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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

ChemAxon and AWS simplify getting scientists moving on the cloud

Listen to a talk by Paul Underwood of AWS introducing Biotech Blueprint, a cloud based solution for cheminformatics. The technology for novel compound registration is provided by ChemAxon.
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White Papers

Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences

Myoderm

Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
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Industry Events

SMiís 9th Annual Biosimilars & Biobetters Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Following the success of our previous events in both London and the US, Biosimilars and Biobetters UK 2018, SMi deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.
More info >>

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