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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

Strategic Alliance to support efficient, ethical practices in biopharma industry

Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC, a leading Compliance and Ethics solutions consultancy based in the US, and NDA Group, a world-leading integrated regulatory/drug development consultancy, are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
More info >>

White Papers

Mauritius Island – An Emerging Centre for R&D in Biotechnology and the Life Sciences

CIDP (Centre International de Développement Pharmaceutique)

Mauritius, the tropical island situated in the Indian Ocean and known worldwide for its beautiful beaches, is also internationally recognised for its rule of law, and political and social stability. Over the past few years, the economy has been successfully transitioned from a monocrop to a diversified innovation-driven and knowledge-based economy, resting on agribusiness, export-oriented manufacturing, tourism, financial services, property development and real estate, ICT-BPO, the seafood industry, a free port, logistics and a nascent ocean economy. Emerging sectors such as healthcare and life sciences are presenting some niche areas for the taking, and the enabling environment is being put in place to make it happen - especially in the light of sustained growth within pharmaceutical, medical device, and clinical research. Important international players are already in operation locally as the country has established the appropriate legal and regulatory frameworks based on international norms, for the development of a strong biomedical research sector.
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Industry Events

INTERPHEX 2018

17-18 April 2018, Javits Center, New York, USA

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA).
More info >>

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