ACRP 2018 Meeting & Expo


345 - A Global Perspective on Regulations Impacting Clinical Research


Apr 30, 2018 3:00pm ‐ Apr 30, 2018 4:00pm


Credits: None available.

Members: $25.00
Standard: $75.00
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Description

This session will examine several regulatory issues that impact US and global trial operations from multiple perspectives. Topics include US and Latin American trial issues, OTC drugs and personal care products used in clinical trials, and new Certificate of Confidentiality rules. There will also be time set aside for Q&A with the expert panel of ACRP Regulatory Affairs Committee Members.

Learning Objectives:

  • Recognize selected advantages and procedural differences when conducting clinical trials in Latin America
  • Understand when a ‚ÄúCertificate of Confidentiality" is appropriate for your trial, what it covers, and how one is obtained
  • Keep up-to-date with recent key changes to US regulations affecting clinical trials conduct and monitoring

Speaker(s):

  • Sandra (Sam) Sather, MS, BSN, CCRA, CCRC, Vice President, Clinical Pathways, LLC
  • Michael Caswell, PhD, CCRA, CCRC, Vice President, Clinical Evaluations, Consumer Product Testing Company, Inc.
  • Jan Peterson, MS, CCRA, RAC, ASQCBA, ACRP-CP, Senior Regulatory Affairs Advisor, Project Director, EMMES Corporation
  • Anne Blanchard, CCRA, CEO - Development Strategy and Quality Assurance, Blanchad & Asociados - LATINABA
  • Candace Shelton, MS CCRA CCDM, Vice President, Data Management, Imaging Endpoints

Credits Available


A Global Perspective on Regulations Impacting Clinical Research

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