Breaking News on Contract Research, Manufacturing & Clinical Trials

Regulatory affairs


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There are a number of ways Recipharm protects you. - Recipharm AB

02-Mar-2015 - Our serialisation process can help prevent reimbursement fraud, theft, the delivery of counterfeited medicines and more. Read our case study to learn how Recipharm can help protect every link in your pharmaceutical supply chain.
Download now!Technical / white paper

Meaningful Metrics – A CMO Perspective - Patheon Inc

05-Jan-2015 - Learn about the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage data, effective communications and ownership, and ways to improve your metrics. To optimize the value of metrics, it...
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Things are “heating up” in temp-controlled shipping - World Courier

24-Nov-2014 - The BRIC nations will account for $248 billion in pharmaceutical Sales by 2016. Global Pharma will spend $8 billion on cold chain logistics in 2014 These numbers demonstrate that as R&D goes, so goes logistics. As products evolve there is a...
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Customized drug application kits - B. Braun Melsungen AG

02-Oct-2014 - To avoid medication errors, application sets become more and more important for the pharmaceutical industry. These sets help to guarantee a safe and exact drug application.B. Braun OEM offers a flexible tailor-made solution to market your products in a ready-to-use...
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New Guidelines Strengthen Good Distribution Practice (GDP) -

18-Sep-2014 - The recently introduced EU Guidelines on the Good Distribution Practice of Medicinal Products for Human Use, (first published on March 8th 2013 as 2013/C 68/01 and updated on November 5th 2013 as 2013/C 343/01) places significant new demands on the...
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Turning “Oh No” into “No Problem” - World Courier

15-Sep-2014 - With all that’s going on in the world right now it’s vital for us all to have plans in place to deal with the unexpected. We need to be prepared individually, corporately and on a local and global level to...
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Viral-Challenge Studies: Regulatory Requirements - SGS

15-Sep-2014 - The use of viral-challenge studies as POC studies is gaining wider acceptance. This approach accelerates the selection of a safe and effective dose and dosing regimen for a new antiviral drug/ vaccine as it allows for early detec­tion of efficacy....
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7 Common Myths about QP Training Debunked : A Guide for Senior Managers - Reading Scientific Services Limited

11-Sep-2014 - The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one...
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Analysis of Biopharmaceuticals to Conform to ICHQ6B -

24-Jul-2014 - Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%.In 2010 the average...
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Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody -

19-Jun-2014 - Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental...
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Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection - ACM Global Central Laboratory

17-Jun-2014 - Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected and treated. The key risk factors of metabolic syndrome were identified approximately 250 years ago. However, there...
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Customs Warehouses Benefit Clinical Trial Supply Chain - Marken

11-Jun-2014 - Marken’s new customs-bonded warehouse within the Marken depot in Frankfurt, Germany allows Marken to store pharmaceuticals with an origin outside the European Union (EU) and distribute them to non-EU countries without undergoing the EU importation procedure for pharmaceuticals.
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Are there Any Markets left to Emerge? - World Courier

02-Jun-2014 - North America, Western Europe and—to a lesser extent—Australasia once served as prime locations for the majority of research. But these Western markets are approaching saturation, which has led to a lack of naive patients who are available and willing to...
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The Promise and Challenge of Adaptive Design: Oncology Trials - Medpace

05-May-2014 - Incorporating adaptive design methodologies into clinical trials can reduce costs while maintaining trial integrity.  Learn how these design strategies can improve the effectiveness and efficiency of oncology studies
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Shipping with Active Packaging Containers - World Courier

22-Apr-2014 - It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of...
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A year on, EU GDP’s affect on European Pharma Distribution - World Courier

24-Mar-2014 - World Courier welcomed the EU GDP guidelines, which created a yardstick by which logistics providers could be measured and compared.  A year on from the draft publication it is now fully in force and there has already been an update...
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Ensuring cold chain remains cold and controlled room temp remains controlled! - World Courier

24-Feb-2014 - The first of ten new vehicles have been delivered to World Courier Ground Europe, and in line with the requirements of the regulations for pharmaceutical distribution have undergone qualification testing for frozen, refrigerated and controlled room temperature conditions at extreme...
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20-Jan-2014 - Recipharm Stockholm has risen to the challenge of increased regulatory and customer-based inspections by devising an audit system that enables the company to be in a state of continuous inspection readiness. Recipharm, one of the busiest and most highly regarded...
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Clinical Document distribution - Secure and Automated - PharmaSOL

08-Jan-2014 - psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user specific escalation paths, with full receipt tracking. Recipients don't have to learn a new system, and your internal overhead is dramatically reduced.psiXchange...
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Applying a Health- and Science- based Risk Assessment for Multi-Product Biologics manufacturing - Fujifilm

18-Nov-2013 - Over the last 10-15 years, it has become common practice to manufacture biologics intended for clinical trials (Investigational Medicinal Products, or IMPs) in multi-purpose facilities.This flexibility has been a key enabler in ensuring a flow of novel products, frequently targeting...

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