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Regulatory Resources
19 results
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Contributor: Pharma IQ News
Posted: 06/09/2017
Pharma IQ News
As many pharma manufacturers are rushing to discover the next blockbuster treatment in personalized medicine, the US FDA has approved Kymriah – the first chimeric antigen receptor T cell (CAR-T) therapy. Full Content »
Contributor: Martin Bonney
Posted: 02/05/2017
Mark
The General Data Protection Regulation (“GDPR”) applies from 25 May 2018, and introduces a new set of rules relating to the collection, storage and processing of personal data. Pharmaceutical organisations should prepare for the Regulation in order to remain compliant. Full Content »
Contributor: Pharma IQ News
Posted: 18/10/2016
Pharma IQ News
Following a quarter that featured reports stating that Novartis had dramatically redistributed its cell and gene therapy unit 1 and saw the public focus turn once again to drug price hikes, Pharma IQ brings you the pharma, biotech and life sciences news highlights for Q3 of 2016. Full Content »
Contributor: Pharma IQ
Posted: 19/07/2016
Pharma IQ
As the serialisation industry prepares for various approaching deadlines all over the globe, Pharma IQ has created a printable map to assist with your worldwide track and trace compliance strategies. Full Content »
Contributor: Andrew Love
Posted: 21/06/2016
Andrew Love
In my last article I talked about the need to be responsive to an evolving picture both when selecting your implementation partners but also when working out what is going to be the best solution for meeting the serialisation requirements and including the make-up of your project team. In this next article, covering tips 6, 7 and 8, I talk about the ‘global versus local‘ aspects to consider, the need for flexibility in the design solutions being looked at and finally some important governance principles. Full Content »
Contributor: Pharma IQ
Posted: 14/06/2016
Pharma IQ
As Poland announces plans to create a British-style NHS, a recent paper has proposed that one priority should be to address the potential blurred boundaries between public bureaucracies, politicians and industry providers such as pharmaceutical companies. Full Content »
Contributor: Tony Hitchcock
Posted: 10/05/2016
Tony Hitchcock
Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and still seems to be a long way from a consensus between various end users and manufacturing bodies on how to address this issue. Full Content »
Contributor: Chanice Henry
Posted: 05/05/2016
Chan
When examining the known future for GMP compliance, there are a range of changes that the industry needs to brace for, including a new EU delegated act focused on investigational medicinal products. Here Pharma IQ outlines the GMP updates the market will soon be facing. Full Content »
Contributor: Videojet Technologies Ltd.
Posted: 31/03/2016
Video Jet
Implementation deadlines are looming large, leaving an urgent need for both pharmaceutical and medical device manufacturers to find and implement solutions to stay compliant. With only a few years left to comply with pack level serialization in the US and Europe, the time to complete the changes to existing or new production and packaging lines is rapidly running out. Full Content »
Contributor: Chanice Henry
Posted: 28/04/2016
Chan
While the US advances with its coverage of medical device classes within the U.S. Food and Drug Administration (FDA) Unique Device Identification regime, other countries around the globe are progressing their own track and trace strategies for medical devices. Through the collaboration of the world’s regulatory agencies it is hoped that a synchronized approach to medical device identification will be achieved on an international level, amidst their efforts to tackle counterfeiting, increase accountability and enable safety corrective measures. (2) Full Content »
Contributor: Chanice Henry
Posted: 28/04/2016
Chan
With a view to contribute to the industry’s ongoing progression, Pharma IQ collates the lessons learnt by hospitals during the implementation of UDIs for medical devices and how the conduct of manufacturers and hospitals could be altered to not just optimize this project’s roll out but to avoid incurring any detriment. Full Content »
19 results
of 2
Posted: 30/01/2014
GxP at World Courier: An Interview with Dr. Ruediger Lomb Global Director Quality & Technical Compliance
World Courier’s Dr. Ruediger Lomb, Global Director Quality & Technical Compliance, discusses GxP Compliance in relation to Clinical Supply Solutions. In this interview Dr. Ruediger Lomb covers:What is GxP?How is GxP defined in the transport & logistics Industry?Why is GxP important to World Courier?What steps World Courier have ta Full Video »
Contributor: Andrew Love
Posted: 21/06/2016
Andrew Love
In my last article I talked about the need to be responsive to an evolving picture both when selecting your implementation partners but also when working out what is going to be the best solution for meeting the serialisation requirements and including the make-up of your project team. In this next article, covering tips 6, 7 and 8, I talk about the ‘global versus local‘ aspects to consider, the need for flexibility in the design solutions being looked at and finally some important governance principles. Full Column »
Contributor: Pharma IQ
Posted: 19/07/2016
Pharma IQ
As the serialisation industry prepares for various approaching deadlines all over the globe, Pharma IQ has created a printable map to assist with your worldwide track and trace compliance strategies. Full Whitepaper »