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European Pharmaceutical Contractor

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Winter 2010
   
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Marketplace & Business

Tactics and Strategies

The pharmaceutical industry continues to consolidate with many companies looking to lower their costs. Andrew Kelley of Patheon identifies the benefits of seeking partnerships with suppliers when outsourcing, rather than opting for a transactional relationship.

 
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Why Provide Early Market Access?

Who should get early access to medicines and how do we balance patients’ needs with safety concerns? Simon Estcourt of Idis poses some key questions to consider in a discussion on using named patient programmes to provide early access to medicines for patients who most need them.

 
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The Science of Alliance

Brenda Hoeper and Cathy Thompson at i3 Statprobe explore the current marketplace conditions as well as the elements necessary for successful alliances, illustrating this with a case study.

 
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Medical Writing: Outsourcing Guide

Julia Forjanic Klapproth of Trilogy Writing & Consulting highlights the four main stages of outsourcing medical writing, the questions to ask when selecting a company, and how regular communication can save both money and time in the clinical development programme.

 
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Towards Greater Certainty

As regulators, providers and payers demand more evidence of product performance in the real world, a new generation of service providers are emerging in the biopharmaceutical industry, as Ethan D Leder at United BioSource Corporation explains.

 
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The CRO Scene in 2010

EPC’s editor, Graham Hughes, reviews the performance of CROs in 2010, looking at outsourcing trends, the current R&D pipelines and measures to address declining productivity.

 
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SITE SELECTION

Putting Kazakhstan on the Clinical Trials Map

Like any other territory at the beginning of its clinical trial career, Kazakhstan has its strengths and weaknesses. Anna Ravdel and Irina Kim of Synergy Research Group make a case for this CIS state as a new destination for clinical research.

 
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Research in India: Tomorrow and Beyond

India has been a popular destination for clinical trials and, as there is an increasing acceptance of Indian data, Viraj Rajadhyaksha stresses that there is a need to ensure science and operational excellence remain top priorities.

 
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Paediatrics Special Focus: Clinical Development and Regulatory Updates

In Search of Safe and Effective Medicines

Paolo Tomasi at the European Medicines Agency points out that, despite the controversy that still remains regarding the use of children as subjects of scientific studies, significant regulatory changes can make research safer and lead to wider availability of medicines for children.

 
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Paediatric Pioneers

The challenges of developing drugs for rare diseases are well recognised but as pertinent as ever; Karen Aiach of Alliance SANFILIPPO highlights recent progress for Sanfilippo syndrome – an orphan disease affecting only one in 700,000 children.

 
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PIP: Lab Perspectives

Both regulatory authorities and pharmaceutical manufacturers agree on the need for running paediatric studies to reduce the ‘off-label use’ of drugs in children. Katja Neuer-Etscheidt and Hermann Schulz at INTERLAB discuss how using a centralised laboratory can help to streamline this process.

 
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS

Diabetes: Making Strategic Partnerships

Rickey Reinhardt of Covance explains the need for pharma and biotech companies to partner with CROs to develop an integrated drug development strategy as a way of bringing more efficient combination therapies with better side effect profiles to market.

 
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In Search of Innovation

TQT trials are now required in the regulatory process in many countries, according to the ICH’s E14 guidance. Alan Copa of Cetero Research reveals some approaches that can be used to improve the accuracy of TQT trial data, while keeping costs under control.

 
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In the Heart of Russia

In 2009, cardiology represented the fourth largest area of clinical research in Russia and the region ranked 11th internationally in terms of pharmaceutical sales. Lyubov Semenova at Pharm-Olam makes a case for Russia as a leader in global cardiology research.

 
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Data Management & IT Solutions

Flexible LIMS

The implementation of a modern clinical trial LIMS provides many benefits to the clinical development process by allowing quick identification and resolution of queries which helps to increase the value for trial sponsors, reveals Edward Krasovec at STARLIMS.

 
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The Age of EDC

Gregor Spiekermann of Merz Pharmaceuticals GmbH looks at how electronic data capture has progressed over the last 10 years, reviewing today’s challenges and the role that EDC provider partnerships can play.

 
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Integrated Science

LIMS, ELN and SDMS: they play different roles but are they all needed in the lab? Robert Pavlis at Labtronics suggests that real-time integration between these applications is what is most important, and introduces a fourth system – the iLAB, or integrated lab – as the solution.

 
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Cool Chain, Labs & Logistics

A Warmer Reception

Omoshile Clement, Rolf Müller and Judy Müller-Cohn at Biomatrica Inc reveal how ambient temperature-based nucleic acid storage and shipping can potentially offer significant savings compared to current cold-freezing methods.

 
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Securing the Supply Chain

According to the WHO, 25 per cent of all vaccine products arrive at their final destination in a degraded state. Rüdiger Lomb of World Courier recommends that pharmaceutical practitioners select their supply chain service providers with care.

 
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Published quarterly in
February, May,
August and November

News and Press Releases

PCI Pharma Services Announces Release of Joint White Paper with Domino on Ink Leachability in Pharmaceutical Serialization

Leading pharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced the release of a published white paper detailing Domino’s study which analyzes potential leachability of ink from coding technologies used in pharmaceutical Serialization activities. The study was executed to ensure no migration into drug product contained within HDPE bottles with directly applied codes. Domino is an industry leader in coding and printing technologies operating in over 120 countries worldwide, and one of the key providers of coding technologies to PCI across its global supply network.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

Industry Events

LogiMed 2017

18-19 October 2017, Hyperion Hotel, Hamburg

Taking place 18-19th October in Hamburg, LogiMed is Europe’s only dedicated medical device supply chain event bringing together over 150 Medical Device Supply Chain Professionals to network with. With a greater focus on customer collaboration and digital transformation this year’s LogiMed delivers real insights on inventory visibility, supply chain planning, global logistics and digitalization.
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