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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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PCI Pharma Services Announces Appointment of Angi Calkins as Chief Human Resources Officer
Philadelphia, PA – January 28, 2019. Leading biopharmaceutical services provider PCI Pharma Services (PCI) is pleased to announce the appointment of Angi Calkins as Senior Vice President and Chief Human Resources Officer. Angi joins PCI as the company experiences considerable growth and global expansion, currently with more than 3,500 associates, spanning eight locations comprised of 20 facilities across three continents. PCI features a broad portfolio of outsourced development and commercialization services focused in drug development and manufacturing, clinical trial supply, as well as commercial contract packaging.
More info >> |
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White Papers |
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Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >> |
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Industry Events |
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14th Annual Biomarkers Congress
21-22 February 2019, Manchester Central Convention Complex, UK
Oxford Global is proud to present for the 14th year our
flagship Biomarkers Congress, taking place 21 – 22 February
2019 in Manchester, UK. An updated programme ensures you will benefit
from talks on the latest strategies and technologies impacting growth in
the biomarker industry.
More info >> |
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