article
Six major risks facing pharmaceutical manufacturers in 2021
In this article, Shannon Flynn outlines six of the key risks threatening pharmaceutical manufacturers’ recovery from COVID-19 in 2021.
List view / Grid view
Data integrity
news
ICMRA and WHO state clinical trial reports should be published without redaction
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
article
Bringing clinical trials into the new age with blockchain
Rama Rao, CEO of Bloqcube, discusses the benefits of blockchain-based systems for clinical trials and how their implementation could revolutionise drug development.
video
On-demand webinar: Optimising MALDI-TOF for filamentous fungi ID
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
webinar
Quality Risk Management tools to improve data integrity in micro QC
12 April 2021 | By Charles River Laboratories
Watch this on-demand webinar with Jordi Iglesias to learn how you can improve the data integrity of your microbiological QC assays.
news
New group to tackle data governance and guide digital transformation in pharma
The Pistoia Alliance's Data Governance Community of Interest will develop best practices and advance digital transformation in the pharma/life sciences industry.
article
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…
article
Decentralised clinical trials: paving the way for modernisation
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…
news
AstraZeneca confirms COVID-19 vaccine efficacy with primary analysis
Following DSMB concerns about the data released regarding the Phase III US trial, AstraZeneca has now confirmed that its vaccine is 76 percent effective against symptomatic COVID-19.
webinar
How data integrity is your first step toward a Pharma 4.0 strategy
25 March 2021 | By Thermo Fisher Scientific
Watch this webinar on demand to learn how a complete, integrated laboratory software system provides streamlined processes and drives data integrity, advancing organisations toward a Pharma 4.0 strategy.
news
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.
video
On-demand webinar: Testing disinfectant agents for antimicrobial action on hard surfaces
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
article
EMA’s new guide to implementing IDMP data standards triggers the countdown to change
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…
whitepaper
Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
![US Department of Justice logo on top of an American Flag [Credit: US-Department-of-Justice].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/US-Department-of-Justice-300x278.jpg)
![US Department of Justice logo on top of an American Flag [Credit: US-Department-of-Justice].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/US-Department-of-Justice-e1613474706496.jpg)
news
Fresenius Kabi Oncology Ltd to pay $50mn for destroying records ahead of an FDA Inspection
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
