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PUBLICATIONS

European Pharmaceutical Contractor

epc
Summer 2009
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

The imminent 'patent cliff' and the global economic problems are forcing pharma companies to change in order to survive. Michael Steiner at RegentAtlantic Capital suggests that focusing on risk management may be a solution.

 
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Georg Mathis at Appletree Ltd discusses the complex dynamics of partnership, explaning the four critical factors that need to be considered in order to create a successful alliance, and taking account of all the elements that make up a 'strategic fit'.  
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Saving money was once considered the primary incentive for conducting trials in the Asia Pacific region. Today, however, the main attractions are likely to be the highly trained and experienced staff, larger patient pools and state-of-the-art technology, as Mukhtar Ahmed at Medidata Solutions Worldwide reports.  
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Legal & Regulatory
The development and use of medicines for children entails particular problems and concerns. Philippa Smit-Marshall at PharmaNet looks at the area from a regulatory point of view, exploring ways of providing information and safety provision.  
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Clinical Development
Margherita Mosconi and Davide Garrisi at CROM guide us through the process of selecting investigational sites, explaining how to use questionnaires and feedback effectively, and highlighting the importance of asking the right questions.  
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A concerning number of marketing authorisations for medicinal products have been withdrawn or suspended in recent years. Peter Schüler at ICON Clinical Research looks at ways of improving drug safety assessment in the clinical research process.  
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James Mundt, Alan Gelenberg and John Greist at Healthcare Technology Systems, Inc discuss methods of suicidality monitoring in pharmaceutical registration trials.

 
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With more than 2,500 years of clinical trials experience, the Middle East offers considerable advantages for CROs, as well as unique challenges. Nadia Cheaib at ClinServ International gives us an insider's view, highlighting the practical and regulatory incentives for working in the region.  
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Efficiency in clinical trials is more crucial than ever in the current financial climate. Lidia Gomenyuk of Dila explores methods of optimisation, with a particular focus on the favourable economic conditions in Ukraine.  
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Idisputably one of the most important priorities in clinical development is the need to find methods of demonstrating the safety of new products faster, with more certainty and at a lower cost. Stefano Persiani of Rottapharm shows how the analysis of drug-drug interactions is a key step towards this objective.

 
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Data Management & IT Solutions
Collecting and managing patient reported outcomes electronically brings significant advantages in terms of time-saving, compliance and data quality. Despite this, there are certain hurdles that need to be overcome in order to enjoy the full benefits of ePRO, says Joy Hebert at .assisTek.  
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Charles Mathis of LORENZ Life Sciences Group looks back at the evolution of eSubmission since the 1980s, and predicts what the future holds for this now indispensible technology.  
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LABS & Logistics
Those involved in the storage and transport of temperature-sensitive products have had to adapt to evolving guidance affecting the area. Chris Fore at Envirotainer reports on this exciting time for cool chain logistics.  
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Simply having the right material in the right place at the right time is no longer sufficient in clinical trial supply management. Nikki Dowlman at Perceptive Informatics looks ahead to the next generation of eClinical solutions, which is able to reduce waste, conform to regualtions and deal with increasingly complex supply chain structures.

 
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ECG CORE LABS & CARDIAC SAFETY
The prospects for cardiovascular drug development have lately been called into question, but it is far too soon to call time, say Koos Burggraaf and Matthijs Moerland at the Centre for Human Drug Research  
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Sasha Latypova and Michael Totterman at iCardiac examine the need to ensure that drug candidates do not have a significant effect on QT interval in the light of recent US and European regulations on the subject.  
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Drug Discovery
Stefan Przyborski of Reinnervate Ltd reports on the development of new compounds which can control stem cell differentation. This, in turn, can play a key role in the evaluation of test compounds at an early stage in the development process, reducing the chances of investing in compounds which will go on to fail.  
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High performance liquid chromatography (HPLC) has a wide variety of uses, and is one of the principal analytical procedures used throughout the drug development and manufacturing process. Erik A Baltussen and Theo HM Noij at NOTOX BV examine the latest developments in the technique.  
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News and Press Releases

Clinical Trial Supply West Coast Conference 2019

Philadelphia, USA – April 24, 2019. This year’s Clinical Trial Supply West Coast Conference will see leading biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) showcasing its specialist clinical trials expertise in relation to scheduled drugs.
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White Papers

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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Industry Events

CPhI & P-MEC China

18-20 June 2019, SNIEC, Shanghai, China

CPhI & P-MEC China 2019 is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new business or getting the latest market insight, this is your one-stop shop pharmaceutical platform in Asia.
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