Elsevier’s PharmaPendium™ Adds European Medicines Agency (EMEA) Documents
Site becomes the only source of consolidated, searchable access to both FDA and EMEA drug approval documents
New York, NY – October 14, 2008 – PharmaPendium, Elsevier’s online resource for authoritative drug safety data, has significantly expanded its content offering with a new release containing the European Medicines Agency’s (EMEA) European Public Assessment Reports (EPARs). The addition of this content makes PharmaPendium the only source of consolidated, searchable access to US Food and Drug Administration (FDA) and EMEA drug approval documents on a single site, with a single search.
EMEA is the European agency for the evaluation of medicinal products. This new content offers critical insights into the EMEA regulatory point of view, their reasoning underlying drug approval and the qualifications put on that approval.
“The Pharmaceutical industry is facing increasing pressure to identify drug candidates with the best possible safety, delivery and efficacy profiles as early as possible and PharmaPendium is uniquely positioned to address these challenges,” commented Philip MacLaughlin, Senior Product Manager at Elsevier.
The EMEA’s EPAR documents cover medicines assessed by the Committee for Medicinal Products for Human Use (CHMP). EPAR documents include efficacy, indication, safety and pharmacokinetics data and mode of action information. The EMEA database on PharmaPendium makes readily accessible approximately 80,000 pages of searchable documents for more than 300 active ingredients approved for the European market – some not approved in the US. It also presents preclinical and clinical toxicity and adverse effects data manually extracted from these documents. General product information documents are also included.
“Providing our users with the European Medicines Agency documents adds another important dimension to our coverage,” said MacLaughlin. “This information will benefit companies operating globally because it provides critical access to another major regulatory body’s points of view, precedents and data, including drugs approved only in Europe, and the availability of this information, combined with the FDA documents and other PharmaPendium data sources, will lead to a deeper understanding of the full scope of projected risks early in the drug development process and consequently reduce drug development costs and avoid regulatory cycling.”
The EMEA Documents database is included as part of PharmaPendium licensing agreements at no additional fee and the content is automatically available to all users. More information about the European Medicines Agency and EMEA approval documents can be found at www.info.pharmapendium.com/emea.
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PharmaPendium, The Essential Resource for Preclinical Safety and Risk Assessment, is a unique online resource that provides access via a single point to searchable and trusted drug information. It covers over 3100 approved drugs, with integrated preclinical, clinical and post-marketing safety data.
PharmaPendium is designed to meet the needs of preclinical safety assessment teams, toxicologists, pharmacokineticists, safety pharmacologists, regulatory affairs staff, pharmacoepidemiologists, clinical researchers and information specialists. It enables text-search of FDA Approval Packages and European Medicines Agency (EMEA) European Public Assessment Reports (EPAR) Approval Documents as well as other data sources. Adverse events and toxicity data are carefully extracted from preclinical and clinical studies from all of these sources. Elsevier offers a broad spectrum of solutions to make processes in drug discovery, preclinical and clinical drug development more efficient, e.g. CrossFire and Reaxys, EMBASE and PharmaPendium. More information can be found at www.elsevierforindustry.com.
Elsevier is a world-leading provider of information solutions that enhance the performance of science, health, and technology professionals, empowering them to make better decisions, deliver better care, and sometimes make groundbreaking discoveries that advance the boundaries of knowledge and human progress. Elsevier provides web-based, digital solutions — among them ScienceDirect, Scopus, Research Intelligence and ClinicalKey— and publishes over 2,500 journals, including The Lancet and Cell, and more than 35,000 book titles, including a number of iconic reference works. Elsevier is part of RELX Group, a world-leading provider of information and analytics for professional and business customers across industries. www.elsevier.com
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