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Under Control

A controlled substance is a drug or chemical whose manufacture, possession or distribution is highly regulated by the government and subject to legislative control. They include illegal drugs, prescription medications and chemicals considered as precursors to the production of illegal drugs. These are all believed to cause harm to an individual if not used properly. Their manufacture and distribution are closely monitored by the United Nations (UN).

The construction of an international legal framework for controlled drugs has gone through several stages of development since the 1920 alcohol prohibition in the US. In 1961, the Single Convention on Narcotic Drugs was established as a universal system to limit the cultivation, production, distribution, trade, use and possession of narcotic substances strictly for medical and scientific purposes, with special attention to those produced from plants.

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Rich Nelson is the Distribution Services Manager for PCI’s Clinical Services group, working with clients to provide seamless global distribution of their investigational products. He joined the company in 2012 after seven years with Fisher Clinical Services, having supported both global distribution for investigational products, as well as interactive voice response solutions. Rich is certified in Lean Six Sigma/continuous improvement, including as a Small Group Facilitor/ Corporate Trainer, and is a graduate of Monmouth University, US.
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Rich Nelson
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Conveying Medical Guidance in Clinical Trials – A Survey

Europital Medical Consultancy

With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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Temperature Controlled Logistics 2018

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Each January for the past 16 years, more than 400 senior supply chain, logistics, storage, regulation and quality experts from the pharmaceutical industry have gathered at the TCL Forum for the largest, longest running and most comprehensive cold chain and ambient logistics conference in Europe.
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