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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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News and Press Releases

NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA Europe in Basel

Today NDA Group announced their findings from its fifth annual comparison of drug approvals in Europe and the United States, in preparation for this year’s DIA Europe in Basel, Switzerland. The figures highlight the continued differences between the two regions, and the need for a global approach to drug development to ensure success across both continents.
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White Papers

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Industry Events

BioProcess International European Summit

23-25 April 2018, RAI, Amsterdam

Bringing together 900+ attendees from all major departments in bioprocessing: Cell Culture, Downstream, Manufacturing, Vaccines, Viral Safety and Cell Line Development this April in Amsterdam, Europe’s largest bioprocessing event BPI Europe 2018 will provide you with the latest advice on how optimise bioprocessing through connecting science, technology and business.
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