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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 October

News and Press Releases

Gerresheimer Bünde puts a Combined Heat and Power Plant into Operation

Düsseldorf/Bünde, November 21, 2014 - Gerresheimer Bünde GmbH recently put its first combined heat and power plant (CHP) into operation in collaboration with the Westfalen Weser GmbH energy services company. The CHP was manufactured by Sokratherm and it is used for the decentralized production of electrical power and heat according to the heat and power co-generation principle. The 570 HP truck engine at the heart of the plant is gas operated and generates around 400 kWh of electricity. The operation of the engine also generates 520 kWh of heat, which is recovered by a system of heat exchangers and used for heating and hot water supply.
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White Papers

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With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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Industry Events

19th Annual Drug Delivery Partnerships

28-30 January 2015,

Drug Delivery Partnerships (DDP) is hailed as the world's most authoritative conference on drug delivery technology and innovation. DDP is where you discover cutting-edge innovative products, take advantage of delivery trends and jumpstart strategic relationships to leap ahead of the curve.
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