Clinical Trials Briefing - Marie Manley Ebook

Download Ebook: Navigating the Perils of the Clinical Trials Regulation

On 16th April 2014 the new EU Clinical Trials Regulation was adopted. This new regulation, which comes into force in 2016, replaces a convoluted Clinical Trials Directive and aims to streamline clinical trial applications across the EU, making cross border trials easier. Marie Manley is Head of the Regulatory team at Bristows and has an in depth understanding of the new …

Download Ebook: Mylan on EU Clinical Trials Regulation

On 16th April 2014 the new EU Clinical Trials Regulation was adopted. This new regulation, which comes into force in 2016, replaces a convoluted Clinical Trials Directive and aims to streamline clinical trial applications across the EU, making cross border trials easier. Manfred Kurz, Senior Global Regulatory Affairs Manager at Mylan has an in depth knowledge of how clinical trials are conducted …

Clinical Trial Management System Market, Trends and Forecasts

A new report has stated that the global Clinical Trial Management System (CTMS) market “is expected to grow at a CAGR (compound annual growth rate) of 14% from 2014 to 2019, to reach an estimated value of USD 1,848.5 million in 2019”, compared with USD 844.0 million in 2013. CTMS is a software system which manages clinical trials in clinical …

Delay for Clinical Trial Data Publication Policy Adoption

The EU Clinical Trials Regulation has been drafted over and over again and now it would appear that another facet of it will be rethought. Proposals which would have allowed secondary researchers to download, save and print clinical trial data will now not be formally adopted until October. This is because the European Medicines Agency (EMA) would like to clarify …

Closer ties for EU & Australia in Orphan Drugs

The European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) have announced, at a collaboration meeting in London, that they are to share the full assessment reports related to marketing authorisations (MA) for orphan drugs. According to EMA executive director Professor Guido Rasi and Professor John Skerritt, national manager of the TGA, this will lead to greater scientific exchange when …

Guest Post: Rapid Effectiveness Assessment Process Could Shape HTA in Eastern Europe

This article was provided by Richard Staines of APM Health Europe from its coverage of the recent Health Technology Assessment World conference in London. A rapid European effectiveness assessment process comparing new drugs to standard of care could provide key data for local health technology assessment (HTA) in smaller European countries, experts have been told. However, Wim Goettsch, project leader …

Study reveals EU’s most favourable biosimilar market

A study of five European Union nations has revealed which one provides the most favourable environment for biosimilar drugs. The study, which was led by Professor Henry Grabowski, director of programme in pharmaceutical health economics at Duke University in North Carolina, assessed the market experiences of biosimilars in five EU nations – France, Germany, Italy, Sweden and the United Kingdom. …

Infographic: Orphan drugs in the EU

This is an infographic for medicinal products with orphan drug designation and marketing authorisation in the EU.   ORPHAN DRUGS in the EU | Create infographics What do you think? You might be interested in attending the World Orphan Drugs Congress Asia 2013 held on the 18-19 June 2013 at Grand Copthorne Waterfront Hotel, Singapore to learn more about orphan …

Number of patients studied before EU drug approval “insufficient”

The number of patients studied before regulatory drug approval in the European Union (EU) is insufficient, according to research published in PLoS. Before any new drug can receive marketing approval for use in humans, it must undergo extensive laboratory and clinical testing to determine its safety and efficacy. The researchers detailed that, to fully evaluate safety and efficacy of medicines …