Investigational Product Accountability Best Practices

Duration: 60 Minutes
"An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes." (2002 Applied Clinical Trials). Conducting a clinical trial with a drug or device that is not FDA approved or that is being used in an investigational manner can be daunting. A site must know the federal regulations, and have accountability practices. All this can be very daunting.
Investigational Product Accountability
Instructor: Sarah Fowler Dixon
Product ID: 503721
Objectives of the Presentation
  • Discuss the regulatory framework
  • Become familiar with investigational product best practices
  • Understand when a product is investigational
  • Know the research site's responsibility
Why Should you Attend
This webinar will help clarify information to provide a foundation from which those responsible for investigational product accountability can build to avoid compliance issues and audit errors.

Areas Covered
  • 21 CFR 312
  • 21 CFR 812
  • Good Clinical Practice guideline requirements study conduct
  • Requirements under an Investigational New Drug Number
  • Tracking methods to assist with investigational product accountability
  • Areas that can create audit findings
Who will Benefit
  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • Clinical Research Coordinators, Associates, and Managers
  • Administration in charge of Clinical Research, Clinical Research Sites
  • Contract Research Organizations
  • Regulatory Coordinators
  • Principal Investigator positions, Sub-Investigators
  • Pharmacists
Topic Background
Good Clinical Practices (ICH GCP E6) is becoming the guidance of choice when conducting clinical trials. Following this guideline allows data to be shared amongst the countries that abide by GCP namely, the United States, Japan, and the European Union. One type of clinical trial that often adheres to GCP E6 guidance is a drug trial. When that drug is not FDA approved or it is being used in an investigational manner (off-label) for the purposes of a study an Investigational New Drug Number (IND) is required. In both the IND application and adherence to GCP guidance there are procedures that must followed. Successfully navigated, the investigational drug obtains FDA approval and may be marketed in the United States.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
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