Title
Category
Credits
Event date
Cost
5 Tips for Developing and Maintaining an IND
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through a quick 5 tips that will help you and your team successfully manage an IND.
IND Boot Camp
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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.
IIT FDA Annual Reports
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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.
IND Safety Reporting- LCCC IITs
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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.
Working with Investigational Assay Results
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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.
Everything a PI Needs to Know about LCCC as an IND Sponsor
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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.
Gene Therapy- FDA and Local Considerations
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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.
Hot and Cold Topics for Investigators
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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:  
LCCC’s Single Subject Exception Policy
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 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.
Activation 101- Who are the Players
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through all the different players and roles involved in clinical trial activation.

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