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European Pharmaceutical Contractor

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Autumn 2016

   
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Legal & Regulatory
ICH E6 (R2) Addendum

Game Changer


The new ICH guidance will be implemented in November 2016, which will have a profound effect on the management of clinical trials. Nick Neri at ERT outlines some of the steps that pharma companies need to take in order to remain compliant.
 
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Data De-Identification

Protecting Patient Identities


As organisations are required to become more transparent in their studies, the identities of patients are being put at risk. d-Wiseís Chris Olinger comments on new guidelines trying to alleviate this problem.
 
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Spotlight

The Path to Easier Product Lifecycle Maintenance

TRAC Services
reveals the importance of the regulatory affairs function within pharma, and how good document management is critical in the successful production of drugs.
 
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Regulatory Update

On Duty

Viktoriya Angelova
at Rephine gives an overview of the most significant changes the new ICH Addendum brings, particularly with regards to sponsor and investigator responsibilities.


 
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Reviews & Previews
Event Review

Up to Standard?


A central theme of this yearís DIA annual meeting in Philadelphia, US, was cyber identity and the issues associated with it. Jon Weisberg at SAFE-BioPharma reports.
 
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Data Management & IT Solutions
Biostatistics

SAS and R Team in Clinical Research


To either prove or disprove stated hypotheses, it is necessary to carry out statistical analyses and collect data. KCRís Adrian Olszewski introduces two reliable packages to support evidencebased research on drugs.


 
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News and Press Releases

RWS expands global offering with RWS Life Sciences.

On October 1, 2017 RWS, the world's leading provider of translation, intellectual property, life sciences and language support services, announced a re-launch of its brand, website and divisional structure following a number of successful acquisitions which have significantly extended the groupís capabilities and geographical reach.
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White Papers

PhlexEview: Transforming Costly Paper Processes into Value Driven Compliance

Phlexglobal Ltd

Looking at some of the challenges of traditional paper-based Trial Master Files (TMFs), and how they can be overcome with Phlexglobal's best in breed electronic TMF system, PhlexEview.
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Industry Events

INTERPHEX 2018

17-18 April 2018, Javits Center, New York, USA

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