Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
List view / Grid view
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
Rama Rao, CEO of Bloqcube, discusses the benefits of blockchain-based systems for clinical trials and how their implementation could revolutionise drug development.
The Pistoia Alliance's Data Governance Community of Interest will develop best practices and advance digital transformation in the pharma/life sciences industry.
The big debate. Beyond the data and document distinction: how to transform life sciences experiences via improved information flow
The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis…
The pressures of the pandemic have brought into sharp focus the need for greater innovation and modernisation across the pharmaceutical industry. This is especially the case when it comes to traditional clinical trials, which have often been marred by costly, inefficient and logistically demanding processes. But things are changing and…
Moving towards the digitalisation of your lab, with the 8th edition of the Paperless Lab Academy® – this year, online
Master your eData Life Cycle is the theme of the 8th edition of the Paperless Lab Academy®, running online this year due to the pandemic.
In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response…
A new report suggests artificial intelligence (AI) will be the most disruptive technology in the pharmaceutical industry this year and beyond.
In this article, Alison Bourke, Scientific Director of the Center for Advanced Evidence Generation at IQVIA Health, explores how digitally-connected active and passive data sources are shaping the development of patient-centric treatments and care.
13 January 2021 | By Altasciences
Watch this webinar on-demand which presents an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorisation (CTA) processes to that of the FDA IND submission.
4 August 2020 | By Thermo Fisher Scientific
Find out more about industry issues, solutions, trends and how LIMS can enable laboratories to accelerate science and drive productivity, while ensuring regulatory compliance in our on-demand webinar.
The genomic research platform will initially be used to help fast-track COVID-19 drug research and development, before being leveraged against other diseases, such as cancer.