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European Pharmaceutical Contractor

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Summer 2016

   
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Business and Finance
Payer Negotiation

Coming to Terms

James Thomas
at Seren Partnership assesses the importance of negotiating skills in pharma, and reveals seven vital principles in dealing with payers that will prepare you for success.

 
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Clinical Training and Competence

Are You Qualified?


Competent staff are key to success in every business – this is especially true in pharma, where the stakes are higher. IAOCR’s Martin Robinson explains how competence-based training can aid enormously in further developing clinical research associates’ skills.

 
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Clinical Trials
GCP Compliance

Best of Both Worlds


There is a noticeable divide between clinical and quality, believes Patricia Santos-Serrao at MasterControl, and one of the ways to overcome this is the implementation of good management strategies.

 
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Electronic Trial Master Files

Paperweight Challenge


eTMFs are gaining more and more traction in the management of clinical trials, according to Veeva Systems’ Rik van Mol – it is not surprising, therefore, that demands placed on eTMFs have become increasingly higher.

 
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Clinical Trials Supplies
Sourcing Strategy

Going Local


Comparator drugs are increasingly taking the lead in the pharma supply chain, states Guillaume Brulebois at Fisher Clinical Services, and sourcing these from local markets seems to be the way forward. But is it that simple?

 
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Sourcing and Supply

Setting the Standard


Obtaining non-investigational medicinal products can pose a major challenge to stakeholders. Mary-Jo Lamberti, Josephine Awatin and Ken Getz at Tufts CSDD and Myoderm’s Michael Cohen explore some of the hurdles and share best practices in sourcing comparators.

 
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Spotlight

Demand-Driven Labelling and Distribution: What It Is and Why You May Need It

Clinigen CT
S introduces its new trial management system, designed to improve efficiency and save money for sponsors.

 
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Published quarterly in
February, May,
August and November

News and Press Releases

Mironid Announces Closing of £4.3 million ($6.2 million) Series A Financing

Cell signalling in drug development company today announced the closure of its Series A funding round
More info >>

White Papers

Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test

Wickham Laboratories Limited

Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
More info >>

Industry Events

CPhI Worldwide 2017

24-26 October 2017, Messe Frankfurt, Germany

CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 42,000 visiting pharma professionals over three days. 2,500+ exhibitors from 153 countries gather at the event to network and take advantage of more than 150 free industry seminars. The exhibition covers every sector of the pharmaceutical market under one roof.
More info >>

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