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.
Dr Graham Hughes,
Published quarterly in
September and December
9-10 February 2015, Holiday Inn Regents Park Hotel, London, UK
regulatory regimes for pharmaceuticals result in significant differences in
pharmaceutical prices across countries. These prices make it profitable for
parallel trade to take place in addition to it reaching a significant
proportion of total national pharmaceutical expenditure in many European
countries. More info >>
Great Success for the First European Edition of The Dieline Summit
Launched jointly by the international EMBALLAGE exhibition (Comexposium)
and THE DIELINE.COM, the first edition of "The Dieline Summit" was held
at the Palais des Congrès in Paris on the 16th and 17th November. More info >>
Points to Consider When Developing a TMF (Trial Master File) Strategy
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 >>