European Economic Area

VASS wins a contract to run the European Employment Services (EURES) Helpdesk

Retrieved on: 
Monday, January 15, 2024

MADRID, Jan. 15, 2024 /PRNewswire/ -- VASS , a leading digital solutions company, announces has been awarded the contract for running the European Employment Services (EURES) Helpdesk for the fourth time in a row.

Key Points: 
  • MADRID, Jan. 15, 2024 /PRNewswire/ -- VASS , a leading digital solutions company, announces has been awarded the contract for running the European Employment Services (EURES) Helpdesk for the fourth time in a row.
  • EURES is a cooperation network formed by public employment services, partnering with national Trade Unions and employers' organizations.
  • It is also supported by the European Commission and the European Labour Authority (ELA).
  • Over the next four years, VASS will run the EURES Helpdesk, expecting contact with over 60,000 people – the number of users during the last contract.

Clinical Trials Information System (CTIS) bitesize talk: Training materials, CTIS pre-requisites, and updates on transparency rules, Online, European Medicines Agency, Amsterdam, the Netherlands, 29 November 2023

Retrieved on: 
Saturday, January 13, 2024

This bitesize talk on CTIS aims to provide sponsors with a reminder on the CTIS training materials, the prerequisites for sponsors before using CTIS, and the updates on the transparency rules.

Key Points: 
  • This bitesize talk on CTIS aims to provide sponsors with a reminder on the CTIS training materials, the prerequisites for sponsors before using CTIS, and the updates on the transparency rules.
  • Sponsors will also have the opportunity to ask questions on this CTIS topic before the event.
  • The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations.
  • To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials:

EDPB Urgent Binding Decision on processing of personal data for behavioural advertising by Meta

Retrieved on: 
Tuesday, January 2, 2024

The urgent binding decision followed a request from the Norwegian Data Protection Authority (NO DPA) to take final measures in this matter that would have effect in the entire European Economic Area (EEA).

Key Points: 
  • The urgent binding decision followed a request from the Norwegian Data Protection Authority (NO DPA) to take final measures in this matter that would have effect in the entire European Economic Area (EEA).
  • The Irish DPC has notified Meta on 31/10 about the EDPB Urgent Binding Decision.
  • Already in December 2022, the EDPB Binding Decisions clarified that contract is not a suitable legal basis for the processing of personal data carried out by Meta for behavioural advertising.
  • It is high time for Meta to bring its processing into compliance and to stop unlawful processing.”

EDPB publishes urgent binding decision regarding Meta

Retrieved on: 
Tuesday, January 2, 2024

The EDPB urgent binding decision followed a request from the Norwegian Data Protection Authority (NO DPA) to order final measures in this matter which would have effect in the entire European Economic Area (EEA).

Key Points: 
  • The EDPB urgent binding decision followed a request from the Norwegian Data Protection Authority (NO DPA) to order final measures in this matter which would have effect in the entire European Economic Area (EEA).
  • Already in December 2022, the EDPB Binding Decisions clarified that contract is not a suitable legal basis for the processing of personal data carried out by Meta for behavioural advertising.
  • In addition, Meta has been found by the IE DPA to not have demonstrated compliance with the orders imposed at the end of last year.
  • Already in December 2022, the EDPB Binding Decisions clarified that contract is not a suitable legal basis for the processing of personal data carried out by Meta for behavioural advertising.
  • This ban was limited in time and geographic scope: it was valid for three months and only applicable in Norway.

Background


Timeline

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system, Online, from 26 February 2024 to 28 February 2024

Retrieved on: 
Tuesday, January 2, 2024

Date

Key Points: 
  • Date
    - Monday, 26 February 2024 - Wednesday, 28 February 2024
    Location
    - Online
    Event summary
    EudraVigilance is the EU’s system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products.
  • Following the Announcement of the EMA Management Board, 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.

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system, Online, from 27 May 2024 to 29 May 2024

Retrieved on: 
Tuesday, January 2, 2024

Date

Key Points: 
  • Date
    - Monday, 27 May 2024 - Wednesday, 29 May 2024
    Location
    - Online
    Event summary
    EudraVigilance is the EU’s system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products.
  • Following the Announcement of the EMA Management Board, 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.

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 29 January 2024 to 2 February 2024

Retrieved on: 
Tuesday, January 2, 2024

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 4 March 2024 to 8 March 2024

Retrieved on: 
Tuesday, January 2, 2024

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

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

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.