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| home > epc > Winter 2002 |
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 PUBLICATIONS |
European Pharmaceutical Contractor |
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| At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in this issue of EPC |
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| In his Editor's Letter, Dr Graham Hughes reviews the articles in this Winter issue of EPC |
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| Until recently the idea of outsourcing pharmacovigilance activities fell outside the comfort zone of all but a few pharmaceutical companies. Liz Nowell, Pharmacovigilance Manager, Alan Rawling, Managing Director of Assured Information Systems and Dr Michael Bowden, Managing Director of the European Division, Health Decisions, discuss this new approach, in Meeting new Pharmacovigilance Challenges - the Need for Outsourcing |
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| In The Ethics of Research Related to Health Care in Developing Countries - Implications of the Report for the Pharmaceutical Industry, Professor Sir Kenneth Calman, Vice-Chancellor and Warden at the University of Durham, highlights the need to continue supporting future research as outlined in a report by the Nuffield Council on Bioethics |
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| John A Morris, Head of European Pharmaceuticals at KPMG, comments on recent developments threatening to wrest control of pricing further from the hands of pharmaceutical companies, in Pharma Companies Are Losing Control of Pricing |
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| Chris Tait, Head of Chubb Insurance, comments that careful risk management can minimise the potential for litigation, in Clinical Trials: Loss Prevention is Better Than Cure |
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| Parallel initiatives introduced in the US in the late 1990s have led to unprecedented growth in the field of paediatric clinical trials. Simon Robinson, Programme Director, International Paediatrics at Intercern, analyses this trend, in Paediatric Clinical Trials - Implications for Contractors |
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| Co-promotions often amply reward the participants and allow for collaborations that might not otherwise be consummated. In Prescription Drug Co-Promotion: 21st Century Dealmaking, David Schulman, David Wallis and Helen Hunsperger at International Law Firm Dechert, explore drug co-promotion activity |
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| In Managing Tax Payment - How to Avoid Paying Tax at 60 Per Cent or More, Andrew Hickman, European Regional Co-ordinator, and Emma Cuthbertson, Senior Manager in KPMG's London-based Global Transfer Pricing Services group, warn of the risk of double taxation and advise on how that risk can be managed |
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| Dr Graham Bunn, Global Vice-President of e-Clinical Business at Quintiles, investigates the complexity, regulation, process inertia and employee resistance to EDC scale-up, in The Great Escape - From EDC Pilot to Full Scale Implementation |
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| In In or Out? - IT Outsourcing Options for Pharmaceutical Companies, Nick Robinson, CEO of Phoenix IT Services, outlines the need to exploit all market opportunities and suggests that much can be gained from managed services, ASP and outsourcing relationships |
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| In The Outlook for Central Nervous System Drug Development, Dr Faiz Kermani, Budgets, Proposals and Marketing Executive, and Stuart McGuire, Business Development Executive at Chiltern International examine the progress in developing new treatments for these complex disorders |
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| Traditionally, sponsors have included feasibility checks in the process of choosing a study site. In Assessing Study Feasibility in the Netherlands - A Research Site's Point of View, Dr Henk Mulder, Director of Osteosupport BV, outlines a sponsor's key considerations for validation of a research site |
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| John Butterworth, Director of Clinical Trials Network at TNT Express, discusses the concept of providing a complete palette of logistics services to support clinical trials, in Improving Clinical Trial Logistics - A Courier's Perspective |
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| In Pharma Companies Must Jump on the Brand Wagon, Stephanie Loeffler, Partner at Marks & Clerk, considers the need for brand equity to be established and protected from the outset if it is to be profitable |
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| Richard Perkes, Technical Director at Cool Logistics, provides an overview of the direction in which the distribution industry is developing and outlines the options available for companies requiring improved performance from their temperature controlled packaging, in The Growing Importance of Cold Chain Distribution in the Pharmaceutical and Biotechnology Industries |
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| Biotechnology, especially its pharmaceutical sector, is regarded as one of the most promising areas of industry. In Biotechnology - A Challenge for Young Companies and Old Regulators, Pekka Kurki, MD, PhD, Senior Medical Officer at the Department of Pharmacology, National Agency for Medicines, Finland, analyses the challenges posed for industry |
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| In EDC Use in Clinical Trials: Are we on the Verge of a Breakthrough?, Mike Miller-Smith, Marketing Manager at CRF Box, raises important issues vital to the successful widespread adoption of electronic data capture (EDC) based on experiences gained both from a pharmaceutical company and vendor perspective |
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| Rainer Hilli, Partner and Tom Groop, Associate of Roschier Holmberg Attorneys Ltd, examine the Finnish Government's suggested procedure for generic substitution, in Generic Substitution - The Proposed Procedure for the Prescription of Pharmaceuticals in Finland |
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| For many years now, there has been centralisation of laboratory analysis for particular aspects of clinical trials. In Rationalised Analytical Laboratory Services for Tomorrow's Clinical Trials, John L Allinson, Laboratory Director of BAS Analytics in the UK, examines the potential for the bioanalytical and central laboratory to form a much closer working relationship |
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| Pharmaceutical and biotechnology companies have one thing in common: they rely on high quality laboratory results in order to evaluate the efficacy of their drugs. Dr Hermann Schulz, President and Co-Founder of INTERLAB GmbH, discusses this need, in Centralised Laboratory Testing for Clinical Trials: The Advantages of Using a Global Specialist |
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| Rome, 'The Eternal City', will host the 15th Annual DIA EuroMeeting in March 2003. In a preview, The Drug Information Association outlines the agenda and programme news for the event to be held this coming spring |
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| InfoTechPharma is the unique world meeting place for information technology specialists and R&D professionals working in the pharmaceutical and biotechnology industries. In InfoTechPharma 2003, The 7th Annual Conference and Free Exhibition, event organisers IBC Life Sciences inform us of what's in store |
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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PFIZER PRESENTS OVERALL SURVIVAL DATA FOR SUTENT™ VERSUS INTERFERON-ALFA
Chicago, 31 May 2008- Results from a landmark study have shown that sunitinib (SUTENT™)
has demonstrated overall survival greater than two years in patients with
metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer.
This is the first time overall survival data representing more than two years
has been achieved in the first line setting of mRCC, which is clinically
meaningful and reflective of major advances in the treatment of kidney
cancer.
More info >> |
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