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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Winter 2003
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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Industry Insight 
In her Editor's Letter, Dr Patricia Lobo reviews the articles in this issue of PMPS  
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Packaging, Packing & Anti-Counterfeiting
Are the right patients receiving the right drugs in the right dosage at the right time? Eric Tjoa, CEO at Tjoapack BV, reveals all in The Ultimate Solution for Reducing Medication Errors  
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Phil Donaldson, Director of Sales and Marketing at the ALS Group, offers an insight into labelling developments, in Labelling Trends Expand Market Opportunities  
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In Trends in Pharmaceutical Packaging, Bernard C Fenner, Head of Marketing at SIG Pack Systems, looks at future developments in the pharmaceutical sector and the implications for packaging machinery  
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Following the accidental death of a toddler, Jonathan Bobbett, Managing Director at Pill protectTM, highlights the need for improvements, in The Countdown Starts for Implementing New Child-Resistant/Senior-Friendly Blister Packaging  
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In Brand Protection: A Stitch in Time!, Kate Hinsley, Head of Marketing Communications at De La Rue Security Print, argues for improved anti-counterfeiting measures  
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Formulations, Ingredients and Excipients
Dr Detlef Wilke, Partner at Biotech Consulting GmbH and Jens A Katzek, Managing Director of BIO-Mitteldeutschland GmbH, consider plants as alternative eukaryotic expression systems, in Primary Production of Biopharmaceuticals in Plants - An Economically Attractive Choice?  
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In Standardised Extracts and Traditional Herbal Remedies Versus Pharmaceutical Drugs, Andrea Zangara, Research Associate, Jessica Goford, Lead Senior Research Associate and Tamsin Manktelow, Scientific Development Manager at Cognitive Drug Research, discuss the reasons why natural products tend to have less evidence to support their efficacy than commercial drugs  
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In the near future Britain should become the first country to license a cannabis-based pharmaceutical. David Potter at GW Pharmaceuticals, offers his expertise, in Medicinal Cannabis Production - The Botanist's View  
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Dr Trevor Theobald, Business Development Director, Indira Walker, Quality and Regulatory Affairs Director and Dr Christopher Stewart, Botanical Sourcing Manager at Kings, examine why every company using plant-based ingredients in their products faces a number of sourcing challenges, in Quality and Risk Management in Botanical Supply Chains  
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STERILE MANUFACTURING
New Developments in the Containment of Pharmaceutical Powders are identified and discussed by Martyn Ryder, Managing Director of Extract Technology, part of the Carlisle Life Sciences Group  
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Richard Paley, Principal Architect and Pharmaceutical Consultant at Bovis Lend Lease, gives an insight into the complex process of cleanroom design, in Designing Biopharma and Pharmaceutical Cleanrooms  
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Drug Delivery
Advancements in biotechnology and bioprocessing are driving the rapid development, commercialisation and availability of biopharmaceuticals globally, as explained in Reinventing Biopharmaceutical Manufacturing with Single-Use Disposable Systems, by Carolyn Franceschi, Medical Business Unit Manager at Colder Products Company  
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Jon Tuckwell, Head of Drug Delivery at Cambridge Consultants, considers the options available to patients in Dry Powder Inhalers - The Best Alternative Drug Delivery Method?  
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In Taking Nasal Drug Delivery Seriously: Examples of Pain-Free and User-Friendly Alternatives, Pierre Carlotti, Marketing Director at Valois Pharmaceutical Division, explores the direct transport of drugs from the nasal cavity to the central nervous system  
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MANUFACTURING
In Manufacturing Hazardous Biologicals: Practical Considerations, Dr Howard S Tranter of the Health Protection Agency assesses why particular attention should be made to assessing the hazards and risks posed to process operator safety during their manufacture  
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The conservative approach taken to evaluate and qualify water systems used for aseptic pharmaceutical manufacturing, as regulated by the FDA, is discussed by Hank Hicks, Validation Director and David Bosch, Validation Manager, at Pharmaceutical Systems, in Aseptic Pharmaceutical Manufacturing: The Design and Validation of Water for Injection Systems  
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Adrian Howson, Managing Consultant in Health Care Process Development at PA Consulting Group, identifies key concerns and offers practical solutions, in Why the Health Care Industry Needs a New Approach to Automated Testing  
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Vertical and Horizontal Integration Offers Supplier Partnerships in Drug Development and Manufacturing - Gerrit van den Dool, Vice President, Europe at Sigma-Aldrich Inc, reflects on the pharma supply industry's transition from being a smaller niche player to a key partner providing a single source of supply
 
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Risks associated with the operation of isolators, microbials and particulate contamination used for aseptic processing activities are highlighted by Tim Sandle, Microbiologist at Bio Products Laboratory (BPL), in General Considerations for the Risk Assessment of Isolators used for Aseptic Processes  
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In an interview with Maurice Wolridge, CEO of FAMAR, Patricia Lobo, Editor of PMPS and Senior Consultant at Technomark Consulting Services, asks about The Future of Manufacturing - Is Outsourcing the Solution?  
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LOGISTICS
Jamie French, Operations Manager at Biocair, identifies the key issues logistics providers must tackle in order to satisfy client's expectations of more efficient and successful trials, in Clinical Trials - Meeting the Logistics Challenge  
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According to analysts, the pharmaceutical industry will soon be increasing investments in manufacturing automation and information systems. Edwin Mus, Technical Director at Stevo ICT Tools BV investigates, in the True Benefits of Manufacturing Information Systems through Vast Integration  
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In Validation - Walk the Talk, Bash Hemani, Managing Director at C4Consulting and Stig Werner, Senior Validation Manager for Europe Pharma Companies, pose the question: does your validation processes measure up?  
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Peter Van Buren, Sales Director at Introtech bv and Co-Director at Blanken Controls bv, discusses Monitoring Pharmaceuticals During Storing, Handling and Transportation by Means of Indicators  
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Paul Mayer, Sales Director at Braby, invites you to Take the Hassle Out of Buying a Vessel  
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In Success Factors for the Cargo Transportation of Pharmaceuticals, PMPS talks to Francis Ramuz, Cool Products Specialist at Swiss WorldCargo  
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REVIEW
Is Pharmaceutical Manufacturing now a Contracting Business Proposition? Dr Charles E Horth, Life Science Consulting Editor, reports on the 8th Annual 'Vision in Business' Conference on Contract Manufacturing, 2003  
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development
Published quarterly in
February, May,
August and November

News and Press Releases

Rexam Healthcare Devices becomes Nemera and renews its commitment to patients and customers

It was announced today that the healthcare business formerly known as Rexam Healthcare Devices has become Nemera. This name change follows the May 2, 2014 acquisition by Montagu Private Equity. Nemera will continue to operate with the same management team and its choice of name signifies a renewed commitment to its mission of providing patients with safe and accurate delivery devices.
More info >>

White Papers

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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Industry Events

Advances in Cancer Immunotherapies 2014 (ACI2014)

15-16 October 2014, Singapore

Approximately 12.5 million new cases of cancer are being diagnosed worldwide each year, making cancer a new global pandemic with huge economic impact on the healthcare industry.
More info >>

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