • This webinar will provide a clear framework and methodology to optimize the design of clinical trials to achieve key outcomes in resource-constrained environments.
  • Register for this webinar today to gain insights into a study design and authoring solution that can help in ensuring an effective and patient-centric trial design.

ALABAMA POWER ANNOUNCES ADDITIONS TO BOARD OF DIRECTORS

Retrieved on: 
måndag, april 29, 2024
University, The Business Council, Huntingdon College, Committee of 100, Howell, International Council, Trustee, Country club, JWA, Shopping, Alabama Wildlife Federation, Commerce, Committee, Tuscaloosa Academy

BIRMINGHAM, Ala., April 29, 2024 /PRNewswire/ -- Lee Goodloe, Larry Howell and Will Wilson have been elected to the Alabama Power Board of Directors.

Key Points: 
  • BIRMINGHAM, Ala., April 29, 2024 /PRNewswire/ -- Lee Goodloe, Larry Howell and Will Wilson have been elected to the Alabama Power Board of Directors.
  • "We are pleased to welcome these accomplished leaders to our board of directors," said Alabama Power president and CEO Jeff Peoples.
  • Goodloe serves on the Southern Pine Inspection Bureau Board of Governors, the American Lumber Standards Committee, and the Business Council of Alabama Board of Directors.
  • Howell is a recognized leader in professional and civic organizations, serving on the boards of directors of the Business Council of Alabama, the Alabama Wildlife Federation, and the Pallet Foundation.

Al Shindagha Museum - A Modern Journey through Dubai's Rich Heritage and Cultural Tapestry

Retrieved on: 
måndag, april 29, 2024
Arts, Museums, Entertainment, Dubai Creek, Dubai Culture, International Council, MENASA, Conference, ICOM, House, General conference, International Council of Museums, Culture, Multimedia, Emirati, Tourism

Managed by the Dubai Culture & Arts Authority (Dubai Culture), the museum is a testament to the UAE’s rich heritage and cultural tapestry.

Key Points: 
  • Managed by the Dubai Culture & Arts Authority (Dubai Culture), the museum is a testament to the UAE’s rich heritage and cultural tapestry.
  • View the full release here: https://www.businesswire.com/news/home/20240423357515/en/
    Al Shindagha Museum, the UAE’s largest heritage museum on the banks of Dubai Creek (Photo: AETOSWire)
    Al Shindagha Museum, the UAE's largest heritage museum, is a prominent stop in the route to understanding Dubai.
  • Al Shindagha Museum pavilions strive to present a balance between passive and interactive interpretation models.
  • Al Shindagha Museum plays a critical role as a custodian of Dubai’s diverse cultural heritage.

Freeport-McMoRan Publishes 2023 Annual Report on Sustainability

Retrieved on: 
fredag, april 26, 2024
Mining, Minerals, Environment, Manufacturing, Sustainability, Natural Resources, Steel, Copper, International, Grasberg, Annual report, Molybdenum, International Council, Gold, Metal, Multimedia, FCX

Freeport-McMoRan Inc. (NYSE: FCX) today announced the publication of its 2023 Annual Report on Sustainability detailing its environmental, social and governance performance during the year.

Key Points: 
  • Freeport-McMoRan Inc. (NYSE: FCX) today announced the publication of its 2023 Annual Report on Sustainability detailing its environmental, social and governance performance during the year.
  • This report marks FCX’s 23rd year of reporting on its sustainability progress.
  • This year’s report details our progress in 2023 to further embed our sustainability strategy into the business: Accelerate the Future, Responsibly.”
    FCX’s 2023 Annual Report on Sustainability was prepared in alignment with the International Financial Reporting Standards Foundation's SASB Standards for the Metals & Mining industry (2023) as well as in reference to the GRI Sustainability Report Standards (2021) and the G4 Mining and Metals Sector Supplement (2013) and reflects FCX’s reporting obligations as a founding member of the International Council on Mining and Metals.
  • FCX’s 2023 Annual Report on Sustainability is available on the company website at fcx.com/sustainability .

International Symposium on the Concept of Intercultural Exchanges and Mutual Learning Successfully Convenes at UNESCO Headquarters

Retrieved on: 
torsdag, april 18, 2024
Professional Services, Events, Concerts, Arts, Museums, Thought Leadership, Entertainment, Climate change, UCA, Xinhua News Agency, Silk, Monument, Dialogue, Exhibition, UNESCO Courier, Communist party, International Council, UNESCO, Eiffel, Central committee, Silk Road, Speech, Future, International Association, Eiffel Tower, Concept, Multimedia, Fruit, Movement, Tourism

Inscribed with the word “world” in five languages, this artwork by international youth embodies hopes for a future enriched by intercultural dialogue.

Key Points: 
  • Inscribed with the word “world” in five languages, this artwork by international youth embodies hopes for a future enriched by intercultural dialogue.
  • It serves as an opener to an international symposium on the concept of intercultural exchanges and mutual learning among civilizations, a collaborative effort between China’s State Council Information Office, UNESCO, and the China’s National Commission for UNESCO, held on April 15 in Paris.
  • View the full release here: https://www.businesswire.com/news/home/20240418269051/en/
    International Symposium on the Concept of Intercultural Exchanges and Mutual Learning (Photo: Business Wire)
    The symposium unfolded both inside and outside the venue with vibrant displays and rigorous discussions.
  • Inside, experts and scholars discussed the theme of “Intercultural Dialogue and Mutual Learning: Shared Horizons”, and commended China’s significant contributions to these global exchanges.

