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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
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August and November

News and Press Releases

Horizon Discovery and Fulcrum Therapeutics Form Collaboration for Novel CRISPR-Based Target Discovery in Genetic Diseases

The collaboration will utilize Horizon’s world-leading CRISPR-based screening platform to identify novel targets for regulating gene expression.
More info >>

White Papers

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
More info >>

Industry Events

7th annual Orphan Drugs and Rare Diseases UK

18-19 October 2017, Holiday Inn Kensington Forum, London

SMi Group is thrilled to present the 7th annual Orphan Drugs and Rare Diseases conference, taking place on 18th & 19th October 2017 in Central London, UK. This year’s theme will be focused towards discussing strategies for patient engagement, market access and gene therapies to enhance rare diseases and orphan drug research.
More info >>

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