ICH-FDA Good Clinical Practice – Managing Clinical Trials

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This course provides an overview of the critical elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to Sponsor Responsibilities and Quality Management of the clinical trial.

This webinar has been specifically designed to help attendees manage a GCP compliant clinical trial. It will provide a background and understanding of the role played by the Sponsor, IRB, Investigators, and the Regulatory Authorities. Attendees will be taken through the key stages of the clinical trial processes.

Areas to be Covered:

The Principles of ICH GCP
Informed Consent
HIPPA Compliance
Ethics & IRB Responsibilities
Investigator Responsibilities
Sponsor Responsibilites
Quality Management
CRO Selection
Trial Design/Protocol
Trial Management
Investigator Selection
Data Handling/Recordkeeping
Essential Documents
Auditing/ Regulatory Authority Inspections
FDA Warning Letters

Who will Benefit:

Clinical Quality Assurance Professionals
Clinical Research Associates
Project Managers
Study Coordinators
GCP-Focused Regulatory Affairs Professionals

Marie Dorat

Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.

Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.

She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance