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.

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.

Listen to this podcast to hear Anne Blanchard, Founder of Blanchard & Associates in Buenos Aires, Argentina, and author of the Latin America section of the GCP Question & Answer Reference Guide 2012 chapter, “Clinical Trial and GCP Standards in Selected Leading Regions,” discuss best practices in GCP in leading Latin American countries. Covering topics such as the regulatory framework and process, informed consent, GCP monitoring by regulatory authorities, all with country-specific information.

Download this podcast to hear about all new updates to the current Good Clinical Practice Question & Answer Reference Guide, May 2012. Answering hundreds of questions about GCP, the book is the must-have resource for CRAs, investigators/sites, auditors, compliance, legal, and other clinical research professionals. In this podcast, the editor of the book, Michael Hamrell, discusses what’s new in 2012, such as the FDA’s guidance related to risk-based monitoring approach to clinical trials, and the latest data and trends on the FDA and EMA’s clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance.