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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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Published quarterly in
February, May,
August and November

News and Press Releases

Dempsey Demystifies Regulatory Cycle at DIA Europe

March 22, 2018 (Hartford, Conn.) – RWS Life Sciences Managing Director, Sheena Dempsey, will present “Demystifying the Multilingual Complexities in the Regulatory Cycle” at DIA Europe 2018, on April 17, at 3:30PM (CET), in Basel, Switzerland.
More info >>

White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
More info >>

Industry Events

14th World Advanced Therapies & Regenerative Medicine Congress 2018

16-18 May 2018, Business Design Centre, London, United Kingdom

In May 2018 the World Advanced Therapies & Regenerative Medicine Congress, will bring together 800+ attendees and explore the rapidly developing world of ATMPs (Advanced Therapy Medicinal Products).
More info >>

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