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| home > epc > Autumn 2004 |
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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 her Editor's Letter, Julia Lloyd-Parks reviews the articles in this issue |
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| Joseph L Herring, President and Chief Operating Officer at Covance Inc, makes a battlecry for CROs to "collaborate or stagnate", in A Winning Prescription for Drug Development Outsourcing |
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| Recent years have seen the European pharmaceutical and biotechnology industries caught up in a quagmire of re-organisation and increased M&A activity. Nick Stephens, Managing Director at RSA Consulting Ltd and Robert Bates, Managing Director of RSA GmbH, consider the possibilities of Expanding Overseas - What are the Challenges? |
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| In Choosing the Right Translation Services Provider: The Key Facts, Octavia GuzmСn, Head of Scientific Translations at Translator Legal and Financial SL, examines the impact for pharma of nine new official languages in the newly-expanded EU |
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| The 'off label' use of medications in paediatric studies is becoming increasingly widespread. Dr Robert M Nelson, MD, Associate Professor of Anaesthesia and Pediatrics, Department of Anaesthesiology and Critical Care Medicine at The Children's Hospital of Philadelphia, and the University of Pennsylvania, looks at ways of Stimulating Paediatric Drug Research: Comparing the US and EU Approaches - Part I |
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| Lewis Weidman, Director of Vitalograph Ltd, describes the background to COPD and asthma studies, examines areas where data quality can be compromised, and suggests how this can be improved today, in Maximising Data Quality in Respiratory Clinical Trials |
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| In Clinical Trials in Central and Eastern Europe, Giancarlo Carmosino, Clinical Trials and Health Care Technology Development Director of CROM srl and Wanda Malkowska, General Manager of CROM Polska, review the stats suggesting that CEE is a region capable of providing a significant contribution to the development of new drugs for the international market |
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| Professor Georg Dorffner, Chief Executive Officer of The Siesta Group Schlafanalyse GmbH, investigates current trends in sleep medicines research, in Revolutionising Sleep Studies: Making the Most of Multi-Centre Clinical Trials |
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| With the accession of 10 countries into the EU, projections of significant parallel trade between old and new member states have been made. In EU Enlargement, Patents and Pharmaceuticals, Christoph T Feddersen, Associate at Cleary, Gottlieb, Steen & Hamilton, Brussels, analyses the Community's new Specific Mechanism provision |
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| In The EU Clinical Trials Directive and the New Europe, Keren Winmill, Director of Pharmaceutical Services at Penn Pharmaceutical Services, ponders whether the addition of 10 member states will improve the climate for research and if implementation of the EU Clinical Trials Directive in Europe will help or hinder that crucial process? |
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| Will India Become the Outsourcing Capital for the Global Pharmaceutical Industry? Dr Nermeen Varawalla, Vice President, Business Development International at PRA International, considers the possibilities |
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| Paul Hunt, Managing Director and CEO of Pharm-Olam International (UK) Ltd, weighs up the pros and cons when Searching Broader Horizons - Opportunities for Clinical Trials in India |
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| In Developments in Electronic Data Capture in the Pharmaceutical Sector: Where Data has Full Dominion, Gary Hawksworth, Head of Marketing for Pharmaceuticals at BT, introduces us to the dynamic field of telecare |
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| In today's active climate, who can afford not to employ methods that allow comprehensive surveys of the vast scientific literature freely available for review? James Fickett, Director, Strategic Capabilities, Discovery IS and Informatics, and William Hayes, PhD, Global Cross-Discovery and External Technology Strategic Capability Manager for AstraZeneca, put the spotlight on Text Mining for Drug Discovery |
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| Over the last 10 years, laboratory information management systems have changed beyond recognition. Stefano Marocco, Account Manager and Elian Winstanley, Office Manager at STARLIMS, UK, give us their perspective of the latest Developments and Trends in LIMS - A 'Coming of Age'? |
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| Steve Westcott, Managing Director at Melbourn Scientific, reviews the methods needed to be transferable from different research laboratories in order to face the rigours of external validation and the realities of the production line, and asks How Well Do You Know Your Method? |
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| Graham Buckton, Chief Executive Officer of Pharmaterials Ltd, gives us the low-down on the Physical Characterisation of Powders, explaining why it has become so important and what advances have occurred |
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| In Understanding the Challenges and Opportunities in Nasal Drug Delivery, Dino J Farina, Founder and President of ImageTherm, tackles the key issues of development, formulation, testing and regulation |
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| In Conducting Oncology Clinical Studies: Perils, Pitfalls and Practical Tips, patient recruitment difficulties, long timelines, complex study designs and the increasing use of sites around the world are all factors under the microscope of Mark Grose, Vice President, Program Management, at Endpoint Research |
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| Global interest in cancer research continues to concentrate minds from across the pharma industry - the 2004 meeting of the American Society of Clinical Oncology was attended by 25,000 people from 119 countries. Professor Gordon McVie, Oncology Advisor at Inveresk, presents Anticancer Drug Development - A Global View |
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| In The 'Life' of a Clinical Trial Sample, Helen Springford, Director of Business Development at IMFORM, and Sue Lee, Manager of BioPharm Systems, Research and Development at World Courier, offer us a fascinating insight into the highs and lows experienced by an HIV blood sample from collection to delivery |
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| Stephen Errey, Managing Director at Lucidea Consulting Limited, looks beyond the common perception that logistics is simply a cost to be controlled or a process to be improved to pose the question Logistics - What's In It For You? |
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News and Press Releases |
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Clinical and Regulatory Operational Excellence Forum
1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment?
Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers |
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Clinical Research in Spain
BioClever
This whitepaper is on clinical research in Spain, giving a general outline of the main characteristics of research in this country and an overview of the applicable regulations, along with the reasons why Spain is a good place to do research.
More info >> |
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Industry Events |
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