Title
Category
Credits
Event date
Cost
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionIn this talk, targeted at the CPO regulatory team, Kaitlin Morrison, PhD talks through how INDs are maintained at LCCC and the responsibilities of study team members.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionNasrin Babadi, PhD takes you through how to write an IND annual report and the LCCC processes surrounding IND annual reports.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD covers how to fill out a MedWatch report form and how/when/why to notify FDA of an SAE.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through when a correlative assay is considered an FDA regulated device and what types of devices require different levels of IRB and FDA approval.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through the sponsor responsibilities outlined by Good Clinical Practices (GCP) and FDA regulations and what LCCC infrastructure and processes are used to meet those obligations.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionIn this talk, which was presented to FDA, IRBs and study teams throughout the US, Kaitlin Morrison, PhD takes you through gene therapy trials and what you need to know about them beyond your typical IIT process. This includes insights into specific protocol requirements and additional review bodies that will oversee your study.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through the top topics investigators are asking about and the other questions that they should be asking too.These topics include:  
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionIn this talk by Kaitlin Morrison, PhD and Carrie Lee, MD, MPH, Kaitlin takes your through LCCC’s policy on single subject exceptions, why we do not allow eligibility single subject exceptions on IITs and what the process is to ensure proper regulatory approval for other types of single subject exceptions.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through all the different players and roles involved in clinical trial activation.
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
$0.00
Course DescriptionThis talk given by Kaitlin Morrison, PhD takes you through the role of the activation project manager and how they facilitate activation of treatment clinical trials. 

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