OIE

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

NASDAQ-listed Agape ATP Unveils Expansion Plans and Green Initiatives at Opening Bell Ringing Ceremony

Retrieved on: 
Wednesday, January 24, 2024

KUALA LUMPUR, Jan 24, 2024 - (ACN Newswire) - Homegrown Nasdaq listed Agape ATP Corporation ("ATPC" or the "Company"; NASDAQ: ATPC) announces the Company's move to push forward its Sustainability Green Energy Initiative at the NASDAQ Opening Bell Ringing Ceremony hosted by ATPC at the Kuala Lumpur Convention Centre recently.

Key Points: 
  • KUALA LUMPUR, Jan 24, 2024 - (ACN Newswire) - Homegrown Nasdaq listed Agape ATP Corporation ("ATPC" or the "Company"; NASDAQ: ATPC) announces the Company's move to push forward its Sustainability Green Energy Initiative at the NASDAQ Opening Bell Ringing Ceremony hosted by ATPC at the Kuala Lumpur Convention Centre recently.
  • These efforts, enhanced by our partnerships, are a testament to how environmental sustainability and corporate growth can successfully coexist.
  • We stand here today, poised for a future where green energy is not just an option, but a driving force for innovation and prosperity."
  • Further contributing to this wave of sustainable initiatives, VOLT has independently signed a Memorandum of Understanding (MOU) with KAB Smart Solar Energy Sdn.

Innosphere Ventures Receives $2 Million U.S. EDA Grant to Power Innovation and Boost Life Sciences Ecosystem Building in the Heart of America

Retrieved on: 
Thursday, November 9, 2023

The U.S. EDA award signifies a critical investment in the future of life sciences innovation.

Key Points: 
  • The U.S. EDA award signifies a critical investment in the future of life sciences innovation.
  • This grant enables us to drive innovation, strengthen the life sciences ecosystem, and create lasting economic impact not just locally but for the entire United States."
  • "We extend a warm invitation to entrepreneurs, university faculty, investors, foundations, and all stakeholders who share our vision of advancing the life sciences ecosystem.
  • This grant represents a pivotal moment for Innosphere Ventures and the broader innovation community in the central United States.

Nasdaq-Listed AGAPE Forges Ahead with Sustainable Energy Business

Retrieved on: 
Wednesday, November 8, 2023

("Volt Industries") in Pahang as part of the Company's strategy to develop and offer sustainable energy solutions.

Key Points: 
  • ("Volt Industries") in Pahang as part of the Company's strategy to develop and offer sustainable energy solutions.
  • ATPC, which was recently listed on Nasdaq, specializes in sustainable global 'wellness' ecosystem and the development and production of advanced technology solutions for the energy sector.
  • Dato' Sri Dr. How Kok Choong, the founder of AGAPE ATP, said: "Our recent IPO on Nasdaq was just the beginning.
  • This MoA signifies ATPC's expansion into the sustainable energy space, reflecting our ambitions on both the local and global stages.

Yubico Delivers Secure, Seamless Passwordless Onboarding and Account Recovery with FIDO Pre-reg

Retrieved on: 
Wednesday, October 4, 2023

Yubico ( NASDAQ: YUBICO ), the leading provider of hardware authentication security keys, announced the initial availability of FIDO Pre-reg , an industry-first capability that delivers secure and seamless passwordless onboarding and account recovery/reset from day one at scale for enterprises.

Key Points: 
  • Yubico ( NASDAQ: YUBICO ), the leading provider of hardware authentication security keys, announced the initial availability of FIDO Pre-reg , an industry-first capability that delivers secure and seamless passwordless onboarding and account recovery/reset from day one at scale for enterprises.
  • Available exclusively as part of YubiEnterprise Subscription , FIDO Pre-reg simplifies the way organizations can adopt modern, phishing-resistant MFA with a frictionless and easy user experience.
  • “Organizations have historically been challenged to accelerate user adoption of phishing-resistant MFA and FIDO passkey solutions like YubiKeys at speed and scale,” said Jeff Wallace, senior vice president, product at Yubico.
  • If you’re an identity provider and are interested in learning more about FIDO Pre-Reg, contact us .

BeyondID Launches Initiative to Accelerate Zero Trust with Okta Identity Engine

Retrieved on: 
Tuesday, June 6, 2023

SAN FRANCISCO, June 6, 2023 /PRNewswire/ -- BeyondID, a leading managed identity services provider of cybersecurity and cloud services, today announced it is helping organizations deliver on their zero trust strategy by expediting their upgrades to the Okta Identity Engine (OIE). BeyondID's services offer customers a clear upgrade roadmap, including implementing comprehensive security features such as passwordless protection and Okta FastPass.

Key Points: 
  • Okta's updated OIE platform delivers a secure passwordless experience with phishing resistant authenticators in a flexible and scalable identity platform as the foundation of zero trust architecture.
  • BeyondID facilitates a seamless upgrade from Okta Classic Engine to OIE and integrates apps and tools to ensure a higher adoption of new OIE features.
  • Our partnership with BeyondID empowers customers to accelerate their OIE deployments and maximize their Okta investment."
  • To learn more about how BeyondID can accelerate your organization's zero trust strategy and deploy the Okta Identity Engine, visit: https://beyondid.com/services/oie-upgrade/ .

ASEAN Rabies Veterinary Vaccines Market Size, Share & Trends Analysis Report, 2022-2023 & 2030

Retrieved on: 
Tuesday, February 14, 2023

DUBLIN, Feb. 14, 2023 /PRNewswire/ -- The "ASEAN Rabies Veterinary Vaccines Market Size, Share & Trends Analysis Report By Application (Companion Animals, Livestock Animals), By Country, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 14, 2023 /PRNewswire/ -- The "ASEAN Rabies Veterinary Vaccines Market Size, Share & Trends Analysis Report By Application (Companion Animals, Livestock Animals), By Country, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The market is primarily driven by growing rabies vaccination coverage among dogs in ASEAN countries, rising awareness regarding zoonotic diseases, and increasing government initiatives to eradicate animal and human rabies by the end of 2030.
  • Appropriate management of the disease in domestic dog populations is essential for the prevention of rabies in humans.
  • The majority of documented rabies cases in both animals and humans of ASEAN countries are caused by dogs.

Animal health giant introduces vaccine in Middle East and North Africa to control foot-and-mouth disease and improve livestock productivity

Retrieved on: 
Thursday, May 19, 2022

The seminar "Foot and Mouth Disease status in the Middle East" was attended by authorities who are responsible of protecting the health status of a region which has an estimated 1 billion heads of livestock, between sheep, goats, cattle and camelids.

Key Points: 
  • The seminar "Foot and Mouth Disease status in the Middle East" was attended by authorities who are responsible of protecting the health status of a region which has an estimated 1 billion heads of livestock, between sheep, goats, cattle and camelids.
  • "Biognesis Bags vaccine will be key to protecting the region's animal health status and productivity.
  • Dr. Esteban Turic, CEO at Biogenesis Bag, also emphasized about the region's main animal health issues and the company's approach towards working together for its control.
  • Biognesis Bag is an international biotechnology company with more than 80 years of experience, specialized in the development, production, and commercialization of products for animal health and productivity.

Global Pet Insurance Market is Expected to Grow at a CAGR of over 16.7% During 2022-2030 - ResearchAndMarkets.com

Retrieved on: 
Monday, March 14, 2022

The global pet insurance market size is anticipated to reach USD 32.7 billion by 2030.

Key Points: 
  • The global pet insurance market size is anticipated to reach USD 32.7 billion by 2030.
  • Similarly, pet insurance in Europe is growing rapidly due to strict pet insurance regulations in countries such as Sweden.
  • For instance, in April 2020, Zoetis entered the pet insurance space by launching Pumpkin Insurance Services Inc.- a pet insurance agency across the U.S.
  • Chapter 5 Pet Insurance Market: Segment Analysis, By Coverage Type, 2017-2030 (USD Million)
    5.1 Coverage Type Market Share Analysis, 2021 & 2030

Zoetis Named One of Most Innovative Companies in 2022 by Fast Company

Retrieved on: 
Wednesday, March 9, 2022

Zoetis has been named to Fast Companys list of Most Innovative Companies for 2022 , ranking eighth in the corporate social responsibility category.

Key Points: 
  • Zoetis has been named to Fast Companys list of Most Innovative Companies for 2022 , ranking eighth in the corporate social responsibility category.
  • In addition to the World's 50 Most Innovative Companies, 528 organizations are recognized across 52 categories.
  • In other recognitions of its progress on sustainability, Zoetis was named one of Newsweeks Most Responsible Companies for 2022 and was included in Investors Business Dailys 100 Best ESG Companies .
  • All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted.