spacer
home > white papers > The EC Definition of a Nanomaterial - Potential Measurement Methodologies - NanoSight
WHITE PAPERS
logo_NanoSightb.jpg

NanoSight

phone +44 (0) 1980 676060
email admin@nanosight.com
web http://www.nanosight.com
email NanoSight Ltd, Minton Park, London Road, Amesbury, Wiltshire SP4 7RT

The EC Definition of a Nanomaterial - Potential Measurement Methodologies

In October 2011 the European Commission published a definition of Nanomaterials. This move followed more than six years of scientific consideration of the potential toxicological and environmental challenges posed by engineered nanomaterials.

spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

‘FDA should withdraw ANDAs’, and ‘new technologies could bring massive improvements in efficiency’ if implemented correctly

Amsterdam, 21st October 2019: CPhI Worldwide – the world’s largest pharma event taking place in Frankfurt (5th-7th November 2019) – has released the first part of its eponymous 2019 Annual Report. Experts Bikash Chatterjee, President and Chief Science Officer at Pharmtech Associates and Girish Malhotra, President of EPCOT International discuss how manufacturing could be revolutionised by new technologies, but warn, that regulators must change to prevent hindering future innovation.
More info >>


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 >>


Industry Events

Clinical Trials Europe | Partnerships, Outsourcing, Operations & Technology

27 August - 21 November 2019, Barcelona, Spain

On 19-21 November 2019, the clinical trial community's most influential stakeholders will be meeting in Barcelona to discuss the evolving landscape, honing in on what it takes to harness true value from partnerships, outsourcing, operations, technology and early clinical development, for a faster, more efficient route to market.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement