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European Pharmaceutical Contractor

epc
Winter 2016

   
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Business and Finance
Drug Prices

Adding Value


Putting a price tag on drugs is a challenge – but by implementing two increasingly common pricing strategies, it is possible to satisfy both seller and buyer, claim ERT’s Stephen Raymond and Matthew Reaney.
 
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Marketplace & Business
Mergers and Acquisitions

Shared Vision


Dealing with employees is, arguably, the most important aspect of M&A. Mike Straw at Achieve Breakthrough reveals what company executives can do to ensure a smooth transition.
 
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M&A Activity Report

Across the Border


There is a noticeable shift towards acquiring in growing markets overseas, and investment in personalised medicine – EPC summaries these twin trends within M&A activity.
 
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Legal & Regulatory
Clinical Evaluation

Conform to the Norm: Part 1


In this first of a two-part article, Terry Winchell at GCP Innovative Dynamics offers an in-depth analysis of the FDA clinical investigator disqualification process, including early beginnings and how the FDA interprets its role.
 
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Electronic Solutions
Pharmacovigilance and Social Media

Keep Talking


Digital media is set to alter the way patients and companies communicate, observes Supriya Desai at Sciformix Corporation, but this change is not without risk.
 
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Review
Event Review

Latest on Life Sciences


EPC reports on the CMS Global Lifesciences Forum 2015, in which the biggest issues driving the sector were discussed.
 
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Manufacturing Environment
Medical Device Regulations

Step by Step

Chris Rule
at Maetrics advises medical device manufacturers to take great care in producing clinical evaluation reports, and proposes a 10-step plan to successfully comply with new regulations in 2018.
 
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News and Press Releases

Oxford Genetics licenses SnapFast™ expression vectors to Twist Bioscience

November 16, 2017, Oxford, England and San Francisco, US. – Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery, announced today a new licensing agreement with Twist Bioscience Corporation, a company enabling customers to succeed through its offering of rapid, high-quality synthetic DNA. Oxford Genetics will supply Twist Bioscience with its SnapFast™ technology platform to provide a broad range of application-specific expression vectors which Twist Bioscience will use to clone synthesized DNA for its diverse customer base.
More info >>

White Papers

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

United BioSource Corporation (UBC)

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
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Industry Events

5th Annual Peptides Congress 2018

16-17 April 2018, Novotel London West Hotel, Hammersmith, London

Oxford Global Conferences are proud to present our highly anticipated 5th Annual Peptides Congress, 16th– 17th April 2018, London, UK. Over 450 peptides, proteins and antibodies attendees representing global pharmaceutical organizations, leading biotech companies and internationally renowned academic institutions.
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