TAKE Solutions Announces "eCTD Validation: How Do I Know It Will Be Accepted At The Agency?" Webcast.Community Interest Webcast Will Be Conducted by Harv Martens of The ICH See Intel Hub Architecture. M2 Standards Committee & ING America RALEIGH, N.C. -- Today, TAKE Solutions announced the second in its 2007 webcast series, "eCTD Validation See validate. validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. : How do I know it will be accepted at the agency?". This webcast will be conducted by Mr. Harv Martens on March 6th for US and Canadian Canadian (kənā`dēən), river, 906 mi (1,458 km) long, rising in NE New Mexico. and flowing E across N Texas and central Oklahoma into the Arkansas River in E Oklahoma. audiences, and March 8th for European audiences. "Submitting fully compliant eCTD submissions requires an understanding of multiple specifications, guidance documents and the agency's 'current thinking'. This webcast will cover common misunderstandings, concerns from regulators and you, as well as the five key questions to ask your eCTD tool vendor," stated Harv Martens. Harv Martens, president of ING America, has served for over ten years on the ICH M2 Expert Working Group. In this capacity, he co-authored the ICH eCTD specification, as well as the ICH standard for safety reporting known as ICSR ICSR International Conference on Software Reuse ICSR International Conference on Shellfish Restoration ICSR Individual Case Safety Report ICSR International Center for Standards Research (University of Colorado) . He is currently leading an ICH M2 project to study interoperability The capability of two or more hardware devices or two or more software routines to work harmoniously together. For example, in an Ethernet network, display adapters, hubs, switches and routers from different vendors must conform to the Ethernet standard and interoperate with each other. and compliance (with ICH and regional guidance and specifications) of the eCTD tools on the market (www.etics.us). "We are absolutely committed to delivering domain value to the regulated life sciences marketplace. The industry feedback we've received confirms that educational topics such as eCTD validation speak to everyone's concerns right now. Our 2007 webcast series has been developed in conjunction with industry subject matter experts to help the industry better understand submissions guidance, avoid common agency pitfalls, and accelerate product time-to-market," stated Robert MacDougall, Executive Vice President Sales & Marketing, TAKE Solutions, Inc. For more information on the webcast -- "eCTD Validation: How do I know it will be accepted at the agency?", email Nicole.Contardo@TAKESolutions.com . TAKE Solutions is a technology-enabled Business Solutions company with recognized industry leadership in Microsoft-based Solutions, Regulated Life Sciences, and Supply Chain Management. With employee strength of over 500, TAKE Solutions has U.S. offices in Princeton, NJ, Research Triangle Park Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , NC, and Philadelphia, PA. TAKE Solutions conducts business today across the globe with more than 150 FORTUNE 1000 customers. TAKE Solutions is SEI-CMMI Level 5 Certified See certification. , Microsoft Gold Certified, a member of the Microsoft Global BioIT Alliance and is a Registered CDISC CDISC Clinical Data Interchange Standards Consortium Solution provider. For more information about TAKE Solutions visit www.TAKESolutions.com. |
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