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European Pharmaceutical Contractor

epc
Autumn 2008
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC 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 the current issue of EPC.
   
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Marketplace & Business
Advanced eClinical technology can help the pharmaceutical industry to improve productivity and reduce costs in order to meet the demands of a difficult marketplace environment, explains Wade Wirta at Perceptive Informatics  
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There’s no competitive advantage in submissions management, so why be dragged down by the process? Adam Sherlock of ISI says it is time to let someone else do it  
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Margaret Osborn of Synergy Marketing Group, Inc, applies the power of electronic marketing and demonstrates the ways in which it drives awareness, demand and leads  
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Jane Nathan at PharmaEd emphasises the importance of appropriate medical training for clinical teams  
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Legal & Regulatory
Colin Bell at Brabners Chaffe Street discusses the need for effective IP strategies for pharmaceutical innovations  
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Claire Madden-Smith at Molecular Profiles examines the most effective lifecycle management strategies and the role of intellectual property  
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Philip Payne at RSSL Pharma believes that for any company working in the pharmaceutical industry complying with the regulations and guidelines issued by any of the regulatory bodies represents both a commitment and a challenge  
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Clinical Development
Joop van Gerven and Justin Hay of CHDR discuss how carefully chosen biomarkers can easily be incorporated into early phase drug studies, providing guidance for important decisions concerning a drug’s future  
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Lisa L Mathis at the Paediatric and Maternal Health Staff Office of New Drugs, FDA, argues the case for better paediatric drug testing  
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Graham Wylie of the MRN discusses the use of clinical trial support organisations (CTSOs) for home-based drug administration in clinical trials with parenteral therapies  
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Janet Edwards of AstraZeneca explores how partnership and innovation works for global clinical development  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Peter Gaskin at Aptuit Consulting assesses the failure of neuroprotectives in the clinic and questions whether the lessons can be applied to the design of animal models for other CNS indications  
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Natalie Appels and Ilona Verbaan-Giebelen of NOTOX BV propose in vitro testing alternatives for designing a better preclinical and clinical package, reducing animal use and drug development costs  
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In liquid handling quality assurance, location is vital for improving quality in drug discovery and development processes, claims George Rodrigues at ARTEL  
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Data Management & IT Solutions
Is electronic data capture standardisation the next evolution in clinical trial productivity? Simon Hawken of eResearchTechnology, Inc explores this faster and cheaper method for data collection  
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LABS & Logistics
Intelligent automation and control solutions can optimise manufacturing performance and safeguard product quality, claims Walfried Laibacher of Honeywell Building Solutions  
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Don Riach at Marken outlines the challenges of temperature controlled pharmaceutical logistics and the role of the specialist courier company  
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Hermann Schulz of INTERLAB GmbH provides an update on the logistics of shipping biological samples across borders  
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ECG CORE LABS & CARDIAC SAFETY
James Conklin of ICON Medical Imaging charts the evolution of commercial imaging core laboratory technology systems  
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Published quarterly in
February, May,
August, and November

News and Press Releases

MedPharm Expands Relationship With Novan On Formulation Science

MedPharm Ltd, a leader in topical and transdermal drug delivery, has expanded its relationship with the NASDAQ listed biopharmaceutical company Novan Inc. MedPharm has previously supported Novan by testing the company’s unique formulations using its proprietary in vitro models to optimise Novan’s formulations and de-risk product development.
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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

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
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