At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. PMPS 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 this issue of PMPS.
X-Ray systems are becoming increasingly valued by the pharmaceutical industry as an indispensable
means of non-destructive testing; Martin Allen of Shaw Inspection Systems takes a closer look
The automated CheckWeighing system for dry powder inhalers supports
the quality assurance process, outlines James Aitken of Aitken Scientific
Elisabethann Wright of Hogan & Hartson Brussels consider the European Commision’s attempts
to strengthen the legal framework for regulating medical devices in Europe
Tom Roche at FM Global assesses how a single incident in one country
can have a disastrous impact on the entire global economy
Frances L DeGrazio at West Pharmaceutical Services, Inc, outlines the procedures involved
and the importance of thorough testing in the leachables and extractables field
Stephen Grant at ANSYS discusses how computational fluid dynamics (CFD)
enable a fast and cost-effective evaluation of new drug delivery systems and formulations
Douglas Custato at Helvoet Pharma outlines the options pharma companies
will be presented with when choosing the ideal elastomeric closure
Andy Wallace at Comark Ltd encourages investment in wireless monitoring
systems – a key tool for those looking to expand into emerging markets
Formulations, Ingredients and Excipients
Many active pharmaceutical ingredients are unstable and subject to degradation.
The role of excipients is therefore being viewed as progressively more
important. Nigel A Langley and Karen H Chen at Croda Inc (USA) explain how.
Dr Robert Hardy of Aesica explains to PMPS that exceptional service and a well-balanced
business model is key in providing contract services to the outsourcing industry
IT and Logistics
Guido Moosmann of Schreiner MediPharm explores the latest
innovative technologies for clinical trial supply management
PACKING, PACKAGING & ANTI-COUNTERFEITING
John Haworth at Ditone Labels looks at how
the pharma packaging industry has responded
to the needs of the blind community
Nicole Golomb at 3S Simons Security Systems GmbH takes us through
the various options available to avoid the counterfeit risk
Low and microdose powder filling in the pharmaceutical industry has traditionally been
a challenging process. However, new developments are on the way, as Robin Davies of Isopak Ltd explains
Robert Kayum at Kuehne + Nagel explores today’s climate for temperature-sensitive logistics,
and the developments in solutions that can transform the role they play in the pharma industry
Chief Technical Officer at Juniper Pharma Services
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News and Press Releases
6th Munich Biomarker Conference 2016
The 6th Munich Biomarker Conference will take place at the end of November
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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.
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