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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

Charles River Laboratories Makes Investments in High-Throughput Screening Infrastructure

WILMINGTON, Mass.--(BUSINESS WIRE)--Feb. 1, 2018-- Charles River Laboratories International, Inc. (NYSE: CRL) today announced a new agreement which grants Charles River commercial access to AstraZeneca’s (NYSE: AZN) high-throughput screening (HTS) and compound management infrastructure. Through the agreement, Charles River will perform HTS programs for its clients utilizing AstraZeneca’s state-of-the-art HTS facility.
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White Papers

The Key To Tableting Success: How To Choose The Right Tooling

Natoli Engineering Company, Inc.

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Industry Events

4th Annual Formulation & Drug Delivery Congress

8-9 May 2018, London, UK

Oxford Global are proud to present our hugely popular 4th Annual Formulation & Drug Delivery Congress, 8th – 9th May 2018, London, UK.Over 300 delegates representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions will gather for over 40 presentations and case studies focused on the key issues in large molecule and small molecule drug formulation and drug delivery.
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