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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

Protagen Protein Services (PPS) reaches new level in characterizing HCP protein impurities

In response to current regulatory guidance a Mass Spectrometry (MS) based Host Cell Protein (HCP) detection approach with faster, more accurate and wider-ranging detection is essential. In order to meet the newly prevailing demands Protagen Protein Services (PPS) recently invested in more far-reaching MS capabilities: The new high-performing mass spectrometer ThermoFisher Q Exactive™ HF-X started operational service last month and brings PPS to the next level of reproducible, accurate and sensitive analyses of majorly complex samples for different aspects of translational research and biopharma applications.
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White Papers

Contemporary Issues in Comparator Trial Supply

Clinigen CTS

As trial design and execution becomes ever-more complex, initiatives to adapt, increase efficiency and control costs without compromising quality become paramount. Here, Clinigen CTS covers the broad issues and summarises the responses our industry is making in this increasingly demanding landscape.
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Industry Events

Bio Europe Spring 2019

25-27 March 2019, Messe Wien Exhibition and Congress Center, Vienna

BIO-Europe Spring® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing life science companies with high caliber partnering opportunities. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative startups.
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