Title
Category
Credits
Event date
Cost
Activation 201- What is the Role of the Activation PM
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 1.00 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. 
5 Tips for Developing and Maintaining an IND
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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.
Everything that a PI Needs to Know about Holding an IND
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 1.00 Participation
$0.00
Course DescriptionKaitlin Morrison, PhD takes you through all of the major responsibilities of holding an LCCC sponsored IND. She takes you through errors made in the past, so you can make sure that you don’t make them on your study.
IND Boot Camp
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
  • 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 AMA PRA Category 1 Credit™ - Non-physician
  • 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 AMA PRA Category 1 Credit™ - Non-physician
  • 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 AMA PRA Category 1 Credit™ - Non-physician
  • 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 AMA PRA Category 1 Credit™ - Non-physician
  • 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 AMA PRA Category 1 Credit™ - Non-physician
  • 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 AMA PRA Category 1 Credit™ - Non-physician
  • 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:  

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