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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-Wise’s 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 year’s 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. KCR’s Adrian Olszewski introduces two reliable packages to support evidencebased research on drugs.


 
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February, May,
August and November

News and Press Releases

RWS Life Sciences Welcomes New VP of Quality

RWS Life Sciences welcomes Clarice Streets, ASQ, CMQ, OE, as Vice President, Global Quality and Process, in charge of the strategic direction and implementation of its Quality system, underlying organizational processes, and change management.
More info >>

White Papers

Case Study: Emerade® Auto-Injector

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Industry Events

Outsourcing Clinical Trials Nordics 2018

30-31 October 2018, Copenhagen, Denmark

Following on from the success of the 2017 Outsourcing in Clinical Trials Nordics conference, Arena International is pleased to announce that the event will return for its 6th year in 2018. The 2018 event welcomes biopharmaceutical and medical device companies from across the Nordic region to share knowledge and challenges of outsourcing and clinical operations.
More info >>

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