INFOGRAPHIC: “The Future of Regulatory Information Management”
Learn how leading pharmaceutical, biotech, contract research organizations and health authorities are transforming Regulatory Affairs
Advertorial: The Role of Artificial Intelligence within Pharmacovigilance and Medical Information
There are a myriad potential uses of AI for Medical Information and pharmcovigilance, and if you don’t have an AI strategy you will be left behind. AI will allow us to automate.....
Chinese Pharmacovigilance Landscape – A Shift from Manual to Electronic Systems
Major regulatory reforms for drugs and medical devices are being initiated in China to ensure safe, innovative, effective and high-quality medicinal products are available to its population. As part of this initiative
Automated Segregation of Relevant ICSRs from EudraVigilance
One of the key requirements of the new pharmacovigilance legislation (Regulation 726/2004) in the EU is simplified reporting of individual case safety reports (ICSRs) by a Marketing Authorization Holder (MAH) to the new EudraVigilance (EV) system
Practical Implementation of GDPR within Medical Information: A Post-Webcast Perspective
This blog recaps ArisGlobal’s recent webcast on the GDPR implementation within medical information systems and examines audience polling results related to readiness, compliance, and more
Practical Implementation of GDPR with Medical Information
On May 25, 2018 the long awaited Global Data Privacy Regulation (GDPR) was implemented. For breaking the law, companies will pay up to 4% of their global revenues or €20 million, whichever is greater. But GDPR within medical information is a grey area.
From Push and Pull with EMA: A Modern Take on Triaging Adverse Events
In October 2017, the European Medicines Agency (EMA) changed the way in which they deliver safety information to Marketing Authorisation Holders. In the past, they would push the information via a gateway-to-gateway connection in an R2 format.....
Pharmacovigilance in China – Current Updates, Challenges and Solutions for the Industry
The Chinese Federal Drug Authority (CFDA) regulations are changing and ...
LifeSphere MultiVigilance (formerly ARISg/ARISc) – A Pharmacovigilance Database for Chinese Regulatory Compliance
China is aligning its regulatory environment with that of global standards with an aim to promote innovation, simplify drug development processes and to enhance the efficacy, quality and safety of the drugs approved. Read this whitepaper to learn how LifeSphere Safety MultiVigilance (ARISc), the drug safety software