Newmont Publishes 2023 Sustainability Report and 2023 Tax & Royalties Report

Retrieved on: 
torsdag, april 18, 2024
Environment, Human Resources, Environmental Health, Accounting, Professional Services, Sustainability, Mining, Minerals, DEI (Diversity, Equity and Inclusion), Environmental, Social and Governance (ESG), Natural Resources, NEM, ICMM, Report, UN, Parity, Cerro Negro, Corporation, Responsibility, Safety, Work, TSX, ASX, GRI, International Council, Dow Jones, Female, Friends, Gold, Tax, ESG, Sustainability accounting, Multimedia, NGT, COVID-19

Newmont Corporation (NYSE: NEM, TSX: NGT, ASX: NEM, PNGX: NEM) today published its 2023 Sustainability Report and its 2023 Taxes and Royalties Contributions Report .

Key Points: 
  • Newmont Corporation (NYSE: NEM, TSX: NGT, ASX: NEM, PNGX: NEM) today published its 2023 Sustainability Report and its 2023 Taxes and Royalties Contributions Report .
  • This year marks the 20th anniversary for Newmont’s Annual Sustainability Report, representing a milestone for the company as a longstanding industry leader in sustainability.
  • View the full release here: https://www.businesswire.com/news/home/20240417961090/en/
    Newmont's 2023 Sustainability Report (Graphic: Business Wire)
    "Our 2023 Sustainability Report demonstrates our unwavering commitment to responsible resource management and the integral role that Newmont plays in creating a more sustainable future," said Newmont Chief Safety and Sustainability Officer Suzy Retallack.
  • Highlights of Newmont’s 2023 Taxes and Royalties Contribution Report:
    Our strong sustainability focus also delivered significant economic benefits for our stakeholders, as detailed in our third annual Taxes and Royalties Contribution Report .

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Retrieved on: 
torsdag, april 18, 2024
Reproduction, Particle size, Q&A, Patient, Lung, Chronic obstructive pulmonary disease, DPI, Pharmacokinetics, Child, Isocyanate, International Council, Scope, Abbreviation, Asthma, OIP, European, COPD, APSD, Absorption, Rheumatology, Risk, Draft, EMA, Safety, TE, CHMP, MDI, Pharmacodynamics, IVIVC, Documentation, Taste, Comparison, Inhalation, Charcoal, Clinical Trials Directive, The central science, Drug development, Literature, ICH, Guideline, Gastrointestinal tract, GI, Marketing, Medication package insert, Excipient, Quality, QWP, Medical device

21

Key Points: 
    • 21

      Guideline on the requirements for demonstrating
      therapeutic equivalence between orally inhaled products
      (OIP) for asthma and chronic obstructive pulmonary
      disease (COPD)

      22

      Table of contents

      23

      Executive summary ..................................................................................... 4

      24

      1.

    • Primary PK parameters to be analysed and acceptance criteria .............................. 14

      43

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      51

      6.4.

    • Definitions ........................................................................................... 18

      56

      List of Abbreviations.................................................................................. 20

      57

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      58

      Executive summary

      59

      This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

      60

      for clinical documentation for orally inhaled products (OIP) including the requirements for

      61

      demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

      62

      asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

      63

      asthma in children and adolescents?.

    • It addresses the requirements for demonstration of therapeutic

      64

      equivalence (TE) between orally inhaled products containing the same active moiety(ies).

    • It is generally not recommended to aim at demonstrating TE using pharmacodynamic

      70

      or clinical endpoints as these are deemed insensitive.

    • This

      83

      guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

      84

      same active moiety(ies) and used in the management and treatment of patients with asthma and/or

      85

      COPD.

    • 86

      The guideline was first published as points to consider in 2004 and revised for the first time and

      87

      became guideline in 2009.

    • Since then, a number of Q&A documents have been published by Quality

      88

      Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).

    • Scope

      93

      This document provides guidance on the requirements for demonstrating TE between OIPs, including

      94

      both, single active substance products and combination products.

    • Also, in the case that there is a need

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      98

      to confirm similarity to a product for which literature data is available (e.g., well-established use

      99

      applications), the same principles apply.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      132

      4.

    • Products for nebulisation

      177

      This guideline applies also for products for nebulisation although it is acknowledged that the

      178

      performance of these is highly dependent on the nebuliser used.

    • In vitro criteria for demonstrating TE

      206

      The test and reference products should be compared in order to conclude on TE.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      211
      212

      2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      353

      6.2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      392

      6.3.

    • If the
      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      432

      different strengths of the test and the reference product are not shown to be proportional in vitro, in

      433

      vivo equivalence should be demonstrated with a bracketing approach.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      471

      6.4.

    • Griffin, 1964

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      553

      which both reference product-na?ve and experienced users should be included.

    • 568

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      569

      10.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      Product strength

      Product strength may be either the delivered
      dose or the metered dose.

    • 570

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      571

      List of Abbreviations
      APSD

      Aerodynamic Particle Size Distribution

      AUC

      Area Under the Curve

      CHMP

      Committee for Medicinal Products for Human
      Use

      CI

      Confidence Interval

      Cmax

      Peak concentration

      COPD

      Chronic Obstructive Pulmonary Disease

      DPI

      Dry Powder Inhaler

      FPD

      Fine Particle Dose

      GI

      Gastrointestinal

      ICH

      International Conference on Harmonisation

      IVIVC

      In vitro in vivo correlation

      MDI

      Metered Dose Inhaler

      OIP

      Orally Inhaled Product

      PD

      Pharmacodynamic

      PK

      Pharmacokinetic

      pMDI

      Pressurised Metered Dose Inhaler

      QWP

      Quality Working Party

      SmPC

      Summary of Product Characteristics

      TE

      Therapeutic equivalence

      tmax

      Time to peak concentration

      572

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024