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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A concerning number of marketing authorisations for medicinal products have been withdrawn or suspended in recent years.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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August and November

News and Press Releases

Strategic Alliance to support efficient, ethical practices in biopharma industry

Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC, a leading Compliance and Ethics solutions consultancy based in the US, and NDA Group, a world-leading integrated regulatory/drug development consultancy, are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
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White Papers

Pharmaceutical Companies: Outsourcing Combination Product Manufacturing

Phillips-Medisize

Combination products are therapeutics that combine two or more products (drug/device, biologics/device, biologics/drugs, or drug/device/biologics), regulated and sold as a single unit. Examples of combination products include drug-coated implantable devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
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Industry Events

PREP 2018: 31st International Symposium and Exhibit on Preparative and Process Chromatography

8-11 July 2018, Hyatt Regency in the Baltimore Inner Harbor, MD, USA

The PREP series of symposia is the most recognized international conference devoted to advances in separation technologies in the field of preparative and process chromatography. Join us for a dynamic and innovative program where experts from around the world will address the latest developments and hottest topics in preparative and process chromatography.
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