ICSR | Jotup

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:

Dienstag, Januar 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:

Dienstag, Januar 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:

Dienstag, Januar 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:

Dienstag, Januar 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.

Expediting R&D Digitization for Life Sciences, ArisGlobal Introduces LifeSphere® NavaX™ - The Next-Generation Cognitive Computing Engine

Retrieved on:

Donnerstag, Dezember 14, 2023

Organization, Pressure, Gen, Natural language processing, Regulation, ICSR, NLP, CIO, Machine learning, Automation, R, PV, Gartner, Renewable energy, Fine chemical

BOSTON, Dec. 14, 2023 /PRNewswire/ -- ArisGlobal, a market leader in Life Sciences technology and the creator of LifeSphere®, has today launched LifeSphere NavaX, a cutting-edge cognitive computing engine to expedite R&D IT Digitization by leveraging advanced technologies including Large Language Models (LLM) and Generative AI (Gen AI).

Key Points:

Today, LifeSphere NavaX includes next-generation technologies that will bring comprehensive efficiency gains across the end-to-end PV and regulatory processes.
Aman Wasan, CEO of ArisGlobal, said: "Our vision is to transform the R&D IT ecosystem with advanced technology.
With more than 30 years of experience in the Life Sciences industry, ArisGlobal team will work closely with each customer to unlock exceptional benefits with NavaX."
LifeSphere NavaX builds on our proven platform, allowing the Life Sciences industry access to digital innovations that are driving the world forward."

Expediting R&D Digitization for Life Sciences, ArisGlobal Introduces LifeSphere® NavaX™ - The Next-Generation Cognitive Computing Engine

Retrieved on:

Donnerstag, Dezember 14, 2023

Organization, Pressure, Gen, Natural language processing, Regulation, ICSR, NLP, CIO, Machine learning, Automation, R, PV, Gartner, Renewable energy, Fine chemical

BOSTON, Dec. 14, 2023 /PRNewswire/ -- ArisGlobal, a market leader in Life Sciences technology and the creator of LifeSphere®, has today launched LifeSphere NavaX, a cutting-edge cognitive computing engine to expedite R&D IT Digitization by leveraging advanced technologies including Large Language Models (LLM) and Generative AI (Gen AI).

Key Points:

Today, LifeSphere NavaX includes next-generation technologies that will bring comprehensive efficiency gains across the end-to-end PV and regulatory processes.
Aman Wasan, CEO of ArisGlobal, said: "Our vision is to transform the R&D IT ecosystem with advanced technology.
With more than 30 years of experience in the Life Sciences industry, ArisGlobal team will work closely with each customer to unlock exceptional benefits with NavaX."
LifeSphere NavaX builds on our proven platform, allowing the Life Sciences industry access to digital innovations that are driving the world forward."

New Study Confirms Power of Real-World Data in Proactive Signal Detection, Improving Patient Safety

Retrieved on:

Mittwoch, November 8, 2023

Signal, DEC, US, Product management, Data, Disulfiram-like drug, ICSR, Comparison, EMR, Noise, AE, Patient safety, Therapeutic drug monitoring, Patient, Instrumentation, Pharmaceutical industry, Medical imaging, Safety, EU

BOSTON, Nov. 8, 2023 /PRNewswire/ -- ArisGlobal, creator of the LifeSphere® technology platform and a market leader in global patient treatment solutions, has announced striking new study results confirming the power of Proactive Safety Signal Detection in improving patient safety. Specifically, the findings support the technology's ability to distill precise, meaningful drug-event insights directly and efficiently from real-world data, boosting drug safety – while potentially also supporting new indications.

Key Points:

A foundational and comparative study of ArisGlobal's LifeSphere® Proactive Signal Detection technology, drew on 12 years of Individual Case Safety Reports (ICSRs) (over 6 million, from Vigibase) and EMR and claims records (18,000, c/o Patient Lives).
She commented: "Our innovative and proven Proactive Signal Detection technology will revolutionize Pharmacovigilance (PV) with a direct impact on patient safety, as well as a drug's addressable market.
"But now smart analytics, applied to robust real-world data, makes comprehensive, proactive signal detection a reliable reality.
ArisGlobal's CEO, Mike Gordon, commented, "Proactive signal detection that leverages real-world data will transform patient safety, while overcoming many of the frustrations experienced by drug companies, regulators and clinicians around post-market drug monitoring."

New Study Confirms Power of Real-World Data in Proactive Signal Detection, Improving Patient Safety

Retrieved on:

Mittwoch, November 8, 2023

BOSTON, Nov. 8, 2023 /PRNewswire/ -- ArisGlobal, creator of the LifeSphere® technology platform and a market leader in global patient treatment solutions, has announced striking new study results confirming the power of Proactive Safety Signal Detection in improving patient safety. Specifically, the findings support the technology's ability to distill precise, meaningful drug-event insights directly and efficiently from real-world data, boosting drug safety – while potentially also supporting new indications.

Key Points:

A foundational and comparative study of ArisGlobal's LifeSphere® Proactive Signal Detection technology, drew on 12 years of Individual Case Safety Reports (ICSRs) (over 6 million, from Vigibase) and EMR and claims records (18,000, c/o Patient Lives).
She commented: "Our innovative and proven Proactive Signal Detection technology will revolutionize Pharmacovigilance (PV) with a direct impact on patient safety, as well as a drug's addressable market.
"But now smart analytics, applied to robust real-world data, makes comprehensive, proactive signal detection a reliable reality.
ArisGlobal's CEO, Mike Gordon, commented, "Proactive signal detection that leverages real-world data will transform patient safety, while overcoming many of the frustrations experienced by drug companies, regulators and clinicians around post-market drug monitoring."

COSO Releases New "Achieving Effective Internal Control Over Sustainability Reporting" (ICSR) Supplemental Guidance

Retrieved on:

Donnerstag, März 30, 2023

MONTVALE, N.J., March 30, 2023 /PRNewswire/ -- The Committee of Sponsoring Organizations of the Treadway Commission (COSO) today released a groundbreaking study with supplemental guidance for organizations to achieve effective internal control over sustainability reporting (ICSR), using the globally recognized COSO Internal Control-Integrated Framework (ICIF). COSO believes its use will build trust and confidence in ESG/sustainability reporting, public disclosures, and enterprise decision-making.

Key Points:

MONTVALE, N.J., March 30, 2023 /PRNewswire/ -- The Committee of Sponsoring Organizations of the Treadway Commission (COSO) today released a groundbreaking study with supplemental guidance for organizations to achieve effective internal control over sustainability reporting (ICSR), using the globally recognized COSO Internal Control-Integrated Framework (ICIF).
Leveraging the significant knowledge gained in the application of ICIF to financial reporting over the past two decades, "Achieving Effective Internal Control over Sustainability Reporting (ICSR): Building Trust and Confidence through the COSO Internal Control―Integrated Framework" introduces "internal control over sustainability reporting" (ICSR) into the internal control lexicon.
"Effective internal control is good for business and applies well beyond external financial reporting as COSO's ICIF points out.
For more information and to download a free copy of Achieving Effective Internal Control over Sustainability Reporting (ICSR): Building Trust and Confidence through the COSO Internal Control―Integrated Framework, please visit www.coso.org .

Reshaping Global ICSR Reporting to Deliver Real-Time Visibility and Oversight, Upcoming Webinar Hosted by Xtalks

Retrieved on:

Dienstag, Oktober 11, 2022

Food, Pharmacovigilance, Hotel manager, Compliance, Veeva Systems, Industry, ICSR, Collection, Safety, Technology, Data management, Medical device

TORONTO, Oct. 11, 2022 /PRNewswire-PRWeb/ -- Directly supporting multilingual case processing and regional regulatory requirements in a global pharmacovigilance solution, eliminates multiple reporting systems and provides a single trusted source of safety information. With real-time and unified data foundation, it is easier to track compliance and enable more timely reporting, submissions and distribution. In this webinar, the featured speaker will focus on managing ICSR reporting with improved pharmacovigilance solutions.

Key Points:

In this free webinar, learn about the challenges and approaches to safety data management and ICSR reporting.
In this webinar, the featured speaker will focus on managing ICSR reporting with improved pharmacovigilance solutions.
Register to learn about reshaping global ICSR reporting to deliver real-time visibility and oversight.
For more information, or to register for this event, visit Reshaping Global ICSR Reporting to Deliver Real-Time Visibility and Oversight .