Title
Category
Credits
Event date
Cost
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD takes you through the what you should consider when doing preclinical, manufacturing and clinical work involving Chimeric Antigen Receptor (CAR) T cells.
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take to you about the 3 major reasons that protocols requirement amendments and how to avoid them.
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take you through how to develop and implement a quality management plan to ensure you get good clinical trial results on your investigator-initiated trial (IIT).
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
$0.00
Course DescriptionIn this talk, Kaitlin Morrison, PhD discussing what an administrative letter is and when an administrative letter can be used to clarify a clinical protocol versus when a full amendment is required.  
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
$0.00
Course DescriptionNasrin Babadi, PhD takes you through LCCC’s processes for amending protocols and submitting them to FDA talking about key tips on how to best edit your protocol and applicable FDA regulations for submitting your protocol.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Pages