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| home > epc > Autumn 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 Autumn issue of EPC |
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Regulators may be placed in a difficult position regarding the approval of new drugs where the majority of the dossier comprises of foreign clinical data. Carly Anderson and Faiz Kermani of CMR International debate this issue, in Global Acceptability of Clinical Data - Fact or Fiction?
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| In Mergers - Not the Only Way to Grow, John Morris, Head of KPMG's European Pharmaceutical Practice, discusses a likely slowdown in major merger and acquisition activity in the near future and suggests that companies look to other opportunities in order to grow |
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| Ben Coppin, Chief Operating Officer of Envisional Limited, outlines the recent increase in the illegal sale of prescription drugs online, in A Call to Regulate the Online Sale of Prescription Drugs |
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| Geoff Parker, Director of Scimcon, highlights the causes of the lab information mountain and offers tips on how to conquer it, in Information Overload |
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| In In Search of the Organisation?, Dr Flic Gabbay, Director of Strategic Projects at Micron Research, considers the redefinition of corporate culture in outsourced networks |
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| Wireless technology offers a safe and effective method of revolutionising the industry by helping to speed up the trial process. Richard Hanscott, Vice-President of Business Solutions at Orange UK, reflects on recent advances, in The Future of Wireless Technologies in Clinical Drug Trials |
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| Dr Milen Vrabevski, Medical Director at Comac Medical, continues his investigation of the advantages and potential pitfalls for multinational pharmaceuticals operating in emerging scientific markets, in part two of Clinical Trials in Bulgaria |
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| In Increasing Trial Performance Through Replicated System Technology, Eli Hauser, Executive Director Strategic Programs at Phase Forward Incorporated, looks at how EDC systems for trial data collection and management have heightened demand for access to the clinical trial database and increased our sensitivity to site connectivity and usability concerns |
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| Philip Guard, Vice-President of European Operations at Clinimetrics Research Associates Inc, explores Moving Through Clinical Phases II and III and considers the implications of decision-making and communication at each stage |
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| Regulatory genetic toxicology testing produces between 20 and 25 per cent in vitro positive results year on year. Jon Kitching from the Department of Experimental Biology at Huntingdon Life Sciences, examines the Comparison of the Regulatory Ames Test with the SOS/umu Assay as Part of Lead Optimisation Screening |
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| In CRO Selection - A Process Revisited, Sherif Odaranile, Clinical Auditor at ADAMAS Consulting, suggests how best to structure a sponsor's outsourcing teams to maximise returns on investment |
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| Aggressive tax regulations have already forced multinational pharmaceutical companies to consider the tax implications of their transfer pricing arrangements. However, Dr Edward Keen, Senior Director, Transfer Pricing at KPMG UK considers the non-tax implications, in The Importance of Transfer Pricing to Pharmaceutical Contracting Companies |
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| Ruth Paul, Regulatory Manager at Simbec Research Ltd, discusses The Role of the EU National Agencies in European Regulatory Affairs and comments that despite harmonised EU regulatory procedures, the working methods of the individual agencies in member states still have a long way to go |
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| In Drug Interactions: Implications for Pharmacogenetics in Drug Development, Dr Rashmi Shah, Senior Medical Officer at the Medicines Control Agency, highlights the perils of drug-drug interactions that afflict many drugs during routine clinical use |
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| The timing of the development of lipodystrophy will have an impact on the potential market sales of a therapeutic drug. Dheeraj Khiytani, HIV Analyst at Datamonitor, explores the implications, in Fat Redistribution in HIV Patients - An Opportunity for Drug Manufacturers? |
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| In Novel Use of Interactive Voice Response Systems in the Measurement of Clinical Endpoint Data in CNS Studies, Dr Bill Byrom at ClinPhone Group Ltd, and Dr John Greist of Healthcare Technology Systems, explore the more novel uses of IVR when measuring clinical endpoint data and the extension of this methodology as a pre-screening patient qualification tool |
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| Dr Thomas Bart, Managing Director of e-Clinical Research GmbH, provides a short overview of the current practice and possible future developments in clinical research electronic data capture, in EDC: Quo Vadis? |
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| EDC tools would seem to be the perfect antidote for problems posed within the clinical trials industry. In Making EDC Work for You, Kate Foster, Associate Director, Global Client Services for CB Technologies, presents the pros and cons of incorporating EDC |
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| In Integrating Document Management and Content Management Systems in the Pharmaceutical Industry, David Gingell, Marketing Director, EMEA at Documentum Inc, highlights a market under pressure and explains that content management can contribute significantly to easing some of the tension surrounding speeding time to market |
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| Mike Nell, Technical Director and Mark Wren, eService Director at Phase Forward Incorporated, offer some advice on honing your competitive edge, in How to Get Ahead in Electronic Data Capture |
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| If the dream of proteomics is the identification and characterisation of all proteins, then the nightmare is the number of unique functional protein structures. Dr Lucio van Rooijen, Vice President Business Development, and Dr Josef Schwarz, Director of Protein Profiling at Xzillion, examine the Ongoing Challenges in Proteomics |
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| The LIMS arena has experienced some headline changes recently and a keen awareness of the implications of these could prove invaluable in assessing both the system and the vendor. John Dickson, Consultant at Thermo LabSystems outlines a vendor's perspective, in What's New in LIMS? |
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| Thomas Allen, Director of Allen Preclinical Consultants GmbH discusses bridging the gap between the pharmaceutical and preclinical CRO industries, in Perspectives in Preclinical Development |
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| Regulatory changes in the transportation of infectious substances profoundly impact many health care sectors. David Cocker of MDCPartners considers the impact of these changes, in A Different Strategy in a Changing World of Infectious Substances |
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| Julia Lloyd-Parks, Senior Consultant at Technomark Consulting Services Ltd, reviews the 38th Annual Meeting of The Drug Information Association, Chicago, which took place in June |
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News and Press Releases |
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PHARM Connect 2019
Life science and business are going to meet at PHARM Connect on the
12-13 of March 2019 in Budapest, Hungary to continue the tradition of
providing high calibre, customised professional partnering opportunities
for pharma and biotech professionals from Central & Eastern
European and beyond and deliver the crucial information they need to
excel in their work. The influential annual gathering brings together
over 400 global and regional decision-makers, top scientists, industry
executives and business development leaders for the ninth time to
identify new business opportunities, technologies, state-of-the-art
formulation development strategies and to foster exchange of ideas on
the role of the sector.
More info >> |
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White Papers |
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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 >> |
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Industry Events |
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10th Annual Summit for Clinical Ops Executives
18-21 February 2019, Hyatt Regency Orlando, Florida
Celebrating its 10th successful year, SCOPE Summit 2019 takes place
February 18-21 in Orlando, FL. Over the course of four stimulating days of
in-depth discussions in 19 different conferences, 3 plenary keynote sessions,
and the ever-popular interactive breakout discussions, the programming focuses
on advances and innovative solutions in all aspects of clinical trial planning,
management and operations, including...
More info >> |
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