Download this podcast with Dr. Jules Mitchel, President of Target Health Inc., to hear about the challenges associated with source data/documentation and eSource. Dr. Mitchel is the key contributor to this year's GCP Q&A Guide's Chapter on "Source Data and Documentation." Hear his perspectives and predictions related to certified copies, electronic health records, and the challenges and opportunities for industry.

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This exclusive podcast is with Sandra SAM Sather, MS, BSN, CCRA, CCRC, Founder of Clinical Pathways, LLC. SAM is the author of the GCP Question & Answer Reference Guide's section on "The HIPAA Privacy Rule and FDA-Regulated Clinical Trials." Hear SAM discuss the latest changes, areas of confusion, and strategies for sites, sponsors, CROs, and IRBs.

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Listen to this exclusive podcast with Teri Stokes, Ph.D., Director & Founder, Global Validation Consultant, GXP International, the key contributor to the GCP Q&A Guide's Section 11, "Computerized Systems, e-Clinical Trials, and Electronic Records Rules." Dr. Stokes discusses the challenges and concerns related to computerized systems, as well as their impact on site and sponsor personnel.

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Download this podcast to hear more about Barnett's new title: IND Submissions: A Primer. Hear the author discuss the book's "hands-on" approach that will teach Regulatory professionals -- novice and veteran alike -- to work with regulations, guidance documents, content templates, style guides, the necessary information needed to write the document and provide writing tips to produce a range of U.S. drug and biologics submissions that comply with the requirements and are clear to read.

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Download this podcast to hear more about Medical Device Development: Regulation and Law, the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The new edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today.

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