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PUBLICATIONS

European Pharmaceutical Contractor

 

European Pharmaceutical Contractor (EPC) is designed to fill a unique position in pharmaceutical publishing. Providing a dedicated platform of communication and information for the international pharmaceutical contract market, it consists of a series of articles and case studies written by eminent figures in contractor groups and traditional multinational pharmaceutical companies.

Each quarterly edition examines areas of importance – both economic and technical – to contract research organisations, contract manufacturers, regulatory controllers, consultants and analysts. This enables regulatory bodies to link directly with policy-makers both in major contractor groups and pharmaceutical companies, and thereby convey regulatory information directly from the governing bodies, but also ensure debate between the policy-makers and consultancy groups.

 

For further information please contact:

Advertising
Dean Dalton

Editorial
Aimee-Rose O'Driscoll

We're also on Twitter! Follow us @EPCmagazine

Read our publications on the go in the Samedan app for iPhone and iPad. You can download issues for offline reading and our archives go as far back as 2008! Download for free on the App Store.


View the digital version of EPC




 

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Featured in this issue
Legal & Regulatory
Proposed EU Data Protection Regulation

Potential Impact


This year, the European Parliament put forward a new regulation on data protection. Samantha Regenthal of Regenthal Legal & Compliance outlines the impact the legislation could have on the industry if implemented.

Regional Focus
Russia Focus: Risk-Based Monitoring

Instant Results


While there are huge cost savings to be had from implementing risk-based monitoring, the benefits can take years to surface. Synergy Research Group’s Igor Stefanov and John Barker offer Russia as a solution to those looking for quicker rewards.
  Labs & Logistics
Laboratory Relocation

The Right Move


Potential research disruption, damage to samples and heavy costs can strike fear into any company considering a laboratory move. John Best at Andrew Porter Ltd tells us how to make a success of any relocation.

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Edited by
Dr Graham Hughes,
Consultant in
Pharmaceutical
Development
Published quarterly in
March, June,
September and December
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Industry Events

SCOPE Summit 2015

24-26 February 2015, Orlando, FL

The 6th Annual SCOPE Summit, taking place February 24-26, 2015 in Orlando, FL, will offer three stimulating days of in-depth discussions in 12 different conferences focused on issues related to each aspect of clinical trial planning and management...
More info >>

 
News and Press Releases

Woodley Equipment Company Exhibiting at Partnerships in Clinical Trials Congress, Barcelona

Woodley Equipment is exhibiting at Partnerships in Clinical Trials Congress, which is taking place on 5th to 6th November 2014 at the CCIB, Barcelona, Spain. Woodley is a specialist global supplier of medical and laboratory equipment solutions to the Clinical Trials Industry and is the partner of choice of many of the largest companies in Clinical Research.
More info >>

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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.
More info >>

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