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White Papers

Pharma is devoted to providing pharma professionals with the most comprehensive selection of case studies and white papers on the internet. Get in-depth information through Pharma IQ's pharma and biotechnology white papers. Our white papers aim to educate industry leaders as they make complex business decisions that drive growth, innovation and ROI. 

340 whitepaper results
of 33
UDi

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, Planning and Execution of a UDI Project These presentations drill down and examine each of the above challenges in great detail and assess the strategies that can address them.Learn more

EU UDI

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)Learn more

Hos UDI

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.Learn more

adetns

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now.Learn more

UPC

Kevin Mooney– Chairman Drafting committee for the Rules of Procedure for the United Patent Court discusses the pharmaceutical sector in relevance to the changing landscape attached to the UPC and how this will influence the industry. Also, refreshed litigation strategies are analysed as firms look to avoid preemptive strikes from third parties.Learn more

Vjet whitepaper

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.Learn more

bio infographic

On the route to creating new therapeutics for patients, pharma firms require access a range of diverse biological samples. However, one challenge for the market is locating collaborations that will provide a channel to diverse and high quality samples. This is mirrored by the intentions of both public biobanks and academic or hospital biobanks which have a strong focus on hosting and distributing good quality samples that are of high usability in the eyes of biopharma firms.Learn more

scale

One key point of focus is not only the move towards scaling up - manufacturing bigger batches of product- but also scaling out - manufacturing more batches. In response, to this Pharma IQ spoke to Elena Meurer of apceth GmbH & Co.KG to compile this best practise guide automation scale up –and scale out for cell and gene therapies.Learn more

o

As ageing compound management systems need to be renewed or replaced and market practices advance, companies are faced with different options from outsourcing to investing in new technologies in order to maintain momentum.Learn more

icic

Pharma IQ dissects the challenges and identifies the latest developments in regards to improving clinical outcomes for faster approvals with immune checkpoint inhibitors.Learn more

340 whitepaper results
of 33