European Economic Area

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 4 March 2024 to 8 March 2024

Retrieved on: 
Tuesday, January 2, 2024
Online, ICSR, European Economic Area, EMA, EudraVigilance, Terminology, EV, Announcement, ISO, Location, Environment

Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became

Key Points: 
  • Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became
    mandatory on 30 June 2022 for all reporting to EudraVigilance.
  • Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
  • Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.
  • Organisations which aim to register first user QPPV/RP or to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to the EMA to be able to successfully register with the EV production environment.

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 15 April 2024 to 19 April 2024

Retrieved on: 
Tuesday, January 2, 2024
Online, ICSR, European Economic Area, EMA, EudraVigilance, Terminology, EV, Announcement, ISO, Location, Environment

Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became

Key Points: 
  • Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became
    mandatory on 30 June 2022 for all reporting to EudraVigilance.
  • Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
  • Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.
  • Organisations which aim to register first user QPPV/RP or to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to the EMA to be able to successfully register with the EV production environment.

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 13 May 2024 to 17 May 2024

Retrieved on: 
Tuesday, January 2, 2024
Online, ICSR, European Economic Area, EMA, EudraVigilance, Terminology, EV, Announcement, ISO, Location, Environment

Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became

Key Points: 
  • Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became
    mandatory on 30 June 2022 for all reporting to EudraVigilance.
  • Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
  • Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.
  • Organisations which aim to register first user QPPV/RP or to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to the EMA to be able to successfully register with the EV production environment.

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 3 June 2024 to 7 June 2024

Retrieved on: 
Tuesday, January 2, 2024
Online, ICSR, European Economic Area, EMA, EudraVigilance, Terminology, EV, Announcement, ISO, Location, Environment

Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became

Key Points: 
  • Following the Announcement of the EMA Management Board1, the use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities became
    mandatory on 30 June 2022 for all reporting to EudraVigilance.
  • Furthermore, the use of ISO standard terminology for pharmaceutical dose forms and route of administration also became mandatory at the same time.
  • Following the completion of this course, participants who pass the knowledge evaluation will receive a notification from the EMA.
  • Organisations which aim to register first user QPPV/RP or to use EudraVigilance web application (EVWEB) to start the electronic reporting of ICSRs to EudraVigilance for the first time, need to provide such notification for at least one user to the EMA to be able to successfully register with the EV production environment.

RevoluPAY introduces Visa Direct to enable instant P2P payments through RevoluSEND

Retrieved on: 
Tuesday, December 12, 2023
European Economic Area, Partnership, Small business, Movement, TSX, Financial services

This innovative solution arrives amidst a growing trend among consumers favoring digital payments and demanding new methods for seamless money transfers.

Key Points: 
  • This innovative solution arrives amidst a growing trend among consumers favoring digital payments and demanding new methods for seamless money transfers.
  • Notably, 42% of Spaniards have embraced mobile payments at least once, according to Visa's data ( Visa and Pecunpay Mobile Payments Study, 2023 ).
  • To leverage Visa Direct, RevoluPAY clients using the RevoluSEND, can seamlessly access the new functionality for transferring funds to a card or account directly within the application.
  • Therefore, we are very proud to continue expanding this solution in Spain hand in hand with a disruptive partner like RevoluPAY," stated Eduardo Prieto, General Manager of Visa in Spain.

RevoluPAY introduces Visa Direct to enable instant P2P payments through RevoluSEND

Retrieved on: 
Tuesday, December 12, 2023
European Economic Area, Partnership, Small business, Movement, TSX, Financial services

This innovative solution arrives amidst a growing trend among consumers favoring digital payments and demanding new methods for seamless money transfers.

Key Points: 
  • This innovative solution arrives amidst a growing trend among consumers favoring digital payments and demanding new methods for seamless money transfers.
  • Notably, 42% of Spaniards have embraced mobile payments at least once, according to Visa's data ( Visa and Pecunpay Mobile Payments Study, 2023 ).
  • To leverage Visa Direct, RevoluPAY clients using the RevoluSEND, can seamlessly access the new functionality for transferring funds to a card or account directly within the application.
  • Therefore, we are very proud to continue expanding this solution in Spain hand in hand with a disruptive partner like RevoluPAY," stated Eduardo Prieto, General Manager of Visa in Spain.

Alvotech Reports Financial Results for First Nine Months of 2023 and Provides a Business Update

Retrieved on: 
Tuesday, November 28, 2023
Omalizumab, European Economic Area, European Commission, Partnership, Food, Johnson & Johnson, Food and Drug Administration, BLA, Business analyst, FDA, EMA, Marketing, Absorption, Research, Civil service commission, European Medicines Agency, Gross metropolitan product, Committee, Patient, Safety, Stada Arzneimittel, Webcast, G&A, Biosimilar, CHMP, Pharmaceutical industry

Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.

Key Points: 
  • Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.
  • Product Revenue: Product revenue was $29.8 million for the nine months ended September 30, 2023, compared to $11.1 million for the same nine months of 2022.
  • Income tax benefit: Income tax benefit was $67.1 million for the nine months ended September 30, 2023, compared to $14.8 million for the same nine months of 2022.
  • Alvotech will conduct a business update conference call and live webcast on Wednesday, November 29 at 8:00 am ET (13:00 GMT).

Mintegral Announces Registration to IAB's Europe's Transparency and Consent Framework, Updates SDK

Retrieved on: 
Wednesday, December 20, 2023
Apps, Applications, Mobile, Wireless, Technology, Other Communications, Advertising, Other Technology, Communications, Software, Internet, Data Management, ISO/IEC, European Economic Area, CMP, GDPR, CCPA, UMP, TCF, IAB, EEA, Privacy, COPPA, Interactive Advertising Bureau, Organization, SOC, Online shopping

Mintegral, Mobvista's programmatic advertising subsidiary, announced today that it has been approved as the latest vendor to join IAB Europe's Transparency and Consent Framework (V2.2 TCF).

Key Points: 
  • Mintegral, Mobvista's programmatic advertising subsidiary, announced today that it has been approved as the latest vendor to join IAB Europe's Transparency and Consent Framework (V2.2 TCF).
  • Mintegral has also launched updated SDKs to support the Google User Messaging Platform (UMP) and ensure compliance with the additional data protection regulations.
  • In addition to integrating with the IAB Transparency and Consent Framework, Mintegral has been issued SOC2 Type 2 and SOC 3 reports.
  • Mintegral has also successfully remained compliant with IAB OM SDK, GDPR, CCPA, and COPPA while receiving ISO/IEC 27001 and ePrivacyseal endorsements.

STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara

Retrieved on: 
Friday, November 10, 2023
Cytokine, European Economic Area, Safety, Dermatology, Perfusion, Psoriasis, EMA, Patient, Biosimilar, CHMP, Rheumatology, Psoriatic arthritis, Gastroenterology, Partnership, Adalimumab, Generic drug, Pharmaceutical industry, Vaccine, Ustekinumab

Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.

Key Points: 
  • Under a strategic partnership begun in 2019, Alvotech is primarily responsible for developing and manufacturing the AVT04 ustekinumab biosimilar.
  • STADA holds commercial rights within Europe, where the company already markets six approved biosimilars, including in gastrointestinal, dermatology and rheumatology indications.
  • STADA’s Global Specialty Head, Bryan Kim, commented: “This positive CHMP opinion puts STADA and Alvotech in prime position to improve patient access in the ustekinumab and interleukin inhibitor markets.
  • AVT04 was designed using the Sp2/0 host cell line and is manufactured using a perfusion process, like the reference product Stelara.

BetterUp Achieves Data Privacy Framework Certification

Retrieved on: 
Wednesday, December 13, 2023
Professional Services, Online Privacy, Business, Thought Leadership, Technology, Human Resources, Consulting, Gross metropolitan product, European Economic Area, Organization, California Consumer Privacy Act, European Commission, Salesforce, ISO 27001, Trans-Atlantic Data Privacy Framework, GDPR, Collection, Privacy, Commerce, Civil service commission, Government, ISO, European, General Data Protection Regulation, Trust, DPF, FedRAMP, Privacy policy, SOC, Type 2, Certification, CCPA, Policy, Medical device, Smallpdf.com, Travelodge, EEA

BetterUp®, the inventor of virtual professional coaching and global leader in peak performance for enterprises, is now a certified organization under the Data Privacy Framework (DPF) – which includes the EU-U.S. Data Privacy Framework, UK Extension to the EU-US Data Privacy Framework, and the Swiss-U.S. Data Privacy Framework – as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal data transferred from the European Economic Area (EEA), United Kingdom and Switzerland, to the United States.

Key Points: 
  • BetterUp®, the inventor of virtual professional coaching and global leader in peak performance for enterprises, is now a certified organization under the Data Privacy Framework (DPF) – which includes the EU-U.S. Data Privacy Framework, UK Extension to the EU-US Data Privacy Framework, and the Swiss-U.S. Data Privacy Framework – as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal data transferred from the European Economic Area (EEA), United Kingdom and Switzerland, to the United States.
  • As part of the certification process, BetterUp demonstrated its commitment to uphold DPF principles regarding all personal data received from the aforementioned regions and countries.
  • This certification builds on the company’s existing security program and Privacy Policy , which is in compliance with ISO 27001, General Data Protection Regulation (GDPR), California Consumer Privacy Act (CCPA), and AICPA’s Service Organization Control 2 (SOC 2) Type II reporting requirements.
  • Visit the Data Privacy Framework website to learn more about the program, and view BetterUp’s page on the Data Privacy Framework List to see the scope of BetterUp’s active certification.