EMA: Data quality framework for medicines regulation workshop

Datum: 7 April 2022
Tijd: 00:00 - 00:00
Locatie: Online

One of the Priority Recommendations of the HMA-EMA joint Big Data Task Force is to establish an EU framework for data quality that will support the trust of patients and healthcare professionals in the decisions reached by regulators, when various types of data underpin those decisions.
This workshop seeks to engage stakeholders early in the drafting process of an EU Network data quality framework, to ensure a robust starting point, in line with their expectations and needs.

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EMA: Clinical Trials Information System (CTIS): Walk-in clinic

Datum: 28 March 2022
Tijd: 16:00 - 17:00
Locatie: Online

This walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical about the Clinical Trials Information System by asking questions to CTIS experts in real-time.
The CTIS experts will address all the questions related to system functionalities. Questions about the interpretation of the Clinical Trial Regulation and /or national processes are out of the scope of this event.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. It will be live broadcast and no registration is required for those wishing to follow the live broadcast on EMA’s website.

In order to make the best out of this session, attendees are highly recommended to first consult the available online training and support materials:

CTIS online modular training programme, including frequently asked questions (FAQs) per module
CTIS Sponsor handbook
CTIS Reference materials for clinical trial sponsors

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EMA: Clinical Trials Information System (CTIS): Walk-in clinic

Datum: 22 April 2022
Tijd: 15:00 - 16:00
Locatie: Online

This walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical about the Clinical Trials Information System by asking questions to CTIS experts in real-time.
The CTIS experts will address all the questions related to system functionalities. Questions about the interpretation of the Clinical Trial Regulation and /or national processes are out of the scope of this event.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. It will be live broadcast and no registration is required for those wishing to follow the live broadcast on EMA’s website.

In order to make the best out of this session, attendees are highly recommended to first consult the available online training and support materials:

CTIS online modular training programme, including frequently asked questions (FAQs) per module
CTIS Sponsor handbook
CTIS Reference materials for clinical trial sponsors

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EMA: Clinical Trials Information System (CTIS): Walk-in clinic

Datum: 4 April 2022
Tijd: 16:00 - 17:00
Locatie: Online

This walk-in clinic on CTIS functionalities provides an opportunity for sponsors to receive practical about the Clinical Trials Information System by asking questions to CTIS experts in real-time.

The CTIS experts will address all the questions related to system functionalities. Questions about the interpretation of the Clinical Trial Regulation and /or national processes are out of the scope of this event.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. It will be live broadcast and no registration is required for those wishing to follow the live broadcast on EMA’s website.

In order to make the best out of this session, attendees are highly recommended to first consult the available online training and support materials:

CTIS online modular training programme, including frequently asked questions (FAQs) per module
CTIS Sponsor handbook
CTIS Reference materials for clinical trial sponsors

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EMA: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Startdatum: 4 July 2022
Einddatum: 8 July 2022
Tijd: 00:00 - 00:00
Locatie: Online

The European Medicines Agency (EMA) launched the enhanced EudraVigilance system in November 2017, which supports reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products. Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO standard terminology for pharmaceutical forms and route of administration will also become mandatory at the same time. The use of the ICH E2B (R2) format will therefore be phased out. The training course includes a knowledge evaluation for which participants, who pass the evaluation, will receive a notification from the EMA. Organisations, which aim 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 be able to successfully register with the EudraVigilance production environment.

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EMA: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Startdatum: 14 March 2022
Einddatum: 18 March 2022
Tijd: 00:00 - 00:00
Locatie: Online

The European Medicines Agency (EMA) launched the enhanced EudraVigilance system in November 2017, which supports reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products. Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO standard terminology for pharmaceutical forms and route of administration will also become mandatory at the same time. The use of the ICH E2B (R2) format will therefore be phased out. The training course includes a knowledge evaluation for which participants, who pass the evaluation, will receive a notification from the EMA. Organisations, which aim 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 be able to successfully register with the EudraVigilance production environment.

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EMA: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Startdatum: 18 May 2022
Einddatum: 20 May 2022
Tijd: 00:00 - 00:00
Locatie: Amsterdam

The European Medicines Agency (EMA) launched the enhanced EudraVigilance system in November 2017, which supports reporting and analysis of suspected adverse reactions originating from clinical trials and the post-authorisation phase of medicinal products. Based on a Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, the EMA Management Board confirmed and announced the mandatory use of the ISO Individual Case Safety Report (ICSR) standard based on the ICH E2B(R3) modalities as of 30 June 2022 for all reporting to EudraVigilance. Furthermore, the ISO standard terminology for pharmaceutical forms and route of administration will also become mandatory at the same time. The use of the ICH E2B (R2) format will therefore be phased out. The training course includes a knowledge evaluation for which participants, who pass the evaluation, will receive a notification from the EMA. Organisations, which aim 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 be able to successfully register with the EudraVigilance production environment.

Continue Reading