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Pharmaceutical Manufacturing and Packing Sourcer |
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| At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. PMPS provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in this issue of PMPS |
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| In her Editor's Letter, Dr Patricia Lobo reviews the articles in this issue of PMPS |
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| Emmanuel Dimotakis, PhD and Robert A Nash PhD, Department of Chemical and Pharmaceutical Engineering, New Jersey Institute of Technology, provide a review of matrix and coating systems, in Modified-Release Oral Solid Dosage Forms - Part I: Coating and Matrix Formation |
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| The choice of excipient is extremely critical in formulating direct compression tablets. In Starch Based Excipients for Tabletting, Dr Jacques Michaud, Business Manager Pharma & Cosmetics at Cerestar, considers the suitability of various excipients for direct compression |
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| In Improving the Clinical Trial Supply Chain by Using Best Practice Techniques, Harald Geimer and Frank Schulze at PRTM, explore how better manufacturing and supply processes can make the difference between a smooth clinical trial and a costly debacle |
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| Today's CTS business is a microcosm of the wider pharmaceutical industry. In Clinical Trial Supplies - The Essential Link, Dr Patricia Lobo, Editor of PMPS, reviews some aspects of the modern CTS business |
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| Bob Clark, Solutions Consultant with the Logos Group of Companies, considers inconsistent use of terminology, quality management and translation, in Taking Control of your Terminology |
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| In The Financial and Operational Benefits of e-Learning in Regulatory Compliance, Chakri Lokapriya, Managing Consultant - Compliance Solutions, and Tony Kypreos, Chief Commercial Officer, at Maersk Data UK, explain why e-learning will improve operational efficiency and profitability |
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| The need to unify automation and information systems has led to the development of a collaborative software architecture. In Putting All The Wood Behind One Arrowhead, Mark Davidson, Vice President of ArchestrA Marketing for Invensys Production Management, examines the results |
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| Tom Lewis, Managing Director of VISiTEMP Limited, answers the question: why do we need temperature data loggers? in Temperature Data Logging - A Primer |
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| In Improving Efficiency and Reducing Costs - What Part Do Information Systems Play? Geoff Parker, Commercial Director at Scimcon, suggests a review of information systems to improve efficiency |
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| Competition in the pharmaceutical industry has intensified and companies must minimise IT downtime to stay ahead of the competition. Russell Flower, Strategy Director at Synstar, explores the components of a global business availability programme, in Are You Available? |
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| In The Environmental Impact of Metered Dose Inhalers, Cees Winnips MD, Director of Business Development at SkyePharma AG examines the development of CFC-free alternatives to MDIs |
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| The aim of developing FIDS is to achieve enhanced performance from drugs. Professor John N Staniforth, Chief Scientific Officer at Vectura Ltd, outlines the benefits, in Formulation Integrated Device Systems for Novel Enhanced Performance Products |
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| Sarah Creeke, Andrew Gill, Phil Seeney and Rod Smith, Consultants at PA Consulting group, discuss the performance of dry powder inhalers, in Keep Your Powder Dry |
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| In Nasal Delivery of Vaccines, Dr Per Gisle Djupesland, Founder, Head of R&D and Chairman of OptiNose AS, highlights the advantages of nasal delivery as an attractive alternative to injection |
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| Mohan Sasthav PhD, Segment Manager, Packaging, MeadWestvaco Packaging Resources Group, suggests how advanced barrier protection will improve well-being, in The Barrier Essentials |
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| In Packaging - The Future in 3D, Nic Hunt, Global Business Director for Rexam Pharma Flexibles and Rexam Pharma Services, predicts a revolution in virtual packaging design |
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| The closure system used in the packaging of an active substance must be justified for its intended use. Kirsten Nielsen MSc, Head of the Pharmaceutical Packaging Development Department at LEO Pharma A/S, outlines the formula for Packaging for Stability Testing of Active Substances |
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| David Tebworth, Marketing Services Manger at DS Smith Tri-Wall, illustrates aspects of intelligent packaging solutions through all stages of development, focusing on dry flowables, in Intelligent Packaging Solutions for the Distribution of Bulk Chemicals and Pharmaceuticals |
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| In Label Materials For Small Diameter Applications, Sven Tolsma, Product Manager at Raflatac, considers the trend towards smaller diameter packaging and the challenge of labelling these products |
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| The validation of disinfectants for use in controlled environments can be both lengthy and expensive. In The Scope of Validation for Cleanroom Disinfectants, Andrew Davidson, Commercial Director of Shield Medicare Ltd, examines how to ensure a smooth and successful outcome |
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| Martyn Ryder, Managing Director of Extract Technology, explores the need for effective dust containment when handling APIs, in Containment Solutions: Solids Charging into Process Vessels |
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| In Acrylic Finishes Wipe the Floor in Hygiene Stakes, Tony Blackman, Technical Manager of Acrylicon, explains the advantages of a new generation of acrylic flooring for cleanrooms |
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News and Press Releases |
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SHIONOGI’S NOVEL ANTIBIOTIC, FETCROJA® (CEFIDEROCOL), HAS BEEN SELECTED BY UK’S NICE / NHSE&I AS PART OF AN ANTIMICROBIAL SUBSCRIPTION STYLE REIMBURSEMENT MODEL
The National Institute for Clinical and Health Excellence (NICE) and the National Health Service England and Improvement (NHSE&I) have recognised the potential of Shionogi’s innovative antibiotic, cefiderocol, and selected it for inclusion in this pilot reimbursement model which ‘de-links’ payment from volume of use
Shionogi recognises the UK’s leadership role in introducing this first fully ‘delinked’ pilot reimbursement model, which is an important step in making the market for novel antibiotics more predictable and sustainable; we strongly believe in the introduction of further suitable pull incentives in order to help stimulate the antimicrobial development pipeline
Fetcroja® (cefiderocol) is indicated for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options1
Antimicrobial resistance (AMR) is a major health burden which results in over 700,000 deaths globally2 and 5,000 deaths per year in the UK3 from an infection with multidrug-resistant bacteria and this is predicted to kill 10 million people every year globally by 2050, unless action is taken2
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White Papers |
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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