This training on GCP regulations will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.

Course Description: This interactive two day seminar will cover the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway. his two day interactive course on European Clinical Trial Directive will cover: -Requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive (for Drugs, Biologics & Combination Products); -Recent updates on EU-GCP associated with the Directive; -Highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators; -Changes to the Clinical Trial Directive that are being contemplated and may receive modification.

Our 2013 summit will build on last year’s successful event. With double the number of tracks this year, the Immunogenicity Summit 2013 presents technologies for safety and efficacy from bench to bedside. For early stage decision making on drug design and optimization, we examine the causes of immunogenicity together with means of mitigation, and present PK/PD and bioassay strategies. For later pre-clinical and clinical stages, we examine the complexities of immunogenicity assays, bioassays and PK/PD development, and present risk assessment strategies for smooth interaction with the regulatory authorities, and safe and efficacious products in the clinic.

Wingspan announces that Actelion Pharmaceuticals, a top 20 biopharmaceutical company, has selected Wingspan eTMF as its official electronic trial master file. The company, based in Switzerland, outlined specific goals of the trial master file implementation including providing key management metrics, increasing inspection readiness, saving time, reducing costs and increasing eTMF quality.

Allscripts has entered into an agreement with the newly-established Montefiore New Rochelle and Montefiore Mount Vernon to expand the relationship at those locations, which were recently acquired by Montefiore Health System. This partnership will upgrade both hospitals to Allscripts Sunrise™ 6.1 Integrated Electronic Health Record as well as the Sunrise Clinical Analytics™, Sunrise Radiology™ and Sunrise Laboratory™.

Sysmex America Inc., a global leader in medical diagnostic testing equipment and information systems technology, today announces a partnership agreement with Software Testing Solutions (STS) of Tucson, Arizona, to provide automated testing services for Sysmex WAM™ Decision Support Software for the Clinical Laboratory.

Accelrys, Inc. (NASDAQ: ACCL), a leading provider of scientific innovation lifecycle management solutions, has announced the latest release of its unified biology assay and study management software suite consisting of Accelrys BioRails DM 4.5, Accelrys BioRails PTO 4.5 and Accelrys Morphit 3.0.

In this CAPA training webinar, we will focus on ideas that will help identify effective methods designed to improve your response to process deviations and help you develop a standardized plan to fully resolve discrepancies so they do not recur.

Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.

GSL Biotech announced today that Transcriptic, a Silicon Valley company, has adopted SnapGene both for its in-house team of scientists and for use by its customers. Transcriptic is now providing customers with short-term access to SnapGene for use during the ordering process.

RURO Inc. is pleased to announce the release of FreezerPro version 6.1, the latest refinement to the award-winning frozen sample management solution. FreezerPro, a world-class software solution used by thousands, improves its capability to manage and track frozen samples in FreezerPro 6.1.0. FreezerPro is a fast, reliable, and secure network-based platform that provides an appealing user interface with access to a plethora of tools. The program enables users to know precise sample location even before opening the freezer door, and supports more efficient frozen sample storage and management procedures.

The Society for Laboratory Automation and Screening (SLAS) is decentralizing its volunteer leadership structure to achieve the international initiatives outlined in the newly updated SLAS Strategic Plan. The newly refreshed plan was developed for 2014, 2015 and 2016 by the SLAS Strategic Planning Advisory Committee. After being officially approved and accepted by the SLAS Board of Directors, the plan was published at http://www.slas.org/about/plan.cfm when the Society unveiled its attractively redesigned, user-friendly website on November 1.

Agilent Technologies Inc. (NYSE: A) today introduced the 850-DS Dissolution Sampling Station for centralizing laboratory workflow of sample transfer, filtration and collection. By managing unattended dissolution sampling and automated sample archiving for future HPLC or UV analysis, the 850-DS frees up analysts' time while eliminating errors associated with manual sampling.

AACC is pleased to announce that the AACC Annual Meeting & Clinical Lab Expo won the 2013 Trade Show News Network (TSNN) award for having the fastest growing attendance of all nonprofit trade shows. The AACC Annual Meeting is also known for being the world's largest diagnostics conference and expo.