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PUBLICATIONS

European Pharmaceutical Contractor

epc
Summer 2015

   
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introduction
Editor’s Letter

Graham Hughes homes in on the theme of patient protection in this issue, and discusses the features that have a regional focus.
 
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Marketplace & Business
Sponsor Marketplace

Time Trial

Karyn Korieth and Annick Anderson at CenterWatch put forward their company's analysis to highlight the huge variablility in sponsors' drug timelines - and across certain therapeutic areas - while advising on how developers can get up to speed.

 
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Market Entry

The American Dream


AmeriStart's Jim Worrell outlines how to go about breaking into the US market. He believes willing investment, innovation, patience and well-thought out decisions are crucial to seizing the opportunities on offer.

 
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Strategic Partnerships

Balancing Act


Graham Wylie at the Medical Research Network argues that true strategic partnerships rarely exist. As industry mindsets and outsourcing models alter, balancing the risks and rewards of a collaboration are key to its success.
 
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Legal & Regulatory
Vulnerable Populations

Patient Protection

Investigators' main priority should be ensuring the safety of patients, especially those in vulnerable populations. Theorem Clinical Research's Marc Hoffman summarises the stringent measures required to guard those who are most at risk.


 
 
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European Regulation

Within REACH


The deadline for compliance may be over two years away, but meeting REACH's chemicals standards is a resource-heavy task. So much so, in fact, that Jeannette Paulussen at WIL Research advocates enlisting external support to alleviate the burden.

 
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Anti-Bribery and Corruption

Prevention is Better Than Cure

If adequate defences are not implemented to prevent bribery, a company can be charged despite having no prior knowledge of an offence. Therefore, as Catriona Munro of Maclay Murray & Spens LLP underlines, pharma must be seen to be doing everything it can to avert such incidents.
 
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Intellectual Property

Expiry Date


Pharmaceutical marketing increasingly requires a long-term proposal, as Tina Rees-Pedlar at Marks & Clerk points out. With a solid plan in place, businesses can gain revenue from their products long past the patent expiry date.
 
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Clinical Development
505(b)(2) Pathway

Beyond the Cliff

Ken Phelps at Camargo Pharmaceutical Services offers a solution to the pharma cliff in the form of the FDA’s 505(b)(2) pathway. As the amount of drugs going off-patent diminishes, this route to approval can help generic companies boost revenue.





 
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Causality Assessments

Facing Adversity


Usually identified using the WHO's criteria, adverse drug reactions - and their causal relationships with products - are vital in preventing potential harm to study participants. But there are more reliable assessment methods available, claim Maxim Kosov, John Riefler and Maxim Belotserkovskiy of PSI CRO.

 
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IT Solutions
Information Management

Single Source

Storing information across multiple systems often results in time-consuming and error-prone clinical processes. Devising a single source of content adds visibility and control, which translates into faster therapy development, reasons Rik van Mol of Veeva Systems.
 
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Therapeutics
Variant Creutzfelt-Jakob Disease

Potential Prognosis

The number of people carrying variant Creutzfelt-Jakob disease is potentially huge – however, due to a lack of diagnostic tools, the total is unknown. EPC Industry Advisor Shelley Bowers sheds light on the ethical issues that may inhibit testing, even if more appropriate methods are found.
 
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Manufacturing Environment
Cytotoxic Injectables

Contract Capacity


Unless it currently exists or is already planned for, the capacity for the contract manufacture of cytotoxic injectables is likely to remain at a standstill. Jim Miller and Saul Richmond of PharmSource take us through the many barriers restricting progress in this area.
 
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Regional Focus
Clinical Research: Turkey

Land of Opportunity


At the centre of an emerging region, Turkey boasts a supportive regulatory framework, a large number of sites and diverse patients, and a competive cost structure. Ömer Sadun Okyaltırık and Yamin Khan of Pharm-Olam report.

 
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Interview
Q&A: Vaccines

Immune Response


Drawing on her 30 years spent in the research arena, Cynthia Dukes at ICON assesses the future of vaccines and the technologies used in their development.
 
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Industry Interview

Comply and Demand

Synergy Research Group’s Igor Stefanov and Yuri Afonchikov talk to EPC about standing out in the CRO crowd and their experience of Good Clinical Practice failings.
 
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Outsourcing
Outsourcing and Insurance

Risk and Reward

As global outsourcing continues to expand, Marsh’s Simon Thompson recommends that insurers capitalise on new gaps in the life sciences market, created by the evolving threats this trend brings.
 
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Mobile Devices
mHealth

Mobile Future


MEDL Mobile’s Dave Swartz questions why some pharma firms are still hesitant to utilise mobile technology. Its immense benefits are evident, he claims, emphasising that this is only the beginning of the journey.
 
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In Conclusion
In Conclusion

The Path to Prevention


Can finding a cure have the opposite of the desired effect? Graham Hughes explores the landscape of contagious and deadly diseases.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Nemera organized an expert review on the present and future of inhalation products

“Connectivity in every new inhalation device?” This topic was one of those discussed with different inhalation experts - Manfred Keller, Pascal Cavaillon and Henry Chrystyn – during a round table organized by Nemera in Paris to review the advantages and limitations of inhalation devices.
More info >>

White Papers

Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control

Berlinger & Co AG

There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
More info >>

Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

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