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BARNETT NEWS

Barnett International Announces New SOP Development and Optimization Courses
February 21, 2012
Barnett International Announces New Fall-Winter Courses 2012
February 20, 2012
Barnett Educational Services Announces Buy One, Get One Free DVD Holiday Sale!
December 15, 2011
Hamrell Appointed Editor of Barnett International’s Good Clinical Practice: A Question & Answer Guide
November 16, 2011
Barnett International Announces New Fall-Winter Courses
September 29, 2011
Barnett Educational Services Announces Buy One, Get One Free DVD Sale!
June 6, 2011

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Clinical Trial and GCP Standards in Selected Leading Regions
Exclusive Interview with Anne Blanchard 

 

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.

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Source Data and Documentation
Exclusive Interview with Dr. Jules Mitchel  

 

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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IND Submissions: A Primer
Exclusive Podcast with Meredith Brown-Tuttle, RAC, author 

 

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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Medical Device Development: Regulation and Law
Exclusive Podcast with Jonathan S. Kahan, author 

 

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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Download this podcast to hear about all new updates to the current Good Clinical Practice Question & Answer Reference Guide, May 2013. 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 the regulatory landscape in 2013, and the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance.

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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.

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GCP and Clinical Research Standards in the European Union
Exclusive Interview with Dr. Beat Widler 

 

This exclusive podcast is with Dr. Beat Widler, the key contributor to this year's GCP Q&A Guide's Chapter on "GCP and Clinical Research Standards in the European Union." Hear Dr. Widler's take on issues such as global outsourcing, the pitfalls and opportunities related to global drug development, and the sharing of protocols and protocol standards across industry.

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The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Exclusive Interview with SAM Sather, MS, BSN, CCRA, CCRC 

 

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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