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PUBLICATIONS

European Pharmaceutical Contractor

epc
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

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
More info >>

White Papers

Characterisation of Biopharmaceutical Proteins

Reading Scientific Services Ltd (RSSL)

Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the protein�s primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.
More info >>

Industry Events

LogiPharma 2019

9-11 April 2019, Montreux Music & Convention Centre

LogiPharma is the world’s leading pharma supply chain event. With over 950+ pharma supply chain leaders exclusively meeting in one place at one time, LogiPharma is THE meeting place to benchmark your business with the best pharma companies and shape the future of your industry.
More info >>

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