Implementation of the Hong Kong Electronic Health Record Sharing System

The Electronic Health Record Sharing System Ordinance came into effect on 2 December 2015. The Ordinance provides the legal framework for public and private hospitals and other healthcare providers to collect, share and keep patient’s electronic health record (eHR) through the Electronic Health Record Sharing System (the eHRS System) upon obtaining the informed consent of […]

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Canada – Threading the Biosimilar Needle

Biosimilars, otherwise known as subsequent entry biologics or “SEBs” in Canada, are a rapidly emerging trend in healthcare. There is a common misconception that biosimilars are “generic” biologic medications. In reality, biosimilars and traditional generic pharmaceuticals are significantly different, principally due to the distinct nature and complexity of the molecular structure of biologics. Biosimilars present […]

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Drug Makers to Prepare for Pharmacovigilance Reforms in Russia and Other EAEU Countries

Drug companies operating in Russia and other Eurasian Economic Union (“EAEU”) countries are being advised to prepare for the new obligations and liabilities that an impending new regulation on pharmacovigilance in the EAEU might introduce for them. The new regulation, which will bring the EAEU more in line with the EU rules on pharmacovigilance, is currently […]

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Equal sign or human rights campaign symbol on a white computer key isolated on white. Key'€™s clipping path included. The red color of the equal sign can be easily modified in photoshop by moving the Hue/Saturation slider without affecting the rest of the image.

This is a part of a large computer key type collection including letters, numbers, various symbols, emoticons etc.

Italy: Drugs, Competition, Bioequivalence and Therapeutic Equivalence

The Italian Supreme Administrative Court has just released an articulated judgment (n. 1306 of April 1, 2016) focused on the notion of “therapeutic equivalence” of pharmaceutical products, a concept which, as specified by the administrative judge, is conceptually and legally distinct from that of “equivalent drug” and “biosimilar drug”. ”The origin of the notion of […]

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EMA Begins EudraVigilance Training Courses

The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA). Two sets training courses are available. The first set of three-day training courses is targeted […]

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Launch of New European Stem Cell Bank

23 March 2016: Launch of the European iPSC Bank EBiSC, the European Bank for induced pluripotent Stem Cells announces the public launch of its on-line catalogue of induced Pluripotent Stem Cells (iPSCs) which are available to academic and commercial scientists for use in disease modelling and other forms of pre-clinical research. (https://cells.ebisc.org). The initial collection […]

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Kick-off meeting of the third HTA Joint Action

Kick-off meeting of the third HTA Joint Action: 3 March 2016 The kick-off meeting of “EUNetHTA 3” (2016-2019) – the third Joint Action which aims to pave the way for sustainable cooperation on Health Technology Assessment (HTA) in Europe takes place in Amsterdam today. Building on achievements of the previous two, the specific objective of […]

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Mytrus Technology Chosen for ADAPTABLE Aspirin Pragmatic Trial

Davis, CA. – March 07, 2016 – Mytrus, a pioneer in innovative technologies for improving patients’ participation in clinical trials, has announced that its Enroll® and Engage™ technology infrastructure will support the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness) trial being conducted by the Duke Clinical Research Institute (DCRI) as the […]

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Draft Guidance on Format of the Risk Management Plan (RMP) in the EU

Summary The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices (GVP) module V in the view of getting a focussed risk management system and simplifying the […]

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