Cold Chain IQ Editor.
If you were handed with a notice for a clinical trial inspection plan right now, how would you react? - With a feeling of asserted confidence or a rush of slight concern? Wherever you think you would stand on this spectrum, use this infographic to learn from your peers’ mistakes. Pharma IQ invites the expertise of Andy Fisher Senior GCP Inspector... Read more
The transition from paper to electronic Trial Master File (TMF) system, is a significant task, which is further complicated with the varying views and opinions complicating the route to standardisation. This is partially solved by the new directives under construction alongside the EMA’s updated information providing giving insight into inspector’... Read more
The level of process efficiency behind today’s cell and gene therapies is said to rest at a low. The manufacturing behind them is mostly manual, due to the treatments mostly being within early development stages. There are, however, some cases where companies utilise partly automated solutions.
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.
Pharma IQ has compiled this resource booklet containing presentations held at the 2015 Medical Device UDIs and Traceability conference on the following subjects: GUDID – The Data Gathering and Maintenance Challenges Re-thinking Your Labelling Processes and Getting the Buy-in from All Stakeholders Evaluating and Determining the Key Components... Read more
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... Read more
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.
In order to examine the therapy which has been labelled as a game changing addition to oncology, earlier this month industry stakeholders met to explore the evidenced potential of immune checkpoint modulation therapies. The two day conference also saw attendees discuss and formulate tactics to scale the roadblocks encountered by the therapy.
Jeff Carrico, Director of Pharmacy - Investigational Drug Service at Florida Hospital System and Member, Expert Committee, Packaging and Distribution, U.S. Pharmacopeia provides an overview of overarching chapters on Good Distribution Practices.
Lisa Callinan, Research Director - Supply Chain, Gartner explores How Life Sciences Companies Evolve their Logistics Functions to Provide A Competitive Advantage.